Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT01910402
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C562325', 'term': 'dolutegravir'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 48 for Randomized Phase; from Weeks 48 to 432 for Continuation Phase', 'description': 'All-Cause Mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase, which comprised of all randomized participants who received at least one dose of study treatment. Safety-Continuation Population was used for the Continuation Phase which comprised of all participants in the DTG/ABC/3TC group who received at least 1 dose of study treatment after entering the Continuation Phase.', 'eventGroups': [{'id': 'EG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.', 'otherNumAtRisk': 248, 'deathsNumAtRisk': 248, 'otherNumAffected': 138, 'seriousNumAtRisk': 248, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.', 'otherNumAtRisk': 247, 'deathsNumAtRisk': 247, 'otherNumAffected': 164, 'seriousNumAtRisk': 247, 'deathsNumAffected': 0, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 30, 'seriousNumAtRisk': 149, 'deathsNumAffected': 1, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scleroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Acute hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 247, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '3.1', 'ciUpperLimit': '17.8', 'pValueComment': 'If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \\<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\\<vs. \\>100,000 c/mL) and CD4+ cell count (=\\<350 cells per millimeter cube (cells/mm\\^3) or \\>350 cells/mm\\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'HIV-1 RNA <50 c/mL, Baseline (Day 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <50 c/mL, Week 4', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <50 c/mL, Week 12', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <50 c/mL, Week 24', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <50 c/mL, Week 36', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <50 c/mL, Week 48', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <400 c/mL, Baseline (Day 1)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <400 c/mL, Week 4', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <400 c/mL, Week 12', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <400 c/mL, Week 24', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <400 c/mL, Week 36', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 RNA <400 c/mL, Week 48', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Percentage of participants with plasma HIV-1 RNA \\<50 and \\<400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Week 96, n=99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 432, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96 and Week 432', 'description': 'Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \\<50 c/mL were reported. Percentage values are rounded off.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n=245, 238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.591', 'spread': '0.8015', 'groupId': 'OG000'}, {'value': '-1.923', 'spread': '0.5330', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.756', 'spread': '0.8920', 'groupId': 'OG000'}, {'value': '-2.541', 'spread': '0.7373', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n=225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.789', 'spread': '0.9160', 'groupId': 'OG000'}, {'value': '-2.726', 'spread': '0.8890', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n=221, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.838', 'spread': '0.8589', 'groupId': 'OG000'}, {'value': '-2.772', 'spread': '0.8451', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=207, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.874', 'spread': '0.8035', 'groupId': 'OG000'}, {'value': '-2.752', 'spread': '0.8433', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Week 96, n=99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.911', 'spread': '0.7970', 'groupId': 'OG000'}]}]}, {'title': 'Week 432, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.107', 'spread': '0.7659', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 96 and Week 432', 'description': 'Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Baseline (Day 1), n=248, 247', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.481', 'spread': '0.8111', 'groupId': 'OG000'}, {'value': '4.441', 'spread': '0.8023', 'groupId': 'OG001'}]}]}, {'title': 'Week 4, n=245, 238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.895', 'spread': '0.6872', 'groupId': 'OG000'}, {'value': '2.516', 'spread': '0.6193', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.748', 'spread': '0.5458', 'groupId': 'OG000'}, {'value': '1.908', 'spread': '0.4926', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n=225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.724', 'spread': '0.5935', 'groupId': 'OG000'}, {'value': '1.710', 'spread': '0.4484', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n=221, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.666', 'spread': '0.3982', 'groupId': 'OG000'}, {'value': '1.658', 'spread': '0.3362', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=207, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.619', 'spread': '0.1986', 'groupId': 'OG000'}, {'value': '1.657', 'spread': '0.2743', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Week 96, n=99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.591', 'spread': '0.0080', 'groupId': 'OG000'}]}]}, {'title': 'Week 432, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.590', 'spread': '0.0000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 96 and Week 432', 'description': 'Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n=245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.9', 'spread': '140.02', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '108.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=236, 224', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '143.8', 'spread': '142.19', 'groupId': 'OG000'}, {'value': '124.4', 'spread': '133.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n=226, 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200.6', 'spread': '162.37', 'groupId': 'OG000'}, {'value': '163.0', 'spread': '126.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n=219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '230.7', 'spread': '163.61', 'groupId': 'OG000'}, {'value': '191.4', 'spread': '167.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=208, 191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '248.8', 'spread': '172.01', 'groupId': 'OG000'}, {'value': '230.7', 'spread': '189.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Week 96, n=99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '286.5', 'spread': '196.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 432, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '254.7', 'spread': '342.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 96, Week 432', 'description': 'Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Baseline (Day 1), n=248, 247', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '369.7', 'spread': '225.67', 'groupId': 'OG000'}, {'value': '380.3', 'spread': '223.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 4, n=245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '465.0', 'spread': '252.51', 'groupId': 'OG000'}, {'value': '455.1', 'spread': '244.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=236, 224', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '509.5', 'spread': '276.79', 'groupId': 'OG000'}, {'value': '506.2', 'spread': '266.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n=226, 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '563.8', 'spread': '303.10', 'groupId': 'OG000'}, {'value': '542.5', 'spread': '265.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n=219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '592.8', 'spread': '291.62', 'groupId': 'OG000'}, {'value': '569.2', 'spread': '299.