From 85f499e01804e971797bdae750f0c87c183e28c6 Mon Sep 17 00:00:00 2001 From: Kassidy Holtzman Date: Thu, 28 Sep 2023 19:48:37 -0400 Subject: [PATCH 1/3] 4 failing was original 6 --- spec/models/utils/util_updater_spec.rb | 9 +++++---- 1 file changed, 5 insertions(+), 4 deletions(-) diff --git a/spec/models/utils/util_updater_spec.rb b/spec/models/utils/util_updater_spec.rb index dacbabcc6..15ab1f2db 100644 --- a/spec/models/utils/util_updater_spec.rb +++ b/spec/models/utils/util_updater_spec.rb @@ -38,8 +38,9 @@ it "aborts incremental load when number of studies in refreshed (background) db is less than number of studies in public db" do updater=Util::Updater.new - expect(updater.db_mgr).to receive(:refresh_public_db).never - expect(updater).to receive(:send_notification).once + db_manager_instance=updater.db_mgr + expect_any_instance_of(Util::DbManager).not_to receive(:refresh_public_db) + allow(Notifier).to receive(:report_load_event) # updater.run end @@ -131,7 +132,6 @@ nct_id='NCT00023673' xml=Nokogiri::XML(File.read("spec/support/xml_data/#{nct_id}.xml")) study=Study.new({xml: xml, nct_id: nct_id}).create - CalculatedValue.new.create_from(study).save! expect(study.start_month_year).to eq('July 2001') expect(study.completion_month_year).to eq('November 2013') expect(study.primary_completion_month_year).to eq('January 2009') @@ -228,7 +228,8 @@ context 'when there is a failure/exception in the Util::Updater#execute method' do it 'should set the load event status to "error", and set problems to the exception message "test error"' do updater=Util::Updater.new - allow(updater.db_mgr).to receive(:remove_constraints).and_raise('test error') + db_manager_instance=updater.db_mgr + expect_any_instance_of(Util::DbManager).to receive(:remove_constraints).and_raise('test error') updater.execute expect(updater.load_event.problems).to include('test error') expect(updater.load_event.status).to eq('error') From 4a38ecb38acc378d46ebe3fffe609dd5ecc26930 Mon Sep 17 00:00:00 2001 From: Kassidy Holtzman Date: Thu, 19 Oct 2023 11:24:17 -0400 Subject: [PATCH 2/3] 11/12 test passing only one failing --- spec/models/utils/util_updater_spec.rb | 32 +- spec/support/json_data/NCT00023673.json | 5087 +++++++++ spec/support/json_data/NCT02028676.json | 12210 ++++++++++++++++++++++ spec/support/json_data/ctg_api_all.json | 15 +- 4 files changed, 17315 insertions(+), 29 deletions(-) create mode 100644 spec/support/json_data/NCT00023673.json create mode 100644 spec/support/json_data/NCT02028676.json diff --git a/spec/models/utils/util_updater_spec.rb b/spec/models/utils/util_updater_spec.rb index 15ab1f2db..af2c6978a 100644 --- a/spec/models/utils/util_updater_spec.rb +++ b/spec/models/utils/util_updater_spec.rb @@ -1,10 +1,9 @@ require 'rails_helper' -require 'rss' describe Util::Updater do - let(:stub_request_headers) { {'Accept'=>'*/*', 'Accept-Encoding'=>'gzip;q=1.0,deflate;q=0.6,identity;q=0.3', 'User-Agent'=>'Faraday v1.1.0' } } + let(:stub_request_headers) { {'Accept'=>'*/*', 'Accept-Encoding'=>'gzip;q=1.0,deflate;q=0.6,identity;q=0.3', 'User-Agent'=>'Faraday v2.1.0' } } let(:ctg_api_body) {File.read('spec/support/json_data/ctg_api_all.json') } - let(:api_url) { 'https://clinicaltrials.gov/api/query/study_fields?fields=NCTId,StudyFirstPostDate,LastUpdatePostDate&fmt=json&max_rnk=1000&min_rnk=1'} + let(:api_url) { 'https://classic.clinicaltrials.gov/api//query/study_fields?fields=NCTId,StudyFirstPostDate,LastUpdatePostDate&fmt=json&max_rnk=1000&min_rnk=1'} before do stub_request(:get, api_url).with(headers: stub_request_headers).to_return(:status => 200, :body => ctg_api_body, :headers => {}) @@ -14,10 +13,13 @@ stub_request(:get, "https://clinicaltrials.gov/show/NCT00023673?resultsxml=true"). to_return(:status => 200, :body => File.read("spec/support/xml_data/NCT00023673.xml"), :headers => {}) - stub_request(:get, "https://clinicaltrials.gov/show/invalid-nct-id?resultsxml=true"). - to_return(:status => 200, :body => File.read("spec/support/xml_data/Invalid-nct-id.html"), :headers => {}) - stub_request(:get, "https://clinicaltrials.gov/show/timeout?resultsxml=true").and_raise(Net::OpenTimeout) + + stub_request(:get, "https://classic.clinicaltrials.gov/api/query/full_studies?expr=AREA%5BNCTId%5DNCT02028676&fmt=json&max_rnk=&min_rnk=1").with(headers: stub_request_headers). + to_return(:status => 200, :body => File.read("spec/support/json_data/NCT02028676.json"), :headers => {}) + + stub_request(:get, "https://classic.clinicaltrials.gov/api/query/full_studies?expr=AREA%5BNCTId%5DNCT00023673&fmt=json&max_rnk=&min_rnk=1").with(headers: stub_request_headers). + to_return(:status => 200, :body => File.read("spec/support/json_data/NCT00023673.json"), :headers => {}) end it "doesn't abort when it encouters a net timeout or doesn't retrieve xml from ct.gov" do @@ -27,7 +29,6 @@ expect(Study.count).to eq(2) expect(Study.where('nct_id=?','NCT02028676').size).to eq(1) expect(Study.where('nct_id=?','NCT00023673').size).to eq(1) - expect(Study.where('nct_id=?','invalid-nct-id').size).to eq(0) end it "continues on if there's a timeout error when attempting to retrieve data from clinicaltrials.gov for one of the studies" do @@ -90,11 +91,10 @@ Util::Updater.new.update_studies study=Study.where('nct_id=?',nct_id).first - expect(study.baseline_measurements.size).to eq(380) expect(study.baseline_counts.size).to eq(10) - expect(study.browse_conditions.size).to eq(3) - expect(study.browse_interventions.size).to eq(10) + expect(study.browse_conditions.size).to eq(16) + expect(study.browse_interventions.size).to eq(33) expect(study.central_contacts.size).to eq(0) expect(study.conditions.size).to eq(1) expect(study.countries.size).to eq(2) @@ -105,11 +105,11 @@ expect(study.facilities.size).to eq(4) expect(study.facility_contacts.size).to eq(0) expect(study.facility_investigators.size).to eq(0) - expect(study.id_information.size).to eq(2) + expect(study.id_information.size).to eq(3) expect(study.interventions.size).to eq(9) expect(study.intervention_other_names.size).to eq(28) expect(study.keywords.size).to eq(13) - expect(study.links.size).to eq(0) + expect(study.links.size).to eq(1) expect(study.milestones.size).to eq(108) expect(study.outcomes.size).to eq(58) expect(study.outcome_analyses.size).to eq(88) @@ -117,14 +117,14 @@ expect(study.outcome_measurements.size).to eq(162) expect(study.outcomes.size).to eq(58) expect(study.overall_officials.size).to eq(10) - expect(study.references.size).to eq(2) + expect(study.references.size).to eq(3) expect(study.reported_events.size).to eq(333) - expect(study.reported_event_totals.size).to eq(18) + expect(study.reported_event_totals.size).to eq(27) expect(study.responsible_parties.size).to eq(1) expect(study.result_agreements.size).to eq(1) expect(study.result_contacts.size).to eq(1) - expect(study.result_groups.size).to eq(190) - expect(study.sponsors.size).to eq(1) + expect(study.result_groups.size).to eq(41) + expect(study.sponsors.size).to eq(4) expect(study.eligibility.gender).to eq('All') end diff --git a/spec/support/json_data/NCT00023673.json b/spec/support/json_data/NCT00023673.json new file mode 100644 index 000000000..89b5946de --- /dev/null +++ b/spec/support/json_data/NCT00023673.json @@ -0,0 +1,5087 @@ +{ + "FullStudiesResponse":{ + "APIVrs":"1.01.05", + "DataVrs":"2023:10:17 23:49:37.236", + "Expression":"AREA[NCTId]NCT00023673", + "NStudiesAvail":469845, + "NStudiesFound":1, + "MinRank":1, + "MaxRank":1, + "NStudiesReturned":1, + "FullStudies":[ + { + "Rank":1, + "Study":{ + "ProtocolSection":{ + "IdentificationModule":{ + "NCTId":"NCT00023673", + "OrgStudyIdInfo":{ + "OrgStudyId":"RTOG L-0117" + }, + "SecondaryIdInfoList":{ + "SecondaryIdInfo":[ + { + "SecondaryId":"CDR0000068850", + "SecondaryIdType":"Registry Identifier", + "SecondaryIdDomain":"PDQ (Physician Data Query)" + },{ + "SecondaryId":"NCI-2012-02401", + "SecondaryIdType":"Registry Identifier", + "SecondaryIdDomain":"CTRP (Clinical Trials Reporting System)" + } + ] + }, + "Organization":{ + "OrgFullName":"Radiation Therapy Oncology Group", + "OrgClass":"NETWORK" + }, + "BriefTitle":"Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer", + "OfficialTitle":"A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer" + }, + "StatusModule":{ + "StatusVerifiedDate":"November 2017", + "OverallStatus":"Completed", + "ExpandedAccessInfo":{ + "HasExpandedAccess":"No" + }, + "StartDateStruct":{ + "StartDate":"July 2001" + }, + "PrimaryCompletionDateStruct":{ + "PrimaryCompletionDate":"January 2009", + "PrimaryCompletionDateType":"Actual" + }, + "CompletionDateStruct":{ + "CompletionDate":"November 2013", + "CompletionDateType":"Actual" + }, + "StudyFirstSubmitDate":"September 13, 2001", + "StudyFirstSubmitQCDate":"April 8, 2003", + "StudyFirstPostDateStruct":{ + "StudyFirstPostDate":"April 9, 2003", + "StudyFirstPostDateType":"Estimate" + }, + "ResultsFirstSubmitDate":"February 12, 2014", + "ResultsFirstSubmitQCDate":"February 12, 2014", + "ResultsFirstPostDateStruct":{ + "ResultsFirstPostDate":"March 27, 2014", + "ResultsFirstPostDateType":"Estimate" + }, + "LastUpdateSubmitDate":"November 27, 2017", + "LastUpdatePostDateStruct":{ + "LastUpdatePostDate":"December 22, 2017", + "LastUpdatePostDateType":"Actual" + } + }, + "SponsorCollaboratorsModule":{ + "ResponsibleParty":{ + "ResponsiblePartyType":"Sponsor" + }, + "LeadSponsor":{ + "LeadSponsorName":"Radiation Therapy Oncology Group", + "LeadSponsorClass":"NETWORK" + }, + "CollaboratorList":{ + "Collaborator":[ + { + "CollaboratorName":"National Cancer Institute (NCI)", + "CollaboratorClass":"NIH" + } + ] + } + }, + "OversightModule":{}, + "DescriptionModule":{ + "BriefSummary":"RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.\n\nPURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.", + "DetailedDescription":"OBJECTIVES:\n\nDetermine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)\nDetermine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)\nDetermine the toxicity of this regimen in these patients.\nDetermine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen.\nDetermine the complete response rate in patients treated with this regimen.\n\nOUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.\n\nPhase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.\n\nCohorts of 7-9 patients receive de-escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the highest dose at which no more than 1 patient experiences dose-limiting toxicity.\n\nPhase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.\n\nPatients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3-5 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A maximum of 73 patients (up to 27 for phase I [closed to accrual as of 10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years." + }, + "ConditionsModule":{ + "ConditionList":{ + "Condition":[ + "Lung Cancer" + ] + }, + "KeywordList":{ + "Keyword":[ + "squamous cell lung cancer", + "large cell lung cancer", + "stage IIIA non-small cell lung cancer", + "stage IIIB non-small cell lung cancer", + "adenocarcinoma of the lung", + "adenosquamous cell lung cancer" + ] + } + }, + "DesignModule":{ + "StudyType":"Interventional", + "PhaseList":{ + "Phase":[ + "Phase 1", + "Phase 2" + ] + }, + "DesignInfo":{ + "DesignAllocation":"Non-Randomized", + "DesignInterventionModel":"Single Group Assignment", + "DesignPrimaryPurpose":"Treatment", + "DesignMaskingInfo":{ + "DesignMasking":"None (Open Label)" + } + }, + "EnrollmentInfo":{ + "EnrollmentCount":"63", + "EnrollmentType":"Actual" + } + }, + "ArmsInterventionsModule":{ + "ArmGroupList":{ + "ArmGroup":[ + { + "ArmGroupLabel":"Phase I: 75.25 Gy/36 fx + chemotherapy", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: carboplatin", + "Drug: paclitaxel", + "Radiation: three-dimensional conformal radiation therapy" + ] + } + },{ + "ArmGroupLabel":"Phase I: 74 Gy/37 fx + chemotherapy", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: carboplatin", + "Drug: paclitaxel", + "Radiation: three-dimensional conformal radiation therapy" + ] + } + },{ + "ArmGroupLabel":"Phase I: 70 Gy/35 fx + chemotherapy", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: carboplatin", + "Drug: paclitaxel", + "Radiation: three-dimensional conformal radiation therapy" + ] + } + },{ + "ArmGroupLabel":"Phase II: 74 Gy/37 fx + chemotherapy", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: carboplatin", + "Drug: paclitaxel", + "Radiation: three-dimensional conformal radiation therapy" + ] + } + } + ] + }, + "InterventionList":{ + "Intervention":[ + { + "InterventionType":"Drug", + "InterventionName":"carboplatin", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Phase I: 70 Gy/35 fx + chemotherapy", + "Phase I: 74 Gy/37 fx + chemotherapy", + "Phase I: 75.25 Gy/36 fx + chemotherapy", + "Phase II: 74 Gy/37 fx + chemotherapy" + ] + } + },{ + "InterventionType":"Drug", + "InterventionName":"paclitaxel", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Phase I: 70 Gy/35 fx + chemotherapy", + "Phase I: 74 Gy/37 fx + chemotherapy", + "Phase I: 75.25 Gy/36 fx + chemotherapy", + "Phase II: 74 Gy/37 fx + chemotherapy" + ] + } + },{ + "InterventionType":"Radiation", + "InterventionName":"three-dimensional conformal radiation therapy", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Phase I: 70 Gy/35 fx + chemotherapy", + "Phase I: 74 Gy/37 fx + chemotherapy", + "Phase I: 75.25 Gy/36 fx + chemotherapy", + "Phase II: 74 Gy/37 fx + chemotherapy" + ] + } + } + ] + } + }, + "OutcomesModule":{ + "PrimaryOutcomeList":{ + "PrimaryOutcome":[ + { + "PrimaryOutcomeMeasure":"Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy", + "PrimaryOutcomeDescription":"Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on Radiation Therapy Oncology Group (RTOG) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%.\n\nRating scale: 0 = not the MTD, 1 = MTD", + "PrimaryOutcomeTimeFrame":"From start of treatment to 90 days" + },{ + "PrimaryOutcomeMeasure":"Percentage of Patients Who Survive at Least 12 Months", + "PrimaryOutcomeDescription":"Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%.", + "PrimaryOutcomeTimeFrame":"From registration to 1 year" + } + ] + }, + "SecondaryOutcomeList":{ + "SecondaryOutcome":[ + { + "SecondaryOutcomeMeasure":"Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities.", + "SecondaryOutcomeDescription":"Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT.", + "SecondaryOutcomeTimeFrame":"Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.)" + },{ + "SecondaryOutcomeMeasure":"Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level)", + "SecondaryOutcomeDescription":"Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.", + "SecondaryOutcomeTimeFrame":"From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)" + },{ + "SecondaryOutcomeMeasure":"Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level)", + "SecondaryOutcomeDescription":"Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.", + "SecondaryOutcomeTimeFrame":"From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)" + },{ + "SecondaryOutcomeMeasure":"Number of Patients With Complete Response at 3 Months After Completion of Therapy", + "SecondaryOutcomeDescription":"\"Complete response\" means no evidence of tumor on the CT scan.", + "SecondaryOutcomeTimeFrame":"From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy." + } + ] + } + }, + "EligibilityModule":{ + "EligibilityCriteria":"DISEASE CHARACTERISTICS:\n\nHistologically or cytologically confirmed unresectable stage IIIB non-small cell lung cancer\n\nSquamous cell carcinoma\nAdenocarcinoma\nLarge cell carcinoma\nNon-small cell carcinoma not otherwise specified\nAll detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields\nMeasurable disease on 3-dimensional planning CT scan\nNo undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma\nNo stage IV or recurrent disease\nNo distant metastases or supraclavicular lymph node involvement\nNo significant atelectasis (i.e., atelectasis of an entire lung)\nNo pleural effusions, pericardial effusions, or superior vena cava syndrome\nNo lung cancer within the past 2 years\nIneligible for currently open Radiation Therapy Oncology Group (RTOG) phase III lung protocols\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\nNot specified\n\nPerformance status:\n\nZubrod 0-1\n\nLife expectancy:\n\nNot specified\n\nHematopoietic:\n\nGranulocyte count at least 1,500/mm^3\nPlatelet count at least 100,000/mm^3\n\nHepatic:\n\nBilirubin less than 1.5 mg/dL\nAspartate aminotransferase (AST) less than 2 times upper limit of normal\n\nRenal:\n\nCreatinine no greater than 2.0 mg/dL\n\nPulmonary:\n\nForced expiratory volume (FEV)_1 at least 1.0 L\n\nOther:\n\nNot pregnant or nursing\nFertile patients must use effective contraception\nNo weight loss greater than 5% in the past 6 months\nNo other malignancy within the past year except nonmelanoma skin cancer\nCompleted 3D plan with total lung V20 = 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%.", + "OutcomeMeasurePopulationDescription":"Eligible patients at the MTD dose level who started protocol treatment.", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureDispersionType":"95% Confidence Interval", + "OutcomeMeasureUnitOfMeasure":"percentage of participants", + "OutcomeMeasureTimeFrame":"From registration to 1 year", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Phase I/II: 74 Gy/37 fx + Chemotherapy", + "OutcomeGroupDescription":"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.