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=208, 191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '608.8', 'spread': '298.95', 'groupId': 'OG000'}, {'value': '608.5', 'spread': '302.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Week 96, n=99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '635.3', 'spread': '285.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 432, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '553.0', 'spread': '341.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 96 and Week 432', 'description': 'Absolute values in CD4+ cell count were assessed at indicated time points.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Carbon Dioxide, Week 4, n= 244, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Carbon Dioxide, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'Carbon Dioxide, Week 24, n= 224, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Carbon Dioxide, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Carbon Dioxide, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '0', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '0', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'CHLS, Week 4, n= 1, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.446', 'groupId': 'OG001'}]}]}, {'title': 'CHLS, Week 12, n= 224, 221', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.298', 'spread': '0.7492', 'groupId': 'OG000'}, {'value': '-0.058', 'spread': '0.7137', 'groupId': 'OG001'}]}]}, {'title': 'CHLS, Week 24, n= 218, 201', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.317', 'spread': '0.7254', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.7456', 'groupId': 'OG001'}]}]}, {'title': 'CHLS, Week 36, n= 205, 191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.7328', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.7509', 'groupId': 'OG001'}]}]}, {'title': 'CHLS, Week 48, n= 195, 175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.447', 'spread': '0.7441', 'groupId': 'OG000'}, {'value': '0.109', 'spread': '0.7647', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Week 12, n= 226, 224', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.359', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '1.234', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Week 24, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.811', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '1.248', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Week 36, n= 211, 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.753', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Week 48, n= 197, 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.377', 'groupId': 'OG001'}]}]}, {'title': 'HDL CHLS, Direct, Week 4, n= 1, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.0529', 'groupId': 'OG001'}]}]}, {'title': 'HDL CHLS, Direct, Week 12, n= 224, 221', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.182', 'spread': '0.3407', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.2316', 'groupId': 'OG001'}]}]}, {'title': 'HDL CHLS, Direct, Week 24, n= 218, 201', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.201', 'spread': '0.2962', 'groupId': 'OG000'}, {'value': '0.053', 'spread': '0.2819', 'groupId': 'OG001'}]}]}, {'title': 'HDL CHLS, Direct, Week 36, n= 205, 191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.204', 'spread': '0.2943', 'groupId': 'OG000'}, {'value': '0.036', 'spread': '0.2848', 'groupId': 'OG001'}]}]}, {'title': 'HDL CHLS, Direct, Week 48, n= 195, 175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.231', 'spread': '0.2911', 'groupId': 'OG000'}, {'value': '0.081', 'spread': '0.2964', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycaemia, Week 12, n= 226, 224', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.359', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '1.234', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycaemia, Week 24, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.811', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '1.248', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycaemia, Week 36, n= 211, 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.753', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycaemia, Week 48, n= 197, 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.377', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Week 4, n= 244, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.344', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.367', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.355', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Week 24, n= 224, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.339', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.332', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.387', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.346', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Week 12, n= 226, 224', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.359', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '1.234', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Week 24, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.811', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '1.248', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Week 36, n= 211, 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.753', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Week 48, n= 197, 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.377', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Week 4, n= 244, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.344', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.367', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.355', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Week 24, n= 224, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.339', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.332', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.387', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.346', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'LDL CHLS Calculation, Week 4, n= 1, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG000'}, {'value': '-0.123', 'spread': '0.5255', 'groupId': 'OG001'}]}]}, {'title': 'LDL CHLS Calculation, Week 12, n= 221, 219', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.125', 'spread': '0.6045', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.6114', 'groupId': 'OG001'}]}]}, {'title': 'LDL CHLS Calculation, Week 24, n= 213, 201', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.111', 'spread': '0.6209', 'groupId': 'OG000'}, {'value': '-0.111', 'spread': '0.6188', 'groupId': 'OG001'}]}]}, {'title': 'LDL CHLS Calculation, Week 36, n= 201, 188', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.112', 'spread': '0.6385', 'groupId': 'OG000'}, {'value': '-0.099', 'spread': '0.6049', 'groupId': 'OG001'}]}]}, {'title': 'LDL CHLS Calculation, Week 48, n= 190, 175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.213', 'spread': '0.6499', 'groupId': 'OG000'}, {'value': '-0.021', 'spread': '0.6227', 'groupId': 'OG001'}]}]}, {'title': 'LDL CHLS, Direct, Week 12, n= 0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG001'}]}]}, {'title': 'LDL CHLS, Direct, Week 24, n= 1, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.64', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG000'}]}]}, {'title': 'LDL CHLS, Direct, Week 36, n= 1, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG000'}]}]}, {'title': 'LDL CHLS, Direct, Week 48, n= 0, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.1461', 'groupId': 'OG000'}, {'value': '-0.032', 'spread': '0.1726', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.1694', 'groupId': 'OG000'}, {'value': '0.026', 'spread': '0.1634', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.1628', 'groupId': 'OG000'}, {'value': '0.026', 