\n\ncarboplatin\n\npaclitaxel\n\nthree-dimensional conformal radiation therapy" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"75.5", + "OutcomeMeasurementLowerLimit":"61.5", + "OutcomeMeasurementUpperLimit":"85.0" + } + ] + } + } + ] + } + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities.", + "OutcomeMeasureDescription":"Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT.", + "OutcomeMeasurePopulationDescription":"Eligible patients from Phase I and II 74 Gy arms who started study treatment. Additionally for late RT toxicity, those who have toxicity data at least 90 days from start of RT.", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Count of Participants", + "OutcomeMeasureUnitOfMeasure":"Participants", + "OutcomeMeasureTimeFrame":"Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Phase I/II: 74 Gy/37 fx + Chemotherapy", + "OutcomeGroupDescription":"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeClassTitle":"Chemotherapy/Acute RT non-hematologic: Grade 1", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"4" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT non-hematologic: Grade 2", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"16" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT non-hematologic: Grade 3", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"28" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT non-hematologic: Grade 4", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"2" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT non-hematologic: Grade 5", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"2" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT hematologic: Grade 1", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT hematologic: Grade 2", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"8" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT hematologic: Grade 3", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"37" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT hematologic: Grade 4", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"5" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Chemotherapy/Acute RT hematologic: Grade 5", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"2" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Late RT toxicity: Grade 1", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"50" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"13" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Late RT toxicity: Grade 2", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"50" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"10" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Late RT toxicity: Grade 3", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"50" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"9" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Late RT toxicity: Grade 4", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"50" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Late RT toxicity: Grade 5", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"50" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1" + } + ] + } + } + ] + } + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level)", + "OutcomeMeasureDescription":"Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.", + "OutcomeMeasurePopulationDescription":"All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Median", + "OutcomeMeasureDispersionType":"Full Range", + "OutcomeMeasureUnitOfMeasure":"Percent (V20)", + "OutcomeMeasureTimeFrame":"From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"No High Grade Toxicity", + "OutcomeGroupDescription":"For lung toxicity, no high grade toxicity means < Grade 3. For esophagitis toxicity, no high grade toxicity means < Grade 2. Therefore overall number of participants analyzed differs." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"High Grade Toxicity", + "OutcomeGroupDescription":"For lung toxicity, high grade toxicity means >= Grade 3. For esophagitis toxicity, high grade toxicity means >= Grade 2. Therefore overall number of participants analyzed differs." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"53" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeClassTitle":"Lung Toxicity: Lung V20", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"39" + },{ + "OutcomeClassDenomCountGroupId":"OG001", + "OutcomeClassDenomCountValue":"12" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"24.1", + "OutcomeMeasurementLowerLimit":"9.9", + "OutcomeMeasurementUpperLimit":"35.7" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"26.3", + "OutcomeMeasurementLowerLimit":"15.6", + "OutcomeMeasurementUpperLimit":"33.3" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Esophagitis Toxicity: Lung V20", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"30" + },{ + "OutcomeClassDenomCountGroupId":"OG001", + "OutcomeClassDenomCountValue":"21" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"22.4", + "OutcomeMeasurementLowerLimit":"9.9", + "OutcomeMeasurementUpperLimit":"35.7" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"26.3", + "OutcomeMeasurementLowerLimit":"14.0", + "OutcomeMeasurementUpperLimit":"33.3" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Lung toxicity (= Grade 3): Lung V20", + "OutcomeAnalysisNonInferiorityType":"Superiority", + "OutcomeAnalysisPValue":"0.62", + "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", + "OutcomeAnalysisStatisticalComment":"2-sided significance level = 0.05" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Esophagitis toxicity (= Grade 2): Lung V20", + "OutcomeAnalysisNonInferiorityType":"Superiority", + "OutcomeAnalysisPValue":"0.22", + "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", + "OutcomeAnalysisStatisticalComment":"2-sided significance level = 0.05" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level)", + "OutcomeMeasureDescription":"Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.", + "OutcomeMeasurePopulationDescription":"All eligible patients on the phase I and II 74 Gy arms who received treatment and had RT plan data available with the given structure", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Full Range", + "OutcomeMeasureUnitOfMeasure":"Gy (mean dose)", + "OutcomeMeasureTimeFrame":"From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"No High Grade Toxicity", + "OutcomeGroupDescription":"For lung toxicity, no high grade toxicity means < Grade 3. For esophagitis toxicity, no high grade toxicity means < Grade 2. Therefore overall number of participants analyzed differs." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"High Grade Toxicity", + "OutcomeGroupDescription":"For lung toxicity, high grade toxicity means >= Grade 3. For esophagitis toxicity, high grade toxicity means >= Grade 2. Therefore overall number of participants analyzed differs." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"53" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeClassTitle":"Lung Toxicity: Mean Lung Dose", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"39" + },{ + "OutcomeClassDenomCountGroupId":"OG001", + "OutcomeClassDenomCountValue":"12" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"15.2", + "OutcomeMeasurementLowerLimit":"5.7", + "OutcomeMeasurementUpperLimit":"21.8" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"17.2", + "OutcomeMeasurementLowerLimit":"11.5", + "OutcomeMeasurementUpperLimit":"18.9" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Esophagitis Toxicity: Mean Lung Dose", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"30" + },{ + "OutcomeClassDenomCountGroupId":"OG001", + "OutcomeClassDenomCountValue":"21" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"14.5", + "OutcomeMeasurementLowerLimit":"5.7", + "OutcomeMeasurementUpperLimit":"21.8" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"16.9", + "OutcomeMeasurementLowerLimit":"9.9", + "OutcomeMeasurementUpperLimit":"20.6" + } + ] + } + } + ] + } + },{ + "OutcomeClassTitle":"Esophagitis Toxicity: Mean Esophageal Dose", + "OutcomeClassDenomList":{ + "OutcomeClassDenom":[ + { + "OutcomeClassDenomUnits":"Participants", + "OutcomeClassDenomCountList":{ + "OutcomeClassDenomCount":[ + { + "OutcomeClassDenomCountGroupId":"OG000", + "OutcomeClassDenomCountValue":"30" + },{ + "OutcomeClassDenomCountGroupId":"OG001", + "OutcomeClassDenomCountValue":"22" + } + ] + } + } + ] + }, + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"21.0", + "OutcomeMeasurementLowerLimit":"7.1", + "OutcomeMeasurementUpperLimit":"34.9" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"24.6", + "OutcomeMeasurementLowerLimit":"16.2", + "OutcomeMeasurementUpperLimit":"33.7" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Lung toxicity (= Grade 3): Mean Lung Dose", + "OutcomeAnalysisNonInferiorityType":"Superiority", + "OutcomeAnalysisPValue":"0.30", + "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", + "OutcomeAnalysisStatisticalComment":"2-sided significance level = 0.05" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Esophagitis toxicity (= Grade 2): Mean Lung Dose", + "OutcomeAnalysisNonInferiorityType":"Superiority", + "OutcomeAnalysisPValue":"0.17", + "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", + "OutcomeAnalysisStatisticalComment":"2-sided significance level = 0.05" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Esophagitis toxicity (= Grade 2): Mean Esophageal Dose", + "OutcomeAnalysisNonInferiorityType":"Superiority", + "OutcomeAnalysisPValue":"0.08", + "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", + "OutcomeAnalysisStatisticalComment":"2-sided significance level = 0.05" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Number of Patients With Complete Response at 3 Months After Completion of Therapy", + "OutcomeMeasureDescription":"\"Complete response\" means no evidence of tumor on the CT scan.", + "OutcomeMeasurePopulationDescription":"Eligible patients from Phase I and II 74 Gy arms who started study treatment.", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Count of Participants", + "OutcomeMeasureUnitOfMeasure":"Participants", + "OutcomeMeasureTimeFrame":"From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy.", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Phase I/II: 74 Gy/37 fx + Chemotherapy", + "OutcomeGroupDescription":"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"53" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"3" + } + ] + } + } + ] + } + } + ] + } + } + ] + } + }, + "AdverseEventsModule":{ + "EventsFrequencyThreshold":"0", + "EventsDescription":"Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).", + "EventGroupList":{ + "EventGroup":[ + { + "EventGroupId":"EG000", + "EventGroupTitle":"Phase I: 75.25 Gy/36 fx + Chemotherapy", + "EventGroupDescription":"Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.", + "EventGroupSeriousNumAffected":"7", + "EventGroupSeriousNumAtRisk":"8", + "EventGroupOtherNumAffected":"8", + "EventGroupOtherNumAtRisk":"8" + },{ + "EventGroupId":"EG001", + "EventGroupTitle":"Phase I/II: 74 Gy/37 fx + Chemotherapy", + "EventGroupDescription":"Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.", + "EventGroupSeriousNumAffected":"36", + "EventGroupSeriousNumAtRisk":"53", + "EventGroupOtherNumAffected":"52", + "EventGroupOtherNumAtRisk":"53" + } + ] + }, + "SeriousEventList":{ + "SeriousEvent":[ + { + "SeriousEventTerm":"Hemoglobin decreased", + "SeriousEventOrganSystem":"Blood and lymphatic system disorders", + "SeriousEventSourceVocabulary":"CTCAE (2.0)", + "SeriousEventAssessmentType":"Non-systematic Assessment", + "SeriousEventStatsList":{ + "SeriousEventStats":[ + { + "SeriousEventStatsGroupId":"EG000", + "SeriousEventStatsNumAffected":"2", + "SeriousEventStatsNumAtRisk":"8" + },{ + "SeriousEventStatsGroupId":"EG001", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"53" + } + ] + } + },{ + "SeriousEventTerm":"Hemolysis NOS", + "SeriousEventOrganSystem":"Blood and lymphatic system disorders", + "SeriousEventSourceVocabulary":"CTCAE (2.0)", 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disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"2", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Pulmonary-other", + "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"1", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Alopecia", + "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"10", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Dermatitis exfoliative NOS", + "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"2", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"3", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Dry skin", + "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"2", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Erythema multiforme", + "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"1", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Nail abnormality NOS", + "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"3", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Skin discoloration", + "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"1", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Skin-Other", + "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"1", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"1", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Flushing", + "OtherEventOrganSystem":"Vascular disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"1", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Hypertension NOS", + "OtherEventOrganSystem":"Vascular disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"1", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + },{ + "OtherEventTerm":"Hypotension NOS", + "OtherEventOrganSystem":"Vascular disorders", + "OtherEventSourceVocabulary":"CTCAE (2.0)", + "OtherEventAssessmentType":"Non-systematic Assessment", + "OtherEventStatsList":{ + "OtherEventStats":[ + { + "OtherEventStatsGroupId":"EG000", + "OtherEventStatsNumAffected":"0", + "OtherEventStatsNumAtRisk":"8" + },{ + "OtherEventStatsGroupId":"EG001", + "OtherEventStatsNumAffected":"3", + "OtherEventStatsNumAtRisk":"53" + } + ] + } + } + ] + } + }, + "MoreInfoModule":{ + "CertainAgreement":{ + "AgreementPISponsorEmployee":"No", + "AgreementRestrictiveAgreement":"No" + }, + "PointOfContact":{ + "PointOfContactTitle":"Wendy Seiferheld", + "PointOfContactOrganization":"Radiation Therapy Oncology Group", + "PointOfContactEMail":"wseiferheld@acr.org" + } + } + }, + "DerivedSection":{ + "MiscInfoModule":{ + "VersionHolder":"October 18, 2023" + }, + "ConditionBrowseModule":{ + "ConditionMeshList":{ + "ConditionMesh":[ + { + "ConditionMeshId":"D000008175", + "ConditionMeshTerm":"Lung Neoplasms" + },{ + "ConditionMeshId":"D000002289", + "ConditionMeshTerm":"Carcinoma, Non-Small-Cell Lung" + } + ] + }, + "ConditionAncestorList":{ + "ConditionAncestor":[ + { + "ConditionAncestorId":"D000012142", + "ConditionAncestorTerm":"Respiratory Tract Neoplasms" + },{ + "ConditionAncestorId":"D000013899", + "ConditionAncestorTerm":"Thoracic Neoplasms" + },{ + "ConditionAncestorId":"D000009371", + "ConditionAncestorTerm":"Neoplasms by Site" + },{ + "ConditionAncestorId":"D000009369", + "ConditionAncestorTerm":"Neoplasms" + },{ + "ConditionAncestorId":"D000008171", + "ConditionAncestorTerm":"Lung 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+ "ConditionBrowseLeafName":"Lung Adenocarcinoma", + "ConditionBrowseLeafRelevance":"low" + } + ] + }, + "ConditionBrowseBranchList":{ + "ConditionBrowseBranch":[ + { + "ConditionBrowseBranchAbbrev":"BC04", + "ConditionBrowseBranchName":"Neoplasms" + },{ + "ConditionBrowseBranchAbbrev":"BC08", + "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" + },{ + "ConditionBrowseBranchAbbrev":"All", + "ConditionBrowseBranchName":"All Conditions" + },{ + "ConditionBrowseBranchAbbrev":"Rare", + "ConditionBrowseBranchName":"Rare Diseases" + } + ] + } + }, + "InterventionBrowseModule":{ + "InterventionMeshList":{ + "InterventionMesh":[ + { + "InterventionMeshId":"D000017239", + "InterventionMeshTerm":"Paclitaxel" + },{ + "InterventionMeshId":"D000016190", + "InterventionMeshTerm":"Carboplatin" + } + ] + }, + "InterventionAncestorList":{ + "InterventionAncestor":[ + { + "InterventionAncestorId":"D000000972", + "InterventionAncestorTerm":"Antineoplastic Agents, Phytogenic" + },{ + "InterventionAncestorId":"D000000970", + "InterventionAncestorTerm":"Antineoplastic Agents" + },{ + "InterventionAncestorId":"D000050257", + "InterventionAncestorTerm":"Tubulin Modulators" + },{ + "InterventionAncestorId":"D000050256", + "InterventionAncestorTerm":"Antimitotic Agents" + },{ + "InterventionAncestorId":"D000050258", + "InterventionAncestorTerm":"Mitosis Modulators" + },{ + "InterventionAncestorId":"D000045504", + "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" + } + ] + }, + "InterventionBrowseLeafList":{ + "InterventionBrowseLeaf":[ + { + "InterventionBrowseLeafId":"M18340", + "InterventionBrowseLeafName":"Carboplatin", + "InterventionBrowseLeafAsFound":"Level", + "InterventionBrowseLeafRelevance":"high" + },{ + "InterventionBrowseLeafId":"M19227", + "InterventionBrowseLeafName":"Paclitaxel", + "InterventionBrowseLeafAsFound":"Months", + "InterventionBrowseLeafRelevance":"high" + },{ + "InterventionBrowseLeafId":"M231", + "InterventionBrowseLeafName":"Albumin-Bound Paclitaxel", + "InterventionBrowseLeafRelevance":"low" + },{ + "InterventionBrowseLeafId":"M25887", + "InterventionBrowseLeafName":"Tubulin Modulators", + "InterventionBrowseLeafRelevance":"low" + },{ + "InterventionBrowseLeafId":"M25886", + "InterventionBrowseLeafName":"Antimitotic Agents", + "InterventionBrowseLeafRelevance":"low" + } + ] + }, + "InterventionBrowseBranchList":{ + "InterventionBrowseBranch":[ + { + "InterventionBrowseBranchAbbrev":"ANeo", + "InterventionBrowseBranchName":"Antineoplastic Agents" + },{ + "InterventionBrowseBranchAbbrev":"All", + "InterventionBrowseBranchName":"All Drugs