'spread': '0.1701', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.1736', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.1675', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.1736', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.1673', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Week 4, n= 244, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.344', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.367', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.355', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Week 24, n= 224, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.339', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.332', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.387', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.346', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.372', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Week 4, n= 1, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG000'}, {'value': '0.237', 'spread': '0.2491', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Week 12, n= 224, 221', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.6861', 'groupId': 'OG000'}, {'value': '0.167', 'spread': '0.7074', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Week 24, n= 218, 201', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.7108', 'groupId': 'OG000'}, {'value': '0.125', 'spread': '0.6132', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Week 36, n= 205, 191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.6732', 'groupId': 'OG000'}, {'value': '0.157', 'spread': '0.6785', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Week 48, n= 195, 175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.8158', 'groupId': 'OG000'}, {'value': '0.107', 'spread': '0.5527', 'groupId': 'OG001'}]}]}, {'title': 'Urea, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '1.085', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.313', 'groupId': 'OG001'}]}]}, {'title': 'Urea, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '1.097', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '1.409', 'groupId': 'OG001'}]}]}, {'title': 'Urea, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '1.187', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '1.283', 'groupId': 'OG001'}]}]}, {'title': 'Urea, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '1.236', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.256', 'groupId': 'OG001'}]}]}, {'title': 'Urea, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.162', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '1.179', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol \\[CHLS\\], high density lipoprotein \\[HDL\\] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Bilirubin, Week 4, n= 244, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '23.15', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '16.49', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '25', 'spread': '18.38', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '16.31', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '17', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '7.057', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '7.109', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '8.288', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '8.357', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.16', 'spread': '9.983', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '8.063', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.08', 'spread': '10.473', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '9.013', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.29', 'spread': '8.614', 'groupId': 'OG000'}, {'value': '5.86', 'spread': '10.252', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Albumin at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '3.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Alanine aminotransferase, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '27.54', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '15.86', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '27.51', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '20.26', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '27.92', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '20.7', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '36.11', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '20.08', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '28.54', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '31.53', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '14.56', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '28.69', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '30.82', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '17.86', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '41.59', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '19.19', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '30.7', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '28.05', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '25.35', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Week 4, n= 244, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '18.83', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.2', 'spread': '21.11', 'groupId': 'OG000'}, {'value': '-4', 'spread': '13.79', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Week 24, n= 224, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '22.44', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '31.42', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '16.63', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '22.19', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '25.28', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase, Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '68.72', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '549.1', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase, Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '73.7', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '90.39', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase, Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '88.66', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '77.12', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase, Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '155.68', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '132.74', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase, Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '242.66', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '98.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Creatinine Clearance at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'spread': '15.03', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '12.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.3', 'spread': '17.01', 'groupId': 'OG000'}, {'value': '-7', 'spread': '23.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.2', 'spread': '20.36', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '16.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.8', 'spread': '22.35', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '17.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.9', 'spread': '19.62', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '18.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Milliliter per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipase at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n= 245, 237', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '15.06', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '15.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '22.74', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n= 225, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6', 'spread': '21.05', 'groupId': 'OG000'}, {'value': '-6', 'spread': '18.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n= 219, 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '25.62', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '21.