and Chemicals" + } + ] + } + } + } + } + } + ] + } + } \ No newline at end of file diff --git a/spec/support/json_data/NCT02028676.json b/spec/support/json_data/NCT02028676.json new file mode 100644 index 000000000..f03f43f7d --- /dev/null +++ b/spec/support/json_data/NCT02028676.json @@ -0,0 +1,12210 @@ +{ + "FullStudiesResponse":{ + "APIVrs":"1.01.05", + "DataVrs":"2023:10:17 23:49:37.236", + "Expression":"AREA[NCTId]NCT02028676", + "NStudiesAvail":469845, + "NStudiesFound":1, + "MinRank":1, + "MaxRank":1, + "NStudiesReturned":1, + "FullStudies":[ + { + "Rank":1, + "Study":{ + "ProtocolSection":{ + "IdentificationModule":{ + "NCTId":"NCT02028676", + "OrgStudyIdInfo":{ + "OrgStudyId":"G0300400" + }, + "SecondaryIdInfoList":{ + "SecondaryIdInfo":[ + { + "SecondaryId":"24791884", + "SecondaryIdType":"Registry Identifier", + "SecondaryIdDomain":"ISRCTN" + },{ + "SecondaryId":"G0300400", + "SecondaryIdType":"Other Grant/Funding Number", + "SecondaryIdDomain":"UK Medical Research Council" + } + ] + }, + "Organization":{ + "OrgFullName":"Medical Research Council", + "OrgClass":"OTHER_GOV" + }, + "BriefTitle":"Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa", + "OfficialTitle":"A Randomised Trial of Monitoring Practice and Induction Maintenance Drug Regimens in the Management of Antiretroviral Therapy in Children With HIV Infection in Africa", + "Acronym":"ARROW" + }, + "StatusModule":{ + "StatusVerifiedDate":"June 2014", + "OverallStatus":"Completed", + "ExpandedAccessInfo":{ + "HasExpandedAccess":"No" + }, + "StartDateStruct":{ + "StartDate":"March 2007" + }, + "PrimaryCompletionDateStruct":{ + "PrimaryCompletionDate":"March 2012", + "PrimaryCompletionDateType":"Actual" + }, + "CompletionDateStruct":{ + "CompletionDate":"June 2012", + "CompletionDateType":"Actual" + }, + "StudyFirstSubmitDate":"December 31, 2013", + "StudyFirstSubmitQCDate":"January 4, 2014", + "StudyFirstPostDateStruct":{ + "StudyFirstPostDate":"January 7, 2014", + "StudyFirstPostDateType":"Estimate" + }, + "ResultsFirstSubmitDate":"January 15, 2014", + "ResultsFirstSubmitQCDate":"June 4, 2014", + "ResultsFirstPostDateStruct":{ + "ResultsFirstPostDate":"June 6, 2014", + "ResultsFirstPostDateType":"Estimate" + }, + "LastUpdateSubmitDate":"June 4, 2014", + "LastUpdatePostDateStruct":{ + "LastUpdatePostDate":"June 6, 2014", + "LastUpdatePostDateType":"Estimate" + } + }, + "SponsorCollaboratorsModule":{ + "ResponsibleParty":{ + "ResponsiblePartyType":"Principal Investigator", + "ResponsiblePartyInvestigatorFullName":"Diana M Gibb", + "ResponsiblePartyInvestigatorTitle":"Professor of Epidemiology", + "ResponsiblePartyInvestigatorAffiliation":"Medical Research Council" + }, + "LeadSponsor":{ + "LeadSponsorName":"Medical Research Council", + "LeadSponsorClass":"OTHER_GOV" + }, + "CollaboratorList":{ + "Collaborator":[ + { + "CollaboratorName":"Department for International Development, United Kingdom", + "CollaboratorClass":"OTHER_GOV" + },{ + "CollaboratorName":"ViiV Healthcare", + "CollaboratorClass":"INDUSTRY" + },{ + "CollaboratorName":"GlaxoSmithKline", + "CollaboratorClass":"INDUSTRY" + } + ] + } + }, + "OversightModule":{ + "OversightHasDMC":"Yes" + }, + "DescriptionModule":{ + "BriefSummary":"The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART):\n\nWhether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as routine laboratory and clinical monitoring (LCM) for toxicity (haematology/biochemistry) and efficacy (CD4)?\n\nWhether induction with four drugs from two ART classes followed by maintenance with three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical outcome?\n\nTwo secondary objectives were to determine\n\nWhether changing from twice daily lamivudine+abacavir to once daily lamivudine+abacavir after 48 weeks on ART will have a similar outcome in terms of virological suppression and will result in improvements in adherence to ART?\nWhether stopping daily cotrimoxazole prophylaxis in children over 3 years of age who have been on ART for at least 96 weeks has a similar outcome in terms of hospitalisation or death as continuing daily cotrimoxazole?", + "DetailedDescription":"The ARROW (AntiRetroviral Research fOr Watoto) protocol describes an open-label randomised trial primarily evaluating two strategic approaches for management of antiretroviral therapy (ART) in 1200 symptomatic HIV-infected infants and children initiating ART following WHO guidelines in Uganda and Zimbabwe. The first strategy compares clinically driven monitoring (CDM) with laboratory plus clinical monitoring (LCM). In both groups, tests for toxicity (standard haematology and biochemistry panels) and efficacy (lymphocyte subsets including CD4 count) will be done every 12 weeks. In LCM, all results will be returned for patient management. In CDM, physicians may request results from routine haematology/biochemistry panels if needed for clinical management, but results will not be returned routinely, and lymphocyte subsets will never be returned. Extra laboratory tests may be requested outside of the scheduled visits at any time in either group (except for lymphocyte subsets in CDM). The second strategy compares a continuous WHO-recommended first-line ART three-drug two-class regimen, comprising two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) plus one Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), with induction with four drugs (two classes) for 36 weeks followed by maintenance with three drugs. After at least 36 and 96 weeks on ART respectively, two further randomisations will assess simplification strategies which could improve long-term ART adherence (i) once versus twice daily lamivudine+abacavir NRTI drugs (ii) stopping versus continuing daily cotrimoxazole prophylaxis." + }, + "ConditionsModule":{ + "ConditionList":{ + "Condition":[ + "Human Immunodeficiency Virus" + ] + }, + "KeywordList":{ + "Keyword":[ + "HIV", + "Africa", + "children", + "antiretroviral therapy", + "laboratory monitoring", + "toxicity", + "CD4", + "induction maintenance", + "cotrimoxazole", + "prophylaxis", + "abacavir", + "lamivudine", + "once daily" + ] + } + }, + "DesignModule":{ + "StudyType":"Interventional", + "PhaseList":{ + "Phase":[ + "Phase 4" + ] + }, + "DesignInfo":{ + "DesignAllocation":"Randomized", + "DesignInterventionModel":"Factorial Assignment", + "DesignPrimaryPurpose":"Treatment", + "DesignMaskingInfo":{ + "DesignMasking":"None (Open Label)" + } + }, + "EnrollmentInfo":{ + "EnrollmentCount":"1206", + "EnrollmentType":"Actual" + } + }, + "ArmsInterventionsModule":{ + "ArmGroupList":{ + "ArmGroup":[ + { + "ArmGroupLabel":"Clinically Driven Monitoring (CDM)", + "ArmGroupType":"Experimental", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Other: Clinically Driven Monitoring (CDM)" + ] + } + },{ + "ArmGroupLabel":"Laboratory plus Clinical Monitoring (LCM)", + "ArmGroupType":"Active Comparator", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Other: Laboratory plus Clinical Monitoring (LCM)" + ] + } + },{ + "ArmGroupLabel":"Arm A: abacavir (ABC)+lamivudine (3TC)+NNRTI", + "ArmGroupType":"Active Comparator", + "ArmGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: Arm A: ABC+3TC+NNRTI" + ] + } + },{ + "ArmGroupLabel":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance" + ] + } + },{ + "ArmGroupLabel":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance" + ] + } + },{ + "ArmGroupLabel":"Once-daily ABC+3TC", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: Once-daily ABC+3TC" + ] + } + },{ + "ArmGroupLabel":"Twice-daily ABC+3TC", + "ArmGroupType":"Active Comparator", + "ArmGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: Twice-daily ABC+3TC" + ] + } + },{ + "ArmGroupLabel":"Continued cotrimoxazole prophylaxis", + "ArmGroupType":"Active Comparator", + "ArmGroupDescription":"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Drug: Continued cotrimoxazole prophylaxis" + ] + } + },{ + "ArmGroupLabel":"Stopped cotrimoxazole prophylaxis", + "ArmGroupType":"Experimental", + "ArmGroupDescription":"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.", + "ArmGroupInterventionList":{ + "ArmGroupInterventionName":[ + "Other: Stopped cotrimoxazole prophylaxis" + ] + } + } + ] + }, + "InterventionList":{ + "Intervention":[ + { + "InterventionType":"Other", + "InterventionName":"Clinically Driven Monitoring (CDM)", + "InterventionDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Clinically Driven Monitoring (CDM)" + ] + } + },{ + "InterventionType":"Other", + "InterventionName":"Laboratory plus Clinical Monitoring (LCM)", + "InterventionDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Laboratory plus Clinical Monitoring (LCM)" + ] + } + },{ + "InterventionType":"Drug", + "InterventionName":"Arm A: ABC+3TC+NNRTI", + "InterventionDescription":"Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Arm A: abacavir (ABC)+lamivudine (3TC)+NNRTI" + ] + }, + "InterventionOtherNameList":{ + "InterventionOtherName":[ + "ABC: abacavir: Ziagen", + "3TC: lamivudine: Epivir", + "ABC+3TC co-formulated: Kivexa", + "NVP: nevirapine, Viramune", + "EFV: efavirenz, Sustiva" + ] + } + },{ + "InterventionType":"Drug", + "InterventionName":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance", + "InterventionDescription":"Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance" + ] + }, + "InterventionOtherNameList":{ + "InterventionOtherName":[ + "ZDV: zidovudine, azidothymidine, Retrovir", + "ABC: abacavir: Ziagen", + "3TC: lamivudine: Epivir", + "ZDV+3TC co-formulated: Combivir", + "ABC+3TC co-formulated: Kivexa", + "ZDV+ABC+3TC co-formulated: Trizivir", + "NVP: nevirapine, Viramune", + "EFV: efavirenz, Sustiva" + ] + } + },{ + "InterventionType":"Drug", + "InterventionName":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance", + "InterventionDescription":"Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance" + ] + }, + "InterventionOtherNameList":{ + "InterventionOtherName":[ + "ZDV: zidovudine, azidothymidine, Retrovir", + "ABC: abacavir: Ziagen", + "3TC: lamivudine: Epivir", + "ZDV+3TC co-formulated: Combivir", + "ABC+3TC co-formulated: Kivexa", + "ZDV+ABC+3TC co-formulated: Trizivir", + "NVP: nevirapine, Viramune", + "EFV: efavirenz, Sustiva" + ] + } + },{ + "InterventionType":"Drug", + "InterventionName":"Once-daily ABC+3TC", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Once-daily ABC+3TC" + ] + }, + "InterventionOtherNameList":{ + "InterventionOtherName":[ + "ABC: abacavir: Ziagen", + "3TC: lamivudine: Epivir", + "ABC+3TC co-formulated: Kivexa" + ] + } + },{ + "InterventionType":"Drug", + "InterventionName":"Twice-daily ABC+3TC", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Twice-daily ABC+3TC" + ] + }, + "InterventionOtherNameList":{ + "InterventionOtherName":[ + "ABC: abacavir: Ziagen", + "3TC: lamivudine: Epivir", + "ABC+3TC co-formulated: Kivexa" + ] + } + },{ + "InterventionType":"Drug", + "InterventionName":"Continued cotrimoxazole prophylaxis", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Continued cotrimoxazole prophylaxis" + ] + }, + "InterventionOtherNameList":{ + "InterventionOtherName":[ + "trimethoprim+sulfamethoxazole" + ] + } + },{ + "InterventionType":"Other", + "InterventionName":"Stopped cotrimoxazole prophylaxis", + "InterventionArmGroupLabelList":{ + "InterventionArmGroupLabel":[ + "Stopped cotrimoxazole prophylaxis" + ] + } + } + ] + } + }, + "OutcomesModule":{ + "PrimaryOutcomeList":{ + "PrimaryOutcome":[ + { + "PrimaryOutcomeMeasure":"LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death", + "PrimaryOutcomeDescription":"Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods", + "PrimaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "PrimaryOutcomeMeasure":"LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV", + "PrimaryOutcomeDescription":"Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods", + "PrimaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "PrimaryOutcomeMeasure":"Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation", + "PrimaryOutcomeTimeFrame":"Baseline, 72 weeks" + },{ + "PrimaryOutcomeMeasure":"Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation", + "PrimaryOutcomeTimeFrame":"Baseline, 144 weeks" + },{ + "PrimaryOutcomeMeasure":"Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV", + "PrimaryOutcomeDescription":"Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods", + "PrimaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "PrimaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation", + "PrimaryOutcomeDescription":"Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression.", + "PrimaryOutcomeTimeFrame":"48 weeks" + },{ + "PrimaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir", + "PrimaryOutcomeDescription":"Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods", + "PrimaryOutcomeTimeFrame":"Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)" + },{ + "PrimaryOutcomeMeasure":"Cotrimoxazole: New Hospitalisation or Death", + "PrimaryOutcomeDescription":"Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods", + "PrimaryOutcomeTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "PrimaryOutcomeMeasure":"Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV", + "PrimaryOutcomeDescription":"Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods", + "PrimaryOutcomeTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + } + ] + }, + "SecondaryOutcomeList":{ + "SecondaryOutcome":[ + { + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: All-cause Mortality", + "SecondaryOutcomeDescription":"Number of participants who died from any cause, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"Induction ART: New WHO Stage 4 Event or Death", + "SecondaryOutcomeDescription":"Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death", + "SecondaryOutcomeDescription":"Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death", + "SecondaryOutcomeDescription":"Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: Weight-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 4 years (maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: Height-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 4 years (maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 4 years (maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM: Change From Baseline in CD4% to Week 72", + "SecondaryOutcomeTimeFrame":"Baseline, week 72" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM: Change From Baseline in CD4% to Week 144", + "SecondaryOutcomeTimeFrame":"Baseline, week 144" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72", + "SecondaryOutcomeDescription":"Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "SecondaryOutcomeTimeFrame":"Baseline, week 72" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144", + "SecondaryOutcomeDescription":"Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "SecondaryOutcomeTimeFrame":"Baseline, week 144" + },{ + "SecondaryOutcomeMeasure":"CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline", + "SecondaryOutcomeDescription":"Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.", + "SecondaryOutcomeTimeFrame":"72 weeks" + },{ + "SecondaryOutcomeMeasure":"CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline", + "SecondaryOutcomeDescription":"Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.", + "SecondaryOutcomeTimeFrame":"144 weeks" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure", + "SecondaryOutcomeDescription":"Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART", + "SecondaryOutcomeDescription":"Number of participants with a new grade 3 or 4 adverse event definitely/probably or uncertainly related to ART, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV", + "SecondaryOutcomeDescription":"Number of participants with a new serious adverse events not solely related to HIV, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: New ART-modifying Adverse Event", + "SecondaryOutcomeDescription":"Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)", + "SecondaryOutcomeDescription":"Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.", + "SecondaryOutcomeTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation", + "SecondaryOutcomeDescription":"Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.", + "SecondaryOutcomeTimeFrame":"96 weeks" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48", + "SecondaryOutcomeTimeFrame":"Randomisation to once vs twice daily, week 48" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72", + "SecondaryOutcomeTimeFrame":"Baseline, week 72" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96", + "SecondaryOutcomeTimeFrame":"Randomisation to once vs twice daily, week 96" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48", + "SecondaryOutcomeDescription":"Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "SecondaryOutcomeTimeFrame":"Randomisation to once vs twice daily, week 48" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72", + "SecondaryOutcomeDescription":"All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured", + "SecondaryOutcomeTimeFrame":"Baseline, week 72" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96", + "SecondaryOutcomeDescription":"All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured", + "SecondaryOutcomeTimeFrame":"Randomisation to once vs twice daily, week 96" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality", + "SecondaryOutcomeDescription":"Number of participants who died, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death", + "SecondaryOutcomeDescription":"Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death", + "SecondaryOutcomeDescription":"Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV", + "SecondaryOutcomeDescription":"Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV", + "SecondaryOutcomeDescription":"Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks", + "SecondaryOutcomeDescription":"Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks.", + "SecondaryOutcomeTimeFrame":"48 