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 208, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '29.63', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '20.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n= 1, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1264', 'spread': 'NA', 'comment': 'NA indicates standard deviation could not be calculated for a single participant', 'groupId': 'OG000'}, {'value': '0.2159', 'spread': '0.60727', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 233, 223', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2736', 'spread': '1.0283', 'groupId': 'OG000'}, {'value': '-0.1092', 'spread': '0.73776', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n= 224, 209', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3098', 'spread': '1.11093', 'groupId': 'OG000'}, {'value': '-0.1922', 'spread': '0.79848', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n= 212, 198', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3286', 'spread': '1.01181', 'groupId': 'OG000'}, {'value': '-0.1433', 'spread': '0.79498', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 207, 186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2886', 'spread': '1.01415', 'groupId': 'OG000'}, {'value': '-0.1444', 'spread': '1.23362', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Basophils, Week 4, n= 241, 234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0182', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0198', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Week 12, n= 228, 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0174', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0162', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Week 24, n= 221, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0187', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0155', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Week 36, n= 214, 203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0182', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0158', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, Week 48, n= 206, 189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0199', 'groupId': 'OG000'}, {'value': '0.006', 'spread': '0.0146', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Week 4, n= 241, 234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': '0.1486', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.1648', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Week 12, n= 228, 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.1982', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.1610', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Week 24, n= 221, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.1927', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.1973', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Week 36, n= 214, 203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.2244', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.2139', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, Week 48, n= 206, 189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.1744', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.2274', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Week 4, n= 241, 234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.208', 'spread': '0.4914', 'groupId': 'OG000'}, {'value': '0.119', 'spread': '0.5493', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Week 12, n= 228, 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.257', 'spread': '0.5500', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '0.6690', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Week 24, n= 221, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.317', 'spread': '0.4889', 'groupId': 'OG000'}, {'value': '0.192', 'spread': '0.5910', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Week 36, n= 214, 203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.362', 'spread': '0.5199', 'groupId': 'OG000'}, {'value': '0.178', 'spread': '0.6441', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, Week 48, n= 206, 189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.359', 'spread': '0.5235', 'groupId': 'OG000'}, {'value': '0.261', 'spread': '0.7098', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Week 4, n= 241, 234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.1558', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '0.1391', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Week 12, n= 228, 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.1412', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.1369', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Week 24, n= 221, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.1498', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '0.1581', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Week 36, n= 214, 203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.1448', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.1500', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Week 48, n= 206, 189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.1379', 'groupId': 'OG000'}, {'value': '-0.024', 'spread': '0.1638', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocytes at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n= 243, 234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.244', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.239', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 233, 220', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.351', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.308', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n= 225, 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.373', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.329', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n= 218, 203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.384', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.358', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 207, 190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.365', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.318', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit Count at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n= 243, 234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0003', 'spread': '0.02176', 'groupId': 'OG000'}, {'value': '-0.0042', 'spread': '0.02238', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 233, 220', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0081', 'spread': '0.03157', 'groupId': 'OG000'}, {'value': '0.0000', 'spread': '0.02646', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n= 225, 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0157', 'spread': '0.03209', 'groupId': 'OG000'}, {'value': '0.0051', 'spread': '0.03083', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n= 218, 203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0167', 'spread': '0.03451', 'groupId': 'OG000'}, {'value': '0.0062', 'spread': '0.03379', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 207, 190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0212', 'spread': '0.03293', 'groupId': 'OG000'}, {'value': '0.0107', 'spread': '0.03200', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Proportion of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n= 243, 234', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n= 233, 220', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n= 225, 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '4.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 36, n= 218, 203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 207, 190', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '5.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Femtoliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.045', 'spread': '0.0477', 'groupId': 'OG000'}, {'value': '0.070', 'spread': '0.0477', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.159', 'ciUpperLimit': '0.107', 'statisticalMethod': 'Multiple Imputed Dataset - MAR', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Participants on lipid lowering therapy at Baseline were excluded from analysis. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TC/HDL Ratio at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.264', 'spread': '0.0707', 'groupId': 'OG000'}, {'value': '-0.158', 'spread': '0.0784', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3165', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.106', 'ciLowerLimit': '-0.313', 'ciUpperLimit': '0.101', 'statisticalMethod': 'Multiple Imputed Dataset - MAR', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Participants on lipid lowering therapy at Baseline were excluded from analysis. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 24, n= 179, 186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '16.557', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '9.091', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n= 170, 164', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.68', 'spread': '20.597', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '9.393', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 24 and Week 48', 'description': 'Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'milligrams per millimole', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs by Maximum Toxicity-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs by Maximum Toxicity-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Weeks 48 to 432', 'description': 'Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety - Continuation Phase Population comprised of all participants in the DTG/ABC/3TC group who received at least 1 dose of study treatment after entering the Continuation Phase'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any AEs, and SAEs in Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Weeks 48 to 432', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-Continuation Phase Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Hyperglycaemia, Grade 1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycaemia, Grade 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycaemia, Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycaemia, Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Grade 1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Grade 1', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Grade 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase, Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Grade 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Grade 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase, Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Carbon dioxide, Grade 1', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Carbon dioxide, Grade 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Carbon dioxide, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Carbon dioxide, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol, Grade 1', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol, Grade 2', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol, Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase, Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase, Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol calculation, Grade 1', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol calculation, Grade 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol calculation, Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol calculation, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol direct, Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol direct, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol direct, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol direct, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lipase, Grade 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Lipase, Grade 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lipase, Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lipase, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Grade 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Grade 1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Grade 1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Grade 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Grade 1', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Grade 2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Hyperglycaemia, Grade 1, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycaemia, Grade 2, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycaemia, Grade 3, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycaemia, Grade 4, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypernatremia, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hypernatremia, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypernatremia, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypernatremia, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypoglycaemia, Grade 1, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypoglycaemia, Grade 2, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypoglycaemia, Grade 3, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypoglycaemia, Grade 4, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypokalemia, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Hypokalemia, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypokalemia, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hypokalemia, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hyponatremia, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Hyponatremia, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hyponatremia, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hyponatremia, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Grade 1, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Grade 2, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Grade 3, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Grade 4, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol calculation, Grade 1, n=70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol calculation, Grade 2, n=70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol calculation, Grade 3, n=70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol calculation, Grade 4, n=70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol direct, Grade 1, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol direct, Grade 2, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol direct, Grade 3, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LDL cholesterol direct, Grade 4, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lipase, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Lipase, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Lipase, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lipase, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Grade 1, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Grade 2, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Grade 3, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Grade 4, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Grade 1, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Grade 2, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Grade 3, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Grade 4, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Grade 1, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Grade 2, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Grade 3, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Grade 4, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Weeks 48 to 432', 'description': 'Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety - Continuation Phase Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Hemoglobin, Grade 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes, Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Grade 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Grade 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'Hemoglobin, Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Grade 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Weeks 48 to 432', 'description': 'Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety - Continuation Phase Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Weeks 48 to 432', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety - Continuation Phase Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'BSAP, Week 24, n=219, 207', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '3.934', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '5.962', 'groupId': 'OG001'}]}]}, {'title': 'BSAP, Week 48, n=202, 184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.64', 'spread': '5.746', 'groupId': 'OG000'}, {'value': '7.60', 'spread': '7.144', 'groupId': 'OG001'}]}]}, {'title': 'Osteocalcin, Week 24, n=209, 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.73', 'spread': '7.484', 'groupId': 'OG000'}, {'value': '14.38', 'spread': '22.205', 'groupId': 'OG001'}]}]}, {'title': 'Osteocalcin, Week 48, n=194, 178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.15', 'spread': '9.018', 'groupId': 'OG000'}, {'value': '16.30', 'spread': '25.043', 'groupId': 'OG001'}]}]}, {'title': 'PTP, Week 24, n=223, 206', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '20.11', 'groupId': 'OG000'}, {'value': '32.0', 'spread': '27.89', 'groupId': 'OG001'}]}]}, {'title': 'PTP, Week 48, n=205, 186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '23.05', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '27.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Weeks 24 and 48', 'description': 'Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Micrograms per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 24, n=221, 207', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.8', 'spread': '173.09', 'groupId': 'OG000'}, {'value': '272.4', 'spread': '205.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=202, 185', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.9', 'spread': '173.73', 'groupId': 'OG000'}, {'value': '267.9', 'spread': '200.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Weeks 24 and 48', 'description': 'Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Nanograms per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Vitamin D, Week 24, n=223, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '24.95', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '31.66', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D, Week 48, n=206, 186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '20.63', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '23.78', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D2, Week 24, n=223, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '7.88', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D2, Week 48, n=206, 186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '11.00', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D3, Week 24, n=223, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '24.33', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '31.39', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D3, Week 48, n=206, 186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '20.56', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '21.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Weeks 24 and 48', 'description': 'Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.', 'unitOfMeasure': 'Nanomoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'BSAP, n=202, 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.188', 'groupId': 'OG000', 'lowerLimit': '1.135', 'upperLimit': '1.243'}, {'value': '1.629', 'groupId': 'OG001', 'lowerLimit': '1.553', 'upperLimit': '1.708'}]}]}, {'title': 'PTP, n=202, 184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.214', 'groupId': 'OG000', 'lowerLimit': '1.158', 'upperLimit': '1.272'}, {'value': '1.752', 'groupId': 'OG001', 'lowerLimit': '1.668', 'upperLimit': '1.840'}]}]}, {'title': 'Osteocalcin, n=194, 178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.282', 'groupId': 'OG000', 'lowerLimit': '1.214', 'upperLimit': '1.354'}, {'value': '2.039', 'groupId': 'OG001', 'lowerLimit': '1.926', 'upperLimit': '2.159'}]}]}, {'title': 'Type 1 Collagen C-Telopeptide, n=202, 184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.257', 'groupId': 'OG000', 'lowerLimit': '1.195', 'upperLimit': '1.323'}, {'value': '1.918', 'groupId': 'OG001', 'lowerLimit': '1.819', 'upperLimit': '2.023'}]}]}, {'title': 'Vitamin D, n=206, 186', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.987', 'groupId': 'OG000', 'lowerLimit': '0.940', 'upperLimit': '1.036'}, {'value': '1.158', 'groupId': 'OG001', 'lowerLimit': '1.101', 'upperLimit': '1.219'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.729', 'ciLowerLimit': '0.683', 'ciUpperLimit': '0.779', 'estimateComment': 'BSAP ratio of Week 48 result over Baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.693', 'ciLowerLimit': '0.647', 'ciUpperLimit': '0.741', 'estimateComment': 'PTP ratio of Week 48 result over Baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.629', 'ciLowerLimit': '0.581', 'ciUpperLimit': '0.680', 'estimateComment': 'Osteocalcin ratio of Week 48 result over Baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.655', 'ciLowerLimit': '0.609', 'ciUpperLimit': '0.706', 'estimateComment': 'Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.852', 'ciLowerLimit': '0.794', 'ciUpperLimit': '0.914', 'estimateComment': 'Vitamin D ratio of Week 48 result over Baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Total Score, Week 48, n=205, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '5.66', 'groupId': 'OG001'}]}]}, {'title': 'MCS, Week 48, n=205, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.397', 'spread': '10.5232', 'groupId': 'OG000'}, {'value': '2.329', 'spread': '9.9782', 'groupId': 'OG001'}]}]}, {'title': 'PCS, Week 48, n=205, 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.905', 'spread': '8.6309', 'groupId': 'OG000'}, {'value': '1.444', 'spread': '8.3938', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': "The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'HIVTSQs Total Score at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Week 4, n=243, 239', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.0', 'spread': '6.37', 'groupId': 'OG000'}, {'value': '51.9', 'spread': '8.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=236, 226', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.1', 'spread': '5.38', 'groupId': 'OG000'}, {'value': '53.6', 'spread': '7.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n=225, 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.8', 'spread': '4.55', 'groupId': 'OG000'}, {'value': '54.3', 'spread': '7.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=206, 191', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.0', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '55.4', 'spread': '6.