weeks after randomization to once- versus twice-daily" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks", + "SecondaryOutcomeDescription":"Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks.", + "SecondaryOutcomeTimeFrame":"96 weeks after randomization to once- versus twice-daily" + },{ + "SecondaryOutcomeMeasure":"Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)", + "SecondaryOutcomeDescription":"Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.", + "SecondaryOutcomeTimeFrame":"Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: New Clinical and Diagnostic Positive Malaria", + "SecondaryOutcomeDescription":"Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT)", + "SecondaryOutcomeTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: New Severe Pneumonia", + "SecondaryOutcomeDescription":"Number of participants with a new severe pneumonia, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: New WHO Stage 3 or 4 Event or Death", + "SecondaryOutcomeDescription":"Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea", + "SecondaryOutcomeDescription":"Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: New WHO Stage 4 Event or Death", + "SecondaryOutcomeDescription":"Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: All-cause Mortality", + "SecondaryOutcomeDescription":"Number of participants who died, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: Weight-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: Height-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: Body Mass Index-for-age Z-score", + "SecondaryOutcomeDescription":"Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "SecondaryOutcomeTimeFrame":"Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: Change From Baseline in CD4% to Week 72", + "SecondaryOutcomeTimeFrame":"Baseline, week 72" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72", + "SecondaryOutcomeDescription":"Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "SecondaryOutcomeTimeFrame":"Baseline, week 72" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV", + "SecondaryOutcomeDescription":"Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods", + "SecondaryOutcomeTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + },{ + "SecondaryOutcomeMeasure":"Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)", + "SecondaryOutcomeDescription":"Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.", + "SecondaryOutcomeTimeFrame":"Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)" + } + ] + } + }, + "EligibilityModule":{ + "EligibilityCriteria":"For initial randomisation to CDM vs LCM, and to ART induction strategy:\n\nInclusion Criteria:\n\nChildren should have an adult carer in the household who is either:\n\nparticipating in the DART trial OR\nbeing treated with ART OR\nHIV positive but not yet needing treatment but with access to a treatment programme when ART is required OR\nHIV negative. Children of DART participants should have first priority on any available remaining slots to enter ARROW.\nParents or guardians, and children where appropriate according to age and knowledge of HIV status, must be willing and able to give informed consent for randomisation to CDM or LCM and to first-line ART strategy.\n\nParticipants must have a confirmed documented diagnosis of HIV-1 infection:\n\nFor children aged under 18 months: two separate peripheral blood specimens from different days, both results being positive with HIV-DNA polymerase chain reaction (PCR).\nFor children aged 18 months or over: antibody positive serology by ELISA test (confirmed by licensed second ELISA or Western Blot) or WHO approved rapid test (performed in series) both on the same sample. Any child previously tested at another clinic should have a repeat test at an ARROW screening laboratory to confirm their status.\nAge 3 months to 17 years (13-17 years to be capped at 10%)\nART naïve (except for exposure to perinatal ART for the prevention of mother-to-child HIV transmission).\n\nMeeting criteria for requiring ART according to WHO stage and CD4 percent or count:\n\nWHO paediatric clinical stage IV disease: treat regardless of CD4 percent or count\n\nWHO paediatric clinical stage III disease:\n\n<12 months: treat all\n>12 months: treat all children irrespective of the CD4 percent or count; however, in children aged > 12 months with tuberculosis, lymphocytic interstitial pneumonia (LIP), oral hairy leukoplakia (OHP) or thrombocytopenia (low platelet count treat) be guided by CD4 cell assays (see below).\n\nWHO paediatric clinical stage II or I disease: treat guided by CD4 percent or count\n\nCD4%<25% for infants <12 months;\nCD4%<20% for children 1-<3 years;\nCD4% <15% for children 3-<5years;\nCD4% <15% for children > 5years (consideration should also be taken of the CD4 count. A CD4 count <200 cells/mm3 can be used to guide starting ART and CD4 should generally be <350 cells/mm3.)\n\nExclusion Criteria:\n\nCannot, or unlikely to attend regularly (e.g. usual residence too far from study centre)\nLikelihood of poor adherence\nPresence of acute infection (e.g. malaria, helminthiasis, acute hepatitis, acute pneumonia, septicaemia, meningitis). Children may be admitted after recovery of an acute infection. Children with chronic lung disease, including recurrent respiratory infections, are eligible. Children with tuberculosis (TB) will not be enrolled while on the intensive phase of anti-tuberculosis therapy, but should be re-evaluated after the intensive phase and a decision made then about starting ART (see 4 below)\n\nIn receipt of medication contraindicated by ART\n\nchildren under three years of age receiving anti-tuberculosis therapy should not be enrolled (as they will have to receive nevirapine).\non chemotherapy for malignancy\n\nLaboratory abnormalities which are a contra-indication for the child to start ART (haemoglobin <8.5g/dL; neutrophils <0.50x109/L; aspartate transaminase (AST) or alanine transaminase (ALT) >5 x the upper limit of normal (ULN); grade 3 renal dysfunction - creatinine >1.9 x ULN).\n\nN.B. causes of anaemia, such as concurrent bacterial infection, malaria, helminthiasis and/or malnutrition should be investigated, and treatment for anaemia and its causes commenced prior to re-screening for eligibility.\n\nBeing pregnant or breast-feeding an infant\nPerinatal exposure to nevirapine (either through prevention of mother-to-child transmission (pMTCT) or breastfeeding) for children aged 3 - 6 months only\n\nEligibility criteria for the secondary randomisation to once vs twice daily lamivudine+abacavir Inclusion criteria\n\nParticipating in ARROW\nOn ART for at least 36 weeks\nCurrently taking lamivudine+abacavir twice daily as part of their ART regimen and expected to stay on these two drugs for at least the next 12 weeks\n\nParents or guardians, and children where appropriate according to age and knowledge of HIV status, must be willing and able to give informed consent for randomisation to once or twice daily lamivudine+abacavir\n\nExclusion criteria\n\nLikely to switch to second-line therapy in the next 12 weeks\n\nEligibility criteria for the secondary randomisation to stop or continue cotrimoxazole prophylaxis randomisation Inclusion criteria\n\nParticipating in ARROW\nAged at least 3 years\nInitiated ART at least 96 weeks previously, and received at least 96 weeks of ART allowing for any interruptions in ART\nCurrently prescribed daily cotrimoxazole as primary prophylaxis\nParents or guardians, and children where appropriate according to age and knowledge of HIV status, must be willing and able to give informed consent for randomisation to stop or continue daily cotrimoxazole prophylaxis\n\nIf living in a malaria endemic area, has an insecticide treated bednet and prepared to use this for the child.\n\nExclusion criteria\n\nPrevious diagnosis of Pneumocystis jiroveci pneumonia (cotrimoxazole is secondary prophylaxis and should not be discontinued)", + "HealthyVolunteers":"No", + "Gender":"All", + "MinimumAge":"3 Months", + "MaximumAge":"17 Years", + "StdAgeList":{ + "StdAge":[ + "Child" + ] + } + }, + "ContactsLocationsModule":{ + "OverallOfficialList":{ + "OverallOfficial":[ + { + "OverallOfficialName":"Diana M Gibb, MD", + "OverallOfficialAffiliation":"Medical Research Council", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Peter Mugyenyi, PhD", + "OverallOfficialAffiliation":"Joint Clinical Research Centre, Kampala, Uganda", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Kusum Nathoo, PhD", + "OverallOfficialAffiliation":"University of Zimbabwe, Harare, Zimbabwe", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Adeodata Kekitiinwa, MD", + "OverallOfficialAffiliation":"Baylor College of Medicine Children's Foundation, Mulago, Uganda", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Paula Munderi, MBChB", + "OverallOfficialAffiliation":"MRC /UVRI Uganda Research Unit on AIDS, Entebbe, Uganda", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Victor Musiime, PhD", + "OverallOfficialAffiliation":"Joint Clinical Research Centre, Kampala, Uganda", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Mutsa F Bwakura-Dangarembizi, MBChB", + "OverallOfficialAffiliation":"University of Zimbabwe, Harare, Zimbabwe", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Philippa Musoke, PhD", + "OverallOfficialAffiliation":"Baylor College of Medicine Children's Foundation, Mulago, Uganda", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Sabrina Bakeera-Kitaka, MBChB", + "OverallOfficialAffiliation":"Baylor College of Medicine Children's Foundation, Mulago, Uganda", + "OverallOfficialRole":"Principal Investigator" + },{ + "OverallOfficialName":"Patricia Nahirya-Ntege, MBChB", + "OverallOfficialAffiliation":"MRC/UVRI and LSHTM Uganda Research Unit", + "OverallOfficialRole":"Principal Investigator" + } + ] + }, + "LocationList":{ + "Location":[ + { + "LocationFacility":"MRC /UVRI Uganda Research Unit on AIDS", + "LocationCity":"Entebbe", + "LocationCountry":"Uganda" + },{ + "LocationFacility":"Joint Clinical Research Centre", + "LocationCity":"Kampala", + "LocationCountry":"Uganda" + },{ + "LocationFacility":"Baylor College of Medicine Children's Foundation", + "LocationCity":"Mulago", + "LocationCountry":"Uganda" + },{ + "LocationFacility":"University of Zimbabwe Medical School", + "LocationCity":"Harare", + "LocationCountry":"Zimbabwe" + } + ] + } + }, + "ReferencesModule":{ + "ReferenceList":{ + "Reference":[ + { + "ReferencePMID":"23473847", + "ReferenceType":"result", + "ReferenceCitation":"ARROW Trial team. Routine versus clinically driven laboratory monitoring and first-line antiretroviral therapy strategies in African children with HIV (ARROW): a 5-year open-label randomised factorial trial. Lancet. 2013 Apr 20;381(9875):1391-1403. doi: 10.1016/S0140-6736(12)62198-9. Epub 2013 Mar 7." + },{ + "ReferencePMID":"24382064", + "ReferenceType":"result", + "ReferenceCitation":"Bwakura-Dangarembizi M, Kendall L, Bakeera-Kitaka S, Nahirya-Ntege P, Keishanyu R, Nathoo K, Spyer MJ, Kekitiinwa A, Lutaakome J, Mhute T, Kasirye P, Munderi P, Musiime V, Gibb DM, Walker AS, Prendergast AJ. A randomized trial of prolonged co-trimoxazole in HIV-infected children in Africa. N Engl J Med. 2014 Jan 2;370(1):41-53. doi: 10.1056/NEJMoa1214901. Erratum In: N Engl J Med. 2014 Jan 30;370(5):488. Dosage error in article text." + },{ + "ReferencePMID":"27064996", + "ReferenceType":"derived", + "ReferenceCitation":"Musiime V, Kasirye P, Naidoo-James B, Nahirya-Ntege P, Mhute T, Cook A, Mugarura L, Munjoma M, Thoofer NK, Ndashimye E, Nankya I, Spyer MJ, Thomason MJ, Snowden W, Gibb DM, Walker AS; ARROW Trial Team. Once vs twice-daily abacavir and lamivudine in African children. AIDS. 2016 Jul 17;30(11):1761-70. doi: 10.1097/QAD.0000000000001116." + } + ] + }, + "SeeAlsoLinkList":{ + "SeeAlsoLink":[ + { + "SeeAlsoLinkLabel":"main ARROW trial webpage", + "SeeAlsoLinkURL":"http://www.arrowtrial.org/" + } + ] + } + } + }, + "ResultsSection":{ + "ParticipantFlowModule":{ + "FlowPreAssignmentDetails":"There were two additional nested substudy randomizations after initial trial enrolment (see inclusion/exclusion criteria for eligibility). From 8/2009 to 6/2010, eligible children were randomized to once vs twice daily abacavir+lamivudine. From 9/2009 to 2/2011, eligible children were randomized to stop vs continue cotrimoxazole prophylaxis.", + "FlowRecruitmentDetails":"All recruited children (n=1206) were randomly assigned to CDM vs LCM and the three different induction ART strategies at enrolment (3/2007-11/2008). This was a factorial randomisation meaning that the children were effectively randomized into 6 parallel groups. Baseline characteristics are presented below separately for each initial randomization.", + "FlowGroupList":{ + "FlowGroup":[ + { + "FlowGroupId":"FG000", + "FlowGroupTitle":"Clinically Driven Monitoring (CDM)", + "FlowGroupDescription":"Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "FlowGroupId":"FG001", + "FlowGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "FlowGroupDescription":"Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "FlowGroupId":"FG002", + "FlowGroupTitle":"Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI", + "FlowGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "FlowGroupId":"FG003", + "FlowGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "FlowGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "FlowGroupId":"FG004", + "FlowGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "FlowGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "FlowGroupId":"FG005", + "FlowGroupTitle":"Once-daily ABC+3TC", + "FlowGroupDescription":"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO\n\nOnce-daily ABC+3TC" + },{ + "FlowGroupId":"FG006", + "FlowGroupTitle":"Twice-daily ABC+3TC", + "FlowGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO\n\nTwice-daily ABC+3TC" + },{ + "FlowGroupId":"FG007", + "FlowGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "FlowGroupDescription":"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole\n\nContinued cotrimoxazole prophylaxis" + },{ + "FlowGroupId":"FG008", + "FlowGroupTitle":"Stopped Cotrimoxazole Prophylaxis", + "FlowGroupDescription":"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.\n\nStopped cotrimoxazole prophylaxis" + } + ] + }, + "FlowPeriodList":{ + "FlowPeriod":[ + { + "FlowPeriodTitle":"Initial Enrolment: CDM vs LCM", + "FlowMilestoneList":{ + "FlowMilestone":[ + { + "FlowMilestoneType":"STARTED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementComment":"Factorial randomization at enrolment: Number of eligible children randomized to this group in ARROW", + "FlowAchievementNumSubjects":"606" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementComment":"Factorial randomization at enrolment: Number of eligible children randomized to this group in ARROW", + "FlowAchievementNumSubjects":"600" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementComment":"Factorial randomization at enrolment: Number of eligible children randomized to this group in ARROW", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementComment":"Factorial randomization at enrolment: Number of eligible children randomized to this group in ARROW", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementComment":"Factorial randomization at enrolment: Number of eligible children randomized to this group in ARROW", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementComment":"Secondary partial factorial randomization: Only a subset of ARROW children were eligible", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementComment":"Secondary partial factorial randomization: Only a subset of ARROW children were eligible", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementComment":"Secondary partial factorial randomization: Only a subset of ARROW children were eligible", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementComment":"Secondary partial factorial randomization: Only a subset of ARROW children were eligible", + "FlowAchievementNumSubjects":"0" + } + ] + } + },{ + "FlowMilestoneType":"COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"606" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"600" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + },{ + "FlowMilestoneType":"NOT COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + } + ] + } + },{ + "FlowPeriodTitle":"Initial Enrolment: Induction ART", + "FlowMilestoneList":{ + "FlowMilestone":[ + { + "FlowMilestoneType":"STARTED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"397" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"404" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"405" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + },{ + "FlowMilestoneType":"COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"397" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"404" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"405" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + },{ + "FlowMilestoneType":"NOT COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + } + ] + } + },{ + "FlowPeriodTitle":"Subsequent Once vs Twice Daily ABC+3TC", + "FlowMilestoneList":{ + "FlowMilestone":[ + { + "FlowMilestoneType":"STARTED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"336" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"333" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + },{ + "FlowMilestoneType":"COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"336" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"333" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + },{ + "FlowMilestoneType":"NOT COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + } + ] + } + },{ + "FlowPeriodTitle":"Subsequent Cotrimoxazole Randomization", + "FlowMilestoneList":{ + "FlowMilestone":[ + { + "FlowMilestoneType":"STARTED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"376" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"382" + } + ] + } + },{ + "FlowMilestoneType":"COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"376" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"382" + } + ] + } + },{ + "FlowMilestoneType":"NOT COMPLETED", + "FlowAchievementList":{ + "FlowAchievement":[ + { + "FlowAchievementGroupId":"FG000", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG001", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG002", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG003", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG004", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG005", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG006", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG007", + "FlowAchievementNumSubjects":"0" + },{ + "FlowAchievementGroupId":"FG008", + "FlowAchievementNumSubjects":"0" + } + ] + } + } + ] + } + } + ] + } + }, + "BaselineCharacteristicsModule":{ + "BaselinePopulationDescription":"All participants who were randomized were included except those who were randomised in error (main enrollment: 1 child HIV-uninfected, 2 on main phase of tuberculosis treatment; cotrimoxazole secondary randomization: 2 children receiving dapsone prophylaxis not cotrimoxazole).", + "BaselineGroupList":{ + "BaselineGroup":[ + { + "BaselineGroupId":"BG000", + "BaselineGroupTitle":"Clinically Driven Monitoring (CDM)", + "BaselineGroupDescription":"Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "BaselineGroupId":"BG001", + "BaselineGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "BaselineGroupDescription":"Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "BaselineGroupId":"BG002", + "BaselineGroupTitle":"Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI", + "BaselineGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "BaselineGroupId":"BG003", + "BaselineGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "BaselineGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "BaselineGroupId":"BG004", + "BaselineGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "BaselineGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "BaselineGroupId":"BG005", + "BaselineGroupTitle":"Once-daily ABC+3TC", + "BaselineGroupDescription":"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO\n\nOnce-daily ABC+3TC" + },{ + "BaselineGroupId":"BG006", + "BaselineGroupTitle":"Twice-daily ABC+3TC", + "BaselineGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO\n\nTwice-daily ABC+3TC" + },{ + "BaselineGroupId":"BG007", + "BaselineGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "BaselineGroupDescription":"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole\n\nContinued cotrimoxazole prophylaxis" + },{ + "BaselineGroupId":"BG008", + "BaselineGroupTitle":"Stopped Cotrimoxazole Prophylaxis", + "BaselineGroupDescription":"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.\n\nStopped cotrimoxazole prophylaxis" + },{ + "BaselineGroupId":"BG009", + "BaselineGroupTitle":"Total", + "BaselineGroupDescription":"Total of all reporting groups" + } + ] + }, + "BaselineDenomList":{ + "BaselineDenom":[ + { + "BaselineDenomUnits":"Participants", + "BaselineDenomCountList":{ + "BaselineDenomCount":[ + { + "BaselineDenomCountGroupId":"BG000", + "BaselineDenomCountValue":"606" + },{ + "BaselineDenomCountGroupId":"BG001", + "BaselineDenomCountValue":"600" + },{ + "BaselineDenomCountGroupId":"BG002", + "BaselineDenomCountValue":"397" + },{ + "BaselineDenomCountGroupId":"BG003", + "BaselineDenomCountValue":"404" + },{ + "BaselineDenomCountGroupId":"BG004", + "BaselineDenomCountValue":"405" + },{ + "BaselineDenomCountGroupId":"BG005", + "BaselineDenomCountValue":"336" + },{ + "BaselineDenomCountGroupId":"BG006", + "BaselineDenomCountValue":"333" + },{ + "BaselineDenomCountGroupId":"BG007", + "BaselineDenomCountValue":"376" + },{ + "BaselineDenomCountGroupId":"BG008", + "BaselineDenomCountValue":"382" + },{ + "BaselineDenomCountGroupId":"BG009", + "BaselineDenomCountValue":"3839" + } + ] + } + } + ] + }, + "BaselineMeasureList":{ + "BaselineMeasure":[ + { + "BaselineMeasureTitle":"Age, Continuous", + "BaselineMeasureDescription":"Age at trial enrollment (antiretroviral therapy initiation).", + "BaselineMeasureParamType":"Median", + "BaselineMeasureDispersionType":"Inter-Quartile Range", + "BaselineMeasureUnitOfMeasure":"years", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"5.9", + "BaselineMeasurementLowerLimit":"2.2", + "BaselineMeasurementUpperLimit":"9.2" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"6.0", + "BaselineMeasurementLowerLimit":"2.6", + "BaselineMeasurementUpperLimit":"9.4" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"6.0", + "BaselineMeasurementLowerLimit":"2.4", + "BaselineMeasurementUpperLimit":"9.3" + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Age, Customized", + "BaselineMeasureDescription":"Age at trial enrollment (antiretroviral therapy initiation).", + "BaselineMeasureParamType":"Number", + "BaselineMeasureUnitOfMeasure":"participants", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineClassTitle":"< 3 years", + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"197" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"173" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Total not calculated because data are not available (NA) in one or more arms." + } + ] + } + } + ] + } + },{ + "BaselineClassTitle":"3 years or older", + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"409" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"427" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Total not calculated because data are not available (NA) in one or more arms." + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Sex: Female, Male", + "BaselineMeasureParamType":"Count of Participants", + "BaselineMeasureUnitOfMeasure":"Participants", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineCategoryTitle":"Female", + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"308" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"302" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Total not calculated because data are not available (NA) in one or more arms." + } + ] + } + },{ + "BaselineCategoryTitle":"Male", + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"298" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"298" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Total not calculated because data are not available (NA) in one or more arms." + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Region of Enrollment", + "BaselineMeasureDescription":"Region of enrollment at trial enrollment (antiretroviral therapy initiation).", + "BaselineMeasureParamType":"Number", + "BaselineMeasureUnitOfMeasure":"participants", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineClassTitle":"Uganda", + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"405" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"401" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparisonDifferent randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Total not calculated because data are not available (NA) in one or more arms." + } + ] + } + } + ] + } + },{ + "BaselineClassTitle":"Zimbabwe", + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"201" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"199" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementComment":"Total not calculated because data are not available (NA) in one or more arms." + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Age, continuous: Period 2 (trial enrollment, induction ART)", + "BaselineMeasureDescription":"Age at trial enrollment (antiretroviral therapy initiation).", + "BaselineMeasureParamType":"Median", + "BaselineMeasureDispersionType":"Inter-Quartile Range", + "BaselineMeasureUnitOfMeasure":"years", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"6.1", + "BaselineMeasurementLowerLimit":"2.4", + "BaselineMeasurementUpperLimit":"9.3" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"6.2", + "BaselineMeasurementLowerLimit":"2.5", + "BaselineMeasurementUpperLimit":"9.4" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"5.7", + "BaselineMeasurementLowerLimit":"2.3", + "BaselineMeasurementUpperLimit":"9.3" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"6.0", + "BaselineMeasurementLowerLimit":"2.4", + "BaselineMeasurementUpperLimit":"9.4" + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Age, continuous: Period 3 (randomization to once vs twice daily ABC+3TC)", + "BaselineMeasureDescription":"Age at the time of the secondary randomization to once versus twice daily abacavir+lamivudine (in those children eligible and randomized).", + "BaselineMeasureParamType":"Median", + "BaselineMeasureDispersionType":"Inter-Quartile Range", + "BaselineMeasureUnitOfMeasure":"years", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"5.9", + "BaselineMeasurementLowerLimit":"3.8", + "BaselineMeasurementUpperLimit":"8.6" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"5.1", + "BaselineMeasurementLowerLimit":"3.6", + "BaselineMeasurementUpperLimit":"8.3" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"5.5", + "BaselineMeasurementLowerLimit":"3.7", + "BaselineMeasurementUpperLimit":"8.5" + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Age, continuous: Period 4 (randomization to stop versus continue cotrimoxazole)", + "BaselineMeasureDescription":"Age at the time of the secondary randomization to stop versus continue cotrimoxazole prophylaxis (in those children eligible and randomized).", + "BaselineMeasureParamType":"Median", + "BaselineMeasureDispersionType":"Inter-Quartile Range", + "BaselineMeasureUnitOfMeasure":"years", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"7.5", + "BaselineMeasurementLowerLimit":"4.6", + "BaselineMeasurementUpperLimit":"11.1" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"8.3", + "BaselineMeasurementLowerLimit":"4.5", + "BaselineMeasurementUpperLimit":"11.0" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"7.9", + 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"BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"33.0", + "BaselineMeasurementLowerLimit":"28.0", + "BaselineMeasurementUpperLimit":"39.0" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"33.0", + "BaselineMeasurementLowerLimit":"27.0", + "BaselineMeasurementUpperLimit":"39.0" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"33.0", + "BaselineMeasurementLowerLimit":"28.0", + "BaselineMeasurementUpperLimit":"39.0" + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"CD4 T cell percentage: Period 4 (randomization to stop versus continue cotrimoxazole)", + "BaselineMeasureDescription":"CD4 T cell percentage at the time of the secondary randomization to stop versus continue cotrimoxazole prophylaxis (in those children eligible and randomized).", + "BaselineMeasureParamType":"Median", + "BaselineMeasureDispersionType":"Inter-Quartile Range", + "BaselineMeasureUnitOfMeasure":"percentage of total lymphocytes", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + 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"BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"2.1", + "BaselineMeasurementLowerLimit":"1.6", + "BaselineMeasurementUpperLimit":"3.2" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"2.1", + "BaselineMeasurementLowerLimit":"1.8", + "BaselineMeasurementUpperLimit":"3.2" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"2.1", + "BaselineMeasurementLowerLimit":"1.6", + "BaselineMeasurementUpperLimit":"3.2" + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Weight-for-age Z-score: Period 1 (trial enrollment, CDM vs LCM)", + "BaselineMeasureDescription":"Weight-for-age Z-score at trial enrollment (antiretroviral therapy initiation).", + "BaselineMeasureParamType":"Median", + "BaselineMeasureDispersionType":"Inter-Quartile Range", + "BaselineMeasureUnitOfMeasure":"Z-score", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"-2.3", + "BaselineMeasurementLowerLimit":"-3.4", + "BaselineMeasurementUpperLimit":"-1.3" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"-2.2", + "BaselineMeasurementLowerLimit":"-3.3", + "BaselineMeasurementUpperLimit":"-1.3" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + 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"BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"-1.4", + "BaselineMeasurementLowerLimit":"-2.0", + "BaselineMeasurementUpperLimit":"-0.7" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"-1.3", + "BaselineMeasurementLowerLimit":"-2.0", + "BaselineMeasurementUpperLimit":"-0.6" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"-1.4", + "BaselineMeasurementLowerLimit":"-2.0", + "BaselineMeasurementUpperLimit":"-0.7" + } + ] + } + } + ] + } + } + ] + } + },{ + "BaselineMeasureTitle":"Weight-for-age Z-score: Period 4 (randomization to stop versus continue cotrimoxazole)", + "BaselineMeasureDescription":"Weight-for-age Z-score at the time of the secondary randomization to stop versus continue cotrimoxazole prophylaxis (in those children eligible and randomized).", + "BaselineMeasureParamType":"Median", + "BaselineMeasureDispersionType":"Inter-Quartile Range", + "BaselineMeasureUnitOfMeasure":"Z-score", + "BaselineClassList":{ + "BaselineClass":[ + { + "BaselineCategoryList":{ + "BaselineCategory":[ + { + "BaselineMeasurementList":{ + "BaselineMeasurement":[ + { + "BaselineMeasurementGroupId":"BG000", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG001", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG002", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG003", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG004", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG005", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG006", + "BaselineMeasurementValue":"NA", + "BaselineMeasurementLowerLimit":"NA", + "BaselineMeasurementUpperLimit":"NA", + "BaselineMeasurementComment":"Different randomized comparison" + },{ + "BaselineMeasurementGroupId":"BG007", + "BaselineMeasurementValue":"-1.3", + "BaselineMeasurementLowerLimit":"-1.9", + "BaselineMeasurementUpperLimit":"-0.6" + },{ + "BaselineMeasurementGroupId":"BG008", + "BaselineMeasurementValue":"-1.3", + "BaselineMeasurementLowerLimit":"-1.9", + "BaselineMeasurementUpperLimit":"-0.7" + },{ + "BaselineMeasurementGroupId":"BG009", + "BaselineMeasurementValue":"-1.3", + "BaselineMeasurementLowerLimit":"-1.9", + "BaselineMeasurementUpperLimit":"-0.6" + } + ] + } + } + ] + } + } + ] + } + } + ] + } + }, + "OutcomeMeasuresModule":{ + "OutcomeMeasureList":{ + "OutcomeMeasure":[ + { + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death", + "OutcomeMeasureDescription":"Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods", + "OutcomeMeasurePopulationDescription":"All randomized participants (time-to-event)", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"47" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"39" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"Yes", + "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", + "OutcomeAnalysisNonInferiorityComment":"Upper 95% confidence interval for the hazard ratio was 1.64, see other analysis for this endpoint for details", + "OutcomeAnalysisPValue":"0.59", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.13", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.73", + "OutcomeAnalysisCIUpperLimit":"1.73", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Assumptions:\n\ncontrol group (LCM) event rate 3% per year\nrates are reduced to 2% per year in the best of the induction-maintenance arms leading to an overall rate of progression to new WHO stage 4 or death of 2.5%\nrecruitment is over 1.5 years and follow-up for a minimum further 3.5 years.\ncumulative loss to follow-up is 10% at 5 years. See below for rest of sample size as this box is not big enough.", + "OutcomeAnalysisTestedNonInferiority":"Yes", + "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", + "OutcomeAnalysisNonInferiorityComment":"With assumptions detailed above, >90% power and one-sided alpha=0.05, 1160 children would be required to exclude an increase in progression rate of 1.6% from 2.5% to 4.1% per year in the CDM arm (upper 95% confidence limit of LCM: CDM hazard ratio 1.64).", + "OutcomeAnalysisPValue":"0.43", + "OutcomeAnalysisStatisticalMethod":"Comparison of poisson rates", + "OutcomeAnalysisStatisticalComment":"Statistical analysis plan specified that p-value was to be calculated from the log-rank test, so not provided for the risk difference", + "OutcomeAnalysisParamType":"Risk Difference (RD)", + "OutcomeAnalysisParamValue":"0.32", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-0.47", + "OutcomeAnalysisCIUpperLimit":"1.12", + "OutcomeAnalysisEstimateComment":"Difference is CDM minus LCM" + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV", + "OutcomeMeasureDescription":"Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"283" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"282" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.83", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.98", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.83", + "OutcomeAnalysisCIUpperLimit":"1.16", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation", + "OutcomeMeasurePopulationDescription":"All participants alive at 72 weeks with CD4 measured (completeness in those in follow-up was 96.6%).", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Error", + "OutcomeMeasureUnitOfMeasure":"percentage of total lymphocytes", + "OutcomeMeasureTimeFrame":"Baseline, 72 weeks", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"374" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"388" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"374" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"16.4", + "OutcomeMeasurementSpread":"0.45" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"17.1", + "OutcomeMeasurementSpread":"0.43" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"17.3", + "OutcomeMeasurementSpread":"0.41" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001", + "OG002" + ] + }, + "OutcomeAnalysisGroupDescription":"Assuming a standard deviation for the change in CD4 percentage from baseline to 72 weeks of 10% (slightly higher than that observed in the PENTA 5 trial) 1200 children would provide at least 80% power to detect a difference in change in CD4% from baseline of more than 2.5% across the 3 groups (F-test with 2-sided alpha=0.05) assuming 20% missing data (loss to follow-up during the first year plus failure to attend the week 72 visit/missing sample).", + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.33", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4% (95% completeness)", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Error", + "OutcomeMeasureUnitOfMeasure":"percentage of total lymphocytes", + "OutcomeMeasureTimeFrame":"Baseline, 144 weeks", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"371" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"387" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"378" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"19.8", + "OutcomeMeasurementSpread":"0.44" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"19.6", + "OutcomeMeasurementSpread":"0.49" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"19.2", + "OutcomeMeasurementSpread":"0.46" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001", + "OG002" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.69", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV", + "OutcomeMeasureDescription":"Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"157" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"190" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"218" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001", + "OG002" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.0001", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.01", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.32", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.07", + "OutcomeAnalysisCIUpperLimit":"1.63", + "OutcomeAnalysisEstimateComment":"HR is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG002" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"<0.001", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.58", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.29", + "OutcomeAnalysisCIUpperLimit":"1.94" + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation", + "OutcomeMeasureDescription":"Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression.", + "OutcomeMeasurePopulationDescription":"All randomized participants with VL result from stored plasma specimen (available for 661/669, 99%, randomized participants)", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"48 weeks", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"330" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"331" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"236" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"242" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"Yes", + "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", + "OutcomeAnalysisNonInferiorityComment":"631 children would be required to exclude a 12% lower suppression rate in the once daily group with at least 90% power and two-sided alpha=0.05 (lower 95% confidence limit of difference between once and twice daily -12%, the non-inferiority margin). 630 children retains at least 80% (rather than 90%) power to exclude a 10% (rather than 12%) lower suppression rate in the once daily group with one-sided alpha=0.05 (lower 90% confidence limit of difference between once and twice daily -10%).", + "OutcomeAnalysisPValue":"0.65", + "OutcomeAnalysisStatisticalMethod":"Chi-squared", + "OutcomeAnalysisParamType":"Risk Difference (RD)", + "OutcomeAnalysisParamValue":"-1.6", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-8.4", + "OutcomeAnalysisCIUpperLimit":"5.2", + "OutcomeAnalysisEstimateComment":"Difference in suppression <80 copies/ml in once-daily minus twice-daily" + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir", + "OutcomeMeasureDescription":"Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"336" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"333" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"0" + } + ] + } + } + ] + } + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"Cotrimoxazole: New Hospitalisation or Death", + "OutcomeMeasureDescription":"Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "OutcomeGroupDescription":"Other Names:\n\ntrimethoprim+sulfamethoxazole" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Stopped Cotrimoxazole Prophylaxis" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"376" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"382" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"48" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"72" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Assumptions\n\n5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year\nrecruitment starts 1 July 2009 with 10% children (those already on ART for >96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.\ncumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough", + "OutcomeAnalysisTestedNonInferiority":"Yes", + "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", + "OutcomeAnalysisNonInferiorityComment":"With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).", + "OutcomeAnalysisPValue":"0.007", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.64", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.14", + "OutcomeAnalysisCIUpperLimit":"2.37", + "OutcomeAnalysisEstimateComment":"Hazard ratio is stop vs continue." + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisGroupDescription":"Assumptions\n\n5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year\nrecruitment starts 1 July 2009 with 10% children (those already on ART for >96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.\ncumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough.", + "OutcomeAnalysisTestedNonInferiority":"Yes", + "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", + "OutcomeAnalysisNonInferiorityComment":"With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).", + "OutcomeAnalysisPValue":"0.006", + "OutcomeAnalysisStatisticalMethod":"Poisson regression for risk difference", + "OutcomeAnalysisParamType":"Risk Difference (RD)", + "OutcomeAnalysisParamValue":"4.0", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.8", + "OutcomeAnalysisCIUpperLimit":"7.2", + "OutcomeAnalysisEstimateComment":"Risk difference is stop vs continue." + } + ] + } + },{ + "OutcomeMeasureType":"Primary", + "OutcomeMeasureTitle":"Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV", + "OutcomeMeasureDescription":"Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "OutcomeGroupDescription":"Other Names:\n\ntrimethoprim+sulfamethoxazole" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Stopped Cotrimoxazole Prophylaxis" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"376" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"382" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"55" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"64" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.33", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.20", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.83", + "OutcomeAnalysisCIUpperLimit":"1.72", + "OutcomeAnalysisEstimateComment":"Hazard ratio is stop vs continue." + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: All-cause Mortality", + "OutcomeMeasureDescription":"Number of participants who died from any cause, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"25" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"29" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"20" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"14" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"20" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.45", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.84", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.49", + "OutcomeAnalysisCIUpperLimit":"1.44", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.43", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.23", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.66", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.33", + "OutcomeAnalysisCIUpperLimit":"1.31", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.93", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.97", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.52", + "OutcomeAnalysisCIUpperLimit":"1.81", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm C vs A" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Induction ART: New WHO Stage 4 Event or Death", + "OutcomeMeasureDescription":"Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"30" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"28" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"28" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001", + "OG002" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.89", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.64", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.89", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.53", + "OutcomeAnalysisCIUpperLimit":"1.48", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG002" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.71", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.91", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.54", + "OutcomeAnalysisCIUpperLimit":"1.52", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm C vs A" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death", + "OutcomeMeasureDescription":"Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"77" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"73" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"73" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"61" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"54" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.98", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.00", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.73", + "OutcomeAnalysisCIUpperLimit":"1.38", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.44", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.30", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.82", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.55", + "OutcomeAnalysisCIUpperLimit":"1.20", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.24", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.80", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.54", + "OutcomeAnalysisCIUpperLimit":"1.17", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm C vs A" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death", + "OutcomeMeasureDescription":"Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"91" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"79" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"64" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"53" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"53" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.52", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.10", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.82", + "OutcomeAnalysisCIUpperLimit":"1.49", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM." + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.34", + "OutcomeAnalysisPValueComment":"Global test with 2df, adjusted for randomization stratification factors", + "OutcomeAnalysisStatisticalMethod":"Log Rank" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.19", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.78", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.54", + "OutcomeAnalysisCIUpperLimit":"1.13", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.25", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.81", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.56", + "OutcomeAnalysisCIUpperLimit":"1.16", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm C vs A" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: Weight-for-age Z-score", + "OutcomeMeasureDescription":"Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"age-adjusted z-score", + "OutcomeMeasureTimeFrame":"Baseline and a median of 4 years (maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"0.76", + "OutcomeMeasurementSpread":"1.05" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"0.78", + "OutcomeMeasurementSpread":"1.01" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"0.72", + "OutcomeMeasurementSpread":"0.95" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"0.79", + "OutcomeMeasurementSpread":"1.00" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"0.80", + "OutcomeMeasurementSpread":"1.13" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.71", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.58", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: Height-for-age Z-score", + "OutcomeMeasureDescription":"Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"age-adjusted z-score", + "OutcomeMeasureTimeFrame":"Baseline and a median of 4 years (maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"0.36", + "OutcomeMeasurementSpread":"0.65" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"0.43", + "OutcomeMeasurementSpread":"0.66" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"0.40", + "OutcomeMeasurementSpread":"0.67" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"0.40", + "OutcomeMeasurementSpread":"0.65" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"0.38", + "OutcomeMeasurementSpread":"0.64" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.07", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.90", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score", + "OutcomeMeasureDescription":"Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"age-adjusted z-score", + "OutcomeMeasureTimeFrame":"Baseline and a median of 4 years (maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"0.65", + "OutcomeMeasurementSpread":"1.28" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"0.61", + "OutcomeMeasurementSpread":"1.20" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"0.56", + "OutcomeMeasurementSpread":"1.11" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"0.64", + "OutcomeMeasurementSpread":"1.21" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"0.69", + "OutcomeMeasurementSpread":"1.39" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.64", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.30", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM: Change From Baseline in CD4% to Week 72", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4% (97% completeness)", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Error", + "OutcomeMeasureUnitOfMeasure":"percentage of total lymphocytes", + "OutcomeMeasureTimeFrame":"Baseline, week 72", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"577" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"563" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"17.2", + "OutcomeMeasurementSpread":"0.36" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"16.7", + "OutcomeMeasurementSpread":"0.35" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.45", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM: Change From Baseline in CD4% to Week 144", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4% (95% completeness)", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Error", + "OutcomeMeasureUnitOfMeasure":"percentage of total lymphocytes", + "OutcomeMeasureTimeFrame":"Baseline, week 144", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"579" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"557" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"19.7", + "OutcomeMeasurementSpread":"0.38" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"19.4", + "OutcomeMeasurementSpread":"0.38" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.70", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72", + "OutcomeMeasureDescription":"Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Error", + "OutcomeMeasureUnitOfMeasure":"absolute cells per mm3", + "OutcomeMeasureTimeFrame":"Baseline, week 72", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"326" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"325" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"208" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"231" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"212" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"408", + "OutcomeMeasurementSpread":"22.2" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"385", + "OutcomeMeasurementSpread":"19.8" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"402", + "OutcomeMeasurementSpread":"24.7" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"447", + "OutcomeMeasurementSpread":"28.5" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"336", + "OutcomeMeasurementSpread":"22.5" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.59", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisCIPctValue":"0" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.01", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144", + "OutcomeMeasureDescription":"Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Error", + "OutcomeMeasureUnitOfMeasure":"absolute cells per mm3", + "OutcomeMeasureTimeFrame":"Baseline, week 144", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"326" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"320" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"201" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"231" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"214" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"418", + "OutcomeMeasurementSpread":"20.8" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"420", + "OutcomeMeasurementSpread":"22.5" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"446", + "OutcomeMeasurementSpread":"25.3" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"450", + "OutcomeMeasurementSpread":"28.9" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"360", + "OutcomeMeasurementSpread":"24.0" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.81", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.03", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline", + "OutcomeMeasureDescription":"Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.", + "OutcomeMeasurePopulationDescription":"Viral loads were assayed retrospectively in a random subset of children", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"72 weeks", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"98" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"102" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"73" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"85" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"42" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"76" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"78" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"56" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"72" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"26" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.86", + "OutcomeAnalysisStatisticalMethod":"Chi-squared" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.02", + "OutcomeAnalysisStatisticalMethod":"Chi-squared" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline", + "OutcomeMeasureDescription":"Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.", + "OutcomeMeasurePopulationDescription":"Viral load was assayed retrospectively at week 144 on a random subset of participants, plus all those aged <5 years at enrolment", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"144 weeks", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"284" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"266" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"168" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"180" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"203" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"192" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"193" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"127" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"135" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"124" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.20", + "OutcomeAnalysisStatisticalMethod":"Chi-squared" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.002", + "OutcomeAnalysisStatisticalMethod":"Chi-squared" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure", + "OutcomeMeasureDescription":"Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"28" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"35" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.22", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.78", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.48", + "OutcomeAnalysisCIUpperLimit":"1.29", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART", + "OutcomeMeasureDescription":"Number of participants with a new grade 3 or 4 adverse event definitely/probably or uncertainly related to ART, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"30" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"42" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"14" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"30" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"28" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.09", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.672", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.420", + "OutcomeAnalysisCIUpperLimit":"1.075", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.04", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.017", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"2.16", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.15", + "OutcomeAnalysisCIUpperLimit":"4.08", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.034", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"2.00", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.05", + "OutcomeAnalysisCIUpperLimit":"3.80", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm C vs A" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV", + "OutcomeMeasureDescription":"Number of participants with a new serious adverse events not solely related to HIV, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"147" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"117" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"87" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"82" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"95" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.04", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.30", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.02", + "OutcomeAnalysisCIUpperLimit":"1.66", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.53", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.60", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.92", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.68", + "OutcomeAnalysisCIUpperLimit":"1.25", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.56", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.09", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.81", + "OutcomeAnalysisCIUpperLimit":"1.46", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm C vs A" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: New ART-modifying Adverse Event", + "OutcomeMeasureDescription":"Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"31" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"32" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"8" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"30" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"25" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.84", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"0.95", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"0.58", + "OutcomeAnalysisCIUpperLimit":"1.56", + "OutcomeAnalysisEstimateComment":"Hazard ratio is CDM vs LCM" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.002", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Global test with 2df, adjusted for randomization stratification factors" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.001", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"3.80", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.74", + "OutcomeAnalysisCIUpperLimit":"8.29", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm B vs A" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.006", + "OutcomeAnalysisStatisticalMethod":"Regression, Cox", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"3.09", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.39", + "OutcomeAnalysisCIUpperLimit":"6.85", + "OutcomeAnalysisEstimateComment":"Hazard ratio is Arm C vs A" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)", + "OutcomeMeasureDescription":"Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"% of visits reporting missed pills", + "OutcomeMeasureTimeFrame":"Median 4 years (from randomization to 16 March 2012; maximum 5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Clinically Driven Monitoring (CDM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "OutcomeGroupDescription":"Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits." + },{ + "OutcomeGroupId":"OG002", + "OutcomeGroupTitle":"Arm A: ABC+3TC+NNRTI", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG003", + "OutcomeGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + },{ + "OutcomeGroupId":"OG004", + "OutcomeGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "OutcomeGroupDescription":"Other Names:\n\nZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age." + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"606" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"600" + },{ + "OutcomeDenomCountGroupId":"OG002", + "OutcomeDenomCountValue":"397" + },{ + "OutcomeDenomCountGroupId":"OG003", + "OutcomeDenomCountValue":"404" + },{ + "OutcomeDenomCountGroupId":"OG004", + "OutcomeDenomCountValue":"405" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"8.5", + "OutcomeMeasurementSpread":"11.1" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"9.4", + "OutcomeMeasurementSpread":"12.4" + },{ + "OutcomeMeasurementGroupId":"OG002", + "OutcomeMeasurementValue":"8.3", + "OutcomeMeasurementSpread":"10.8" + },{ + "OutcomeMeasurementGroupId":"OG003", + "OutcomeMeasurementValue":"9.5", + "OutcomeMeasurementSpread":"11.8" + },{ + "OutcomeMeasurementGroupId":"OG004", + "OutcomeMeasurementValue":"9.1", + "OutcomeMeasurementSpread":"12.7" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.53", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + },{ + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG002", + "OG003", + "OG004" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.46", + "OutcomeAnalysisStatisticalMethod":"Generalized estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation", + "OutcomeMeasureDescription":"Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.", + "OutcomeMeasurePopulationDescription":"All participants with viral load assayed in stored specimens (98% of those randomized)", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"96 weeks", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"331" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"326" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"230" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"234" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.52", + "OutcomeAnalysisStatisticalMethod":"Chi-squared", + "OutcomeAnalysisParamType":"Risk Difference (RD)", + "OutcomeAnalysisParamValue":"-2.3", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-9.3", + "OutcomeAnalysisCIUpperLimit":"4.7" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4%", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"percentage of total lymphocytes", + "OutcomeMeasureTimeFrame":"Randomisation to once vs twice daily, week 48", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"336" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"331" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"0.9", + "OutcomeMeasurementSpread":"6.1" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"1.3", + "OutcomeMeasurementSpread":"5.4" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.39", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"-0.4", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-1.2", + "OutcomeAnalysisCIUpperLimit":"0.5", + "OutcomeAnalysisEstimateComment":"Difference is once-daily minus twice-daily" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4%", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"percentage of total lymphocytes", + "OutcomeMeasureTimeFrame":"Baseline, week 72", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"332" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"325" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1.9", + "OutcomeMeasurementSpread":"6.3" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"1.9", + "OutcomeMeasurementSpread":"5.3" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.98", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"-0.0", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-0.9", + "OutcomeAnalysisCIUpperLimit":"0.9", + "OutcomeAnalysisEstimateComment":"Difference is once-daily minus twice-daily" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4%", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"percentage of lymphocytes", + "OutcomeMeasureTimeFrame":"Randomisation to once vs twice daily, week 96", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"306" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"304" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1.6", + "OutcomeMeasurementSpread":"7.0" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"2.5", + "OutcomeMeasurementSpread":"6.3" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.12", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"-0.8", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-1.9", + "OutcomeAnalysisCIUpperLimit":"0.2", + "OutcomeAnalysisEstimateComment":"Difference is once-daily minus twice-daily" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48", + "OutcomeMeasureDescription":"Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "OutcomeMeasurePopulationDescription":"All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"cells per mm3", + "OutcomeMeasureTimeFrame":"Randomisation to once vs twice daily, week 48", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"193" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"170" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"3", + "OutcomeMeasurementSpread":"348" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"-3", + "OutcomeMeasurementSpread":"301" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.82", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"8", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-60", + "OutcomeAnalysisCIUpperLimit":"76", + "OutcomeAnalysisEstimateComment":"Difference is once-daily minus twice-daily" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72", + "OutcomeMeasureDescription":"All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured", + "OutcomeMeasurePopulationDescription":"All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"cells per mm3", + "OutcomeMeasureTimeFrame":"Baseline, week 72", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"190" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"165" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"-6", + "OutcomeMeasurementSpread":"350" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"27", + "OutcomeMeasurementSpread":"316" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.36", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"-33", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-104", + "OutcomeAnalysisCIUpperLimit":"38", + "OutcomeAnalysisEstimateComment":"Difference is once-daily minus twice-daily" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96", + "OutcomeMeasureDescription":"All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured", + "OutcomeMeasurePopulationDescription":"All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"cells per mm3", + "OutcomeMeasureTimeFrame":"Randomisation to once vs twice daily, week 96", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"171" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"149" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"-26", + "OutcomeMeasurementSpread":"445" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"60", + "OutcomeMeasurementSpread":"737" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.20", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"-87", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-220", + "OutcomeAnalysisCIUpperLimit":"46", + "OutcomeAnalysisEstimateComment":"Difference is once-daily minus twice-daily" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality", + "OutcomeMeasureDescription":"Number of participants who died, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Once-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Twice-daily ABC+3TC", + "OutcomeGroupDescription":"Other Names:\n\nABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"336" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"333" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"4" + } + ] + } + } + ] + } + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death", + "OutcomeMeasureDescription":"Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)", + 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Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"age-adjusted z-score", + "OutcomeMeasureTimeFrame":"Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "OutcomeGroupDescription":"Other Names:\n\ntrimethoprim+sulfamethoxazole" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Stopped Cotrimoxazole Prophylaxis" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"376" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"382" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"-0.24", + "OutcomeMeasurementSpread":"0.54" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"-0.28", + "OutcomeMeasurementSpread":"0.45" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.34", + "OutcomeAnalysisStatisticalMethod":"Generalised estimating equations", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Cotrimoxazole: Change From Baseline in CD4% to Week 72", + "OutcomeMeasurePopulationDescription":"All participants alive in follow-up with CD4%", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"percentage of total lymphocytes", + "OutcomeMeasureTimeFrame":"Baseline, week 72", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "OutcomeGroupDescription":"Other Names:\n\ntrimethoprim+sulfamethoxazole" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Stopped Cotrimoxazole Prophylaxis" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"360" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"360" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"1.7", + "OutcomeMeasurementSpread":"5.5" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"1.1", + "OutcomeMeasurementSpread":"5.7" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.13", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"-0.6", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-1.4", + "OutcomeAnalysisCIUpperLimit":"0.2", + "OutcomeAnalysisEstimateComment":"Difference is stop minus continue" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72", + "OutcomeMeasureDescription":"Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)", + "OutcomeMeasurePopulationDescription":"All participants aged >5 years at randomization to stop versus continue alive in follow-up with CD4 measured", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"cells per mm3", + "OutcomeMeasureTimeFrame":"Baseline, week 72", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "OutcomeGroupDescription":"Other Names:\n\ntrimethoprim+sulfamethoxazole" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Stopped Cotrimoxazole Prophylaxis" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"253" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"254" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"7", + "OutcomeMeasurementSpread":"310" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"-2", + "OutcomeMeasurementSpread":"303" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.68", + "OutcomeAnalysisStatisticalMethod":"Regression, Linear", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Mean Difference (Net)", + "OutcomeAnalysisParamValue":"-11", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"-65", + "OutcomeAnalysisCIUpperLimit":"42", + "OutcomeAnalysisEstimateComment":"Difference is stop minus continue" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV", + "OutcomeMeasureDescription":"Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Number", + "OutcomeMeasureUnitOfMeasure":"participants", + "OutcomeMeasureTimeFrame":"Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "OutcomeGroupDescription":"Other Names:\n\ntrimethoprim+sulfamethoxazole" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Stopped Cotrimoxazole Prophylaxis" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"376" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"382" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"32" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"48" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.04", + "OutcomeAnalysisStatisticalMethod":"Log Rank", + "OutcomeAnalysisStatisticalComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisParamType":"Hazard Ratio (HR)", + "OutcomeAnalysisParamValue":"1.60", + "OutcomeAnalysisCIPctValue":"95", + "OutcomeAnalysisCINumSides":"2-Sided", + "OutcomeAnalysisCILowerLimit":"1.02", + "OutcomeAnalysisCIUpperLimit":"2.50", + "OutcomeAnalysisEstimateComment":"Hazard ratio is stop vs continue" + } + ] + } + },{ + "OutcomeMeasureType":"Secondary", + "OutcomeMeasureTitle":"Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)", + "OutcomeMeasureDescription":"Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.", + "OutcomeMeasureReportingStatus":"Posted", + "OutcomeMeasureParamType":"Mean", + "OutcomeMeasureDispersionType":"Standard Deviation", + "OutcomeMeasureUnitOfMeasure":"% of visits reporting missed pills", + "OutcomeMeasureTimeFrame":"Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)", + "OutcomeGroupList":{ + "OutcomeGroup":[ + { + "OutcomeGroupId":"OG000", + "OutcomeGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "OutcomeGroupDescription":"Other Names:\n\ntrimethoprim+sulfamethoxazole" + },{ + "OutcomeGroupId":"OG001", + "OutcomeGroupTitle":"Stopped Cotrimoxazole Prophylaxis" + } + ] + }, + "OutcomeDenomList":{ + "OutcomeDenom":[ + { + "OutcomeDenomUnits":"Participants", + "OutcomeDenomCountList":{ + "OutcomeDenomCount":[ + { + "OutcomeDenomCountGroupId":"OG000", + "OutcomeDenomCountValue":"376" + },{ + "OutcomeDenomCountGroupId":"OG001", + "OutcomeDenomCountValue":"382" + } + ] + } + } + ] + }, + "OutcomeClassList":{ + "OutcomeClass":[ + { + "OutcomeCategoryList":{ + "OutcomeCategory":[ + { + "OutcomeMeasurementList":{ + "OutcomeMeasurement":[ + { + "OutcomeMeasurementGroupId":"OG000", + "OutcomeMeasurementValue":"9", + "OutcomeMeasurementSpread":"13" + },{ + "OutcomeMeasurementGroupId":"OG001", + "OutcomeMeasurementValue":"8", + "OutcomeMeasurementSpread":"13" + } + ] + } + } + ] + } + } + ] + }, + "OutcomeAnalysisList":{ + "OutcomeAnalysis":[ + { + "OutcomeAnalysisGroupIdList":{ + "OutcomeAnalysisGroupId":[ + "OG000", + "OG001" + ] + }, + "OutcomeAnalysisTestedNonInferiority":"No", + "OutcomeAnalysisNonInferiorityType":"Superiority or Other", + "OutcomeAnalysisPValue":"0.21", + "OutcomeAnalysisPValueComment":"Adjusted for randomization stratification factors", + "OutcomeAnalysisStatisticalMethod":"Generalised estimating equation", + "OutcomeAnalysisStatisticalComment":"Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks" + } + ] + } + } + ] + } + }, + "AdverseEventsModule":{ + "EventsFrequencyThreshold":"5", + "EventsTimeFrame":"LCM vs CDM and induction-maintenance: median 4 years (maximum 5 years); for randomizations; once vs twice daily: median 2 years (maximum 2.6 years); cotrimoxazole: median 2 years (maximum 2.5 years)", + "EventsDescription":"Children were reviewed by a doctor at every scheduled doctor visit, as well as additional visits, and prompts on the doctor follow-up CRF asked about new/worsening/resolved Serious Adverse Events and Grade 3 or 4 Adverse Events.", + "EventGroupList":{ + "EventGroup":[ + { + "EventGroupId":"EG000", + "EventGroupTitle":"Clinically Driven Monitoring (CDM)", + "EventGroupDescription":"Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.", + "EventGroupSeriousNumAffected":"147", + "EventGroupSeriousNumAtRisk":"606", + "EventGroupOtherNumAffected":"190", + "EventGroupOtherNumAtRisk":"606" + },{ + "EventGroupId":"EG001", + "EventGroupTitle":"Laboratory Plus Clinical Monitoring (LCM)", + "EventGroupDescription":"Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.", + "EventGroupSeriousNumAffected":"117", + "EventGroupSeriousNumAtRisk":"600", + "EventGroupOtherNumAffected":"198", + "EventGroupOtherNumAtRisk":"600" + },{ + "EventGroupId":"EG002", + "EventGroupTitle":"Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI", + "EventGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.", + "EventGroupSeriousNumAffected":"87", + "EventGroupSeriousNumAtRisk":"397", + "EventGroupOtherNumAffected":"96", + "EventGroupOtherNumAtRisk":"397" + },{ + "EventGroupId":"EG003", + "EventGroupTitle":"Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance", + "EventGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.", + "EventGroupSeriousNumAffected":"92", + "EventGroupSeriousNumAtRisk":"404", + "EventGroupOtherNumAffected":"124", + "EventGroupOtherNumAtRisk":"404" + },{ + "EventGroupId":"EG004", + "EventGroupTitle":"Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance", + "EventGroupDescription":"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.\n\nArm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.", + "EventGroupSeriousNumAffected":"95", + "EventGroupSeriousNumAtRisk":"405", + "EventGroupOtherNumAffected":"168", + "EventGroupOtherNumAtRisk":"405" + },{ + "EventGroupId":"EG005", + "EventGroupTitle":"Once-daily ABC+3TC", + "EventGroupDescription":"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO\n\nOnce-daily ABC+3TC", + "EventGroupSeriousNumAffected":"30", + "EventGroupSeriousNumAtRisk":"336", + "EventGroupOtherNumAffected":"33", + "EventGroupOtherNumAtRisk":"336" + },{ + "EventGroupId":"EG006", + "EventGroupTitle":"Twice-daily ABC+3TC", + "EventGroupDescription":"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO\n\nTwice-daily ABC+3TC", + "EventGroupSeriousNumAffected":"37", + "EventGroupSeriousNumAtRisk":"333", + "EventGroupOtherNumAffected":"26", + "EventGroupOtherNumAtRisk":"333" + },{ + "EventGroupId":"EG007", + "EventGroupTitle":"Continued Cotrimoxazole Prophylaxis", + "EventGroupDescription":"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole\n\nContinued cotrimoxazole prophylaxis", + "EventGroupSeriousNumAffected":"32", + "EventGroupSeriousNumAtRisk":"376", + "EventGroupOtherNumAffected":"37", + "EventGroupOtherNumAtRisk":"376" + },{ + "EventGroupId":"EG008", + "EventGroupTitle":"Stopped Cotrimoxazole Prophylaxis", + "EventGroupDescription":"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.\n\nStopped cotrimoxazole prophylaxis", + "EventGroupSeriousNumAffected":"48", + "EventGroupSeriousNumAtRisk":"382", + "EventGroupOtherNumAffected":"26", + "EventGroupOtherNumAtRisk":"382" + } + ] + }, + "SeriousEventList":{ + "SeriousEvent":[ + { + "SeriousEventTerm":"Coma", + "SeriousEventOrganSystem":"Nervous system disorders", + "SeriousEventSourceVocabulary":"Trial-specific", + "SeriousEventAssessmentType":"Systematic Assessment", + "SeriousEventStatsList":{ + "SeriousEventStats":[ + { + "SeriousEventStatsGroupId":"EG000", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"606" + },{ + "SeriousEventStatsGroupId":"EG001", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"600" + },{ + "SeriousEventStatsGroupId":"EG002", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"397" + },{ + "SeriousEventStatsGroupId":"EG003", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"404" + },{ + "SeriousEventStatsGroupId":"EG004", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"405" + },{ + "SeriousEventStatsGroupId":"EG005", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"336" + },{ + "SeriousEventStatsGroupId":"EG006", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"333" + },{ + "SeriousEventStatsGroupId":"EG007", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"376" + },{ + "SeriousEventStatsGroupId":"EG008", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"382" + } + ] + } + },{ + "SeriousEventTerm":"Acute diarrhoea", + "SeriousEventOrganSystem":"Gastrointestinal disorders", + "SeriousEventSourceVocabulary":"Trial-specific", + "SeriousEventAssessmentType":"Systematic Assessment", + "SeriousEventStatsList":{ + "SeriousEventStats":[ + { + "SeriousEventStatsGroupId":"EG000", + "SeriousEventStatsNumEvents":"10", + "SeriousEventStatsNumAffected":"10", + "SeriousEventStatsNumAtRisk":"606" + },{ + "SeriousEventStatsGroupId":"EG001", + "SeriousEventStatsNumEvents":"6", + "SeriousEventStatsNumAffected":"6", + "SeriousEventStatsNumAtRisk":"600" + },{ + "SeriousEventStatsGroupId":"EG002", + "SeriousEventStatsNumEvents":"4", + "SeriousEventStatsNumAffected":"4", + "SeriousEventStatsNumAtRisk":"397" + },{ + "SeriousEventStatsGroupId":"EG003", + "SeriousEventStatsNumEvents":"7", + "SeriousEventStatsNumAffected":"7", + "SeriousEventStatsNumAtRisk":"404" + },{ + "SeriousEventStatsGroupId":"EG004", + "SeriousEventStatsNumEvents":"5", + "SeriousEventStatsNumAffected":"5", + "SeriousEventStatsNumAtRisk":"405" + },{ + "SeriousEventStatsGroupId":"EG005", + "SeriousEventStatsNumEvents":"2", + "SeriousEventStatsNumAffected":"2", + "SeriousEventStatsNumAtRisk":"336" + },{ + "SeriousEventStatsGroupId":"EG006", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"333" + },{ + "SeriousEventStatsGroupId":"EG007", + "SeriousEventStatsNumEvents":"3", + "SeriousEventStatsNumAffected":"3", + "SeriousEventStatsNumAtRisk":"376" + },{ + "SeriousEventStatsGroupId":"EG008", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"382" + } + ] + } + },{ + "SeriousEventTerm":"Hyperthyroidism", + "SeriousEventOrganSystem":"Endocrine disorders", + "SeriousEventSourceVocabulary":"Trial-specific", + "SeriousEventAssessmentType":"Systematic Assessment", + "SeriousEventStatsList":{ + "SeriousEventStats":[ + { + "SeriousEventStatsGroupId":"EG000", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"606" + },{ + "SeriousEventStatsGroupId":"EG001", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"600" + },{ + "SeriousEventStatsGroupId":"EG002", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"397" + },{ + "SeriousEventStatsGroupId":"EG003", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"404" + },{ + "SeriousEventStatsGroupId":"EG004", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"405" + },{ + "SeriousEventStatsGroupId":"EG005", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"336" + },{ + "SeriousEventStatsGroupId":"EG006", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"333" + },{ + "SeriousEventStatsGroupId":"EG007", + "SeriousEventStatsNumEvents":"0", + "SeriousEventStatsNumAffected":"0", + "SeriousEventStatsNumAtRisk":"376" + },{ + "SeriousEventStatsGroupId":"EG008", + "SeriousEventStatsNumEvents":"1", + "SeriousEventStatsNumAffected":"1", + "SeriousEventStatsNumAtRisk":"382" + } + ] + } + },{ + "SeriousEventTerm":"Gasteroenteritis", + "SeriousEventOrganSystem":"Gastrointestinal disorders", + "SeriousEventSourceVocabulary":"Trial-specific", + "SeriousEventAssessmentType":"Systematic Assessment", + "SeriousEventStatsList":{ + "SeriousEventStats":[ + { + "SeriousEventStatsGroupId":"EG000", + "SeriousEventStatsNumEvents":"3", + "SeriousEventStatsNumAffected":"3", + "SeriousEventStatsNumAtRisk":"606" + },{ + "SeriousEventStatsGroupId":"EG001", + "SeriousEventStatsNumEvents":"2", + "SeriousEventStatsNumAffected":"2", + 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"InterventionBrowseLeafName":"Aspartic Acid", + "InterventionBrowseLeafRelevance":"low" + },{ + "InterventionBrowseLeafId":"T447", + "InterventionBrowseLeafName":"Folinic Acid", + "InterventionBrowseLeafRelevance":"low" + },{ + "InterventionBrowseLeafId":"T446", + "InterventionBrowseLeafName":"Folic Acid", + "InterventionBrowseLeafRelevance":"low" + },{ + "InterventionBrowseLeafId":"T448", + "InterventionBrowseLeafName":"Folate", + "InterventionBrowseLeafRelevance":"low" + },{ + "InterventionBrowseLeafId":"T475", + "InterventionBrowseLeafName":"Vitamin B9", + "InterventionBrowseLeafRelevance":"low" + } + ] + }, + "InterventionBrowseBranchList":{ + "InterventionBrowseBranch":[ + { + "InterventionBrowseBranchAbbrev":"Infl", + "InterventionBrowseBranchName":"Anti-Inflammatory Agents" + },{ + "InterventionBrowseBranchAbbrev":"ARhu", + "InterventionBrowseBranchName":"Antirheumatic Agents" + },{ + "InterventionBrowseBranchAbbrev":"Analg", + "InterventionBrowseBranchName":"Analgesics" + },{ + "InterventionBrowseBranchAbbrev":"All", + "InterventionBrowseBranchName":"All Drugs and Chemicals" + },{ + "InterventionBrowseBranchAbbrev":"Infe", + "InterventionBrowseBranchName":"Anti-Infective Agents" + },{ + "InterventionBrowseBranchAbbrev":"AnDyAg", + "InterventionBrowseBranchName":"Anti-Dyskinesia Agents" + },{ + "InterventionBrowseBranchAbbrev":"Micro", + "InterventionBrowseBranchName":"Micronutrients" + },{ + "InterventionBrowseBranchAbbrev":"Hemat", + "InterventionBrowseBranchName":"Hematinics" + },{ + "InterventionBrowseBranchAbbrev":"AA", + "InterventionBrowseBranchName":"Amino Acids" + },{ + "InterventionBrowseBranchAbbrev":"Vi", + "InterventionBrowseBranchName":"Vitamins" + } + ] + } + } + } + } + } + ] + } + } \ No newline at end of file diff --git a/spec/support/json_data/ctg_api_all.json b/spec/support/json_data/ctg_api_all.json index ff0751a50..f1872c3f5 100644 --- a/spec/support/json_data/ctg_api_all.json +++ b/spec/support/json_data/ctg_api_all.json @@ -3,8 +3,8 @@ "APIVrs":"1.01.03", "DataVrs":"2021:08:02 22:24:55.147", "Expression":"ALL", - "NStudiesAvail":3, - "NStudiesFound":3, + "NStudiesAvail":2, + "NStudiesFound":2, "MinRank":1, "MaxRank":1000, "NStudiesReturned":1000, @@ -36,17 +36,6 @@ "LastUpdatePostDate":[ "August 3, 2021" ] - },{ - "Rank":3, - "NCTId":[ - "invalid-nct-id" - ], - "StudyFirstPostDate":[ - "August 3, 2021" - ], - "LastUpdatePostDate":[ - "August 3, 2021" - ] } ] } From ab2ee7fbcaa42790575bcd4f7158864203c5a404 Mon Sep 17 00:00:00 2001 From: Kassidy Holtzman Date: Thu, 19 Oct 2023 14:31:49 -0400 Subject: [PATCH 3/3] All tests are passing --- spec/models/utils/util_updater_spec.rb | 9 ++++++--- 1 file changed, 6 insertions(+), 3 deletions(-) diff --git a/spec/models/utils/util_updater_spec.rb b/spec/models/utils/util_updater_spec.rb index af2c6978a..117212daf 100644 --- a/spec/models/utils/util_updater_spec.rb +++ b/spec/models/utils/util_updater_spec.rb @@ -214,9 +214,12 @@ context 'when something went wrong with the loads' do it 'should log errors, send notification with apprpriate subject line & not refresh the public db' do - updater=Util::Updater.new - expect(updater).to receive(:send_notification).once - expect(updater.db_mgr).to receive(:refresh_public_db).never + updater=Util::Updater.new + db_manager_instance=updater.db_mgr + expect_any_instance_of(Util::DbManager).not_to receive(:refresh_public_db) + allow(Notifier).to receive(:report_load_event) + expect_any_instance_of(Util::DbManager).to receive(:remove_constraints).and_raise('NoMethodError') + updater.execute # updater.run expect(updater.load_event.problems).to include('NoMethodError') expect(updater.load_event.problems.size).to be > 100