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Week 4', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Week 12', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Week 24', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Week 48', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 12, 24 and 48', 'description': 'The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'Age, <50 Years, n=212, 212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Age, >=50 Years, n=36, 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Race, White, n=115, 107', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Race, Non-White, n=133,140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Race, African-American/African Heritage, n=102,108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Non-African-American/African Heritage, n=146, 139', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'BPHR, <1000, n=5, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'BPHR, 1000 to <10,000, n=66, 62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'BPHR, 10,000 to <50,000, n=83, 81', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'BPHR, 50,000 to <=100,000, n=25, 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'BPHR, >100,000, n=69, 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'BCCC, <200, n=64, 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'BCCC, >=200, n=184, 198', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'BCCC, <50, n=9, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'BCCC, 50 to <200, n=55, 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'BCCC, 200 to <350, n=66, 74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'BCCC, 350 to <500, n=56, 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'BCCC, >=500, n=62, 59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'CDC category, A, n=210, 208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'CDC category, B, n=27, 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'CDC category, C, n=11, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 subtype: B vs Non-B, B, n=95, 111', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'HIV-1 subtype: B vs Non-B, non-B, n=140, 131', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Argentina, n=24, 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Canada, n=11, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'France, n=7, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Italy, n=17, 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Mexico, n=6, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Portugal, n=4, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Puerto Rico, n=0, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Russia, n=28, 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'South Africa, n=33, 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Spain, n=23, 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Thailand, n=19, 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'USA, n=62, 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'United Kingdom, n=14, 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with plasma HIV-1 RNA \\<50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA \\[BPHR\\], Baseline CD4+ cell count \\[BCCC\\], Baseline Centers for Disease Control and Prevention \\[CDC\\] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =\\<versus \\[vs\\]. \\>100,000 c/mL) and CD4+ cell count (=\\<350 cells/mm\\^3 or \\>350 cells/mm\\^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'OG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}], 'classes': [{'title': 'CDC Class A to CDC Class C', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'CDC Class B to CDC Class C', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CDC Class C to new CDC Class C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'CDC Class A, B or C to Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 48', 'description': 'Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD', 'description': 'Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants who completed 48 weeks of treatment, continued to receive DTG/ABC/3TC in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'CDC Class A to CDC Class C', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'CDC Class B to CDC Class C', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CDC Class C to new CDC Class C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CDC Class A, B or C to Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 432', 'description': 'Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD', 'description': 'Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants who completed 48 weeks of treatment, continued to receive DTG/ABC/3TC in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'classes': [{'title': 'INSTI; n= 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NNRTI; n=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NRTI; n=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PI; n=8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 432', 'description': 'Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'On-treatment Genotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks during Randomized Phase'}], 'classes': [{'title': 'INSTI; n= 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NNRTI; n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NRTI; n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PI; n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 48', 'description': 'Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'On-treatment Genotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'FG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}, {'id': 'FG002', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase', 'description': 'Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg once daily orally in the Continuation Phase until it was either locally approved or commercial supplies were available.'}], 'periods': [{'title': 'Randomized Phase (Up to 48 Weeks)', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '249'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'ITT-E Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '247'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomized, but did not receive treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Continuation Phase(From Weeks 48 to 432)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '149 participants from the Randomized Phase entered in the Continuation Phase', 'groupId': 'FG002', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.', 'preAssignmentDetails': 'A total of 499 participants were randomized to receive dolutegravir(DTG)/abacavir(ABC)/lamivudine(3TC) fixed dose combination(FDC) or combination of atazanavir(ATV), Ritonavir(RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine(TDF/FTC). Two participants from each DTG/ABC/3TC and ATV+RTV+TDF/FTC groups were randomized but not treated. A total of 495 participants received at least single dose of investigational products(IP) and were included in Intent-to-Treat Exposed(ITT-E) Population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '495', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase', 'description': 'Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.'}, {'id': 'BG001', 'title': 'ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase', 'description': 'Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '11.15', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '10.14', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '10.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '495', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': 'American Indian Or Alaskan Native', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian Or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristic data are reported for members of the ITT-E Population which comprised of all randomized participants who received at least one dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-19', 'size': 1795354, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-17T03:55', 'hasProtocol': True}, {'date': '2022-08-19', 'size': 2451773, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-17T03:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 499}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2013-07-25', 'resultsFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-13', 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \\<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\\<vs. \\>100,000 c/mL) and CD4+ cell count (=\\<350 cells per millimeter cube (cells/mm\\^3) or \\>350 cells/mm\\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Percentage of participants with plasma HIV-1 RNA \\<50 and \\<400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off.'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase', 'timeFrame': 'Week 96 and Week 432', 'description': 'Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \\<50 c/mL were reported. Percentage values are rounded off.'}, {'measure': 'Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase', 'timeFrame': 'Baseline (Day 1), Week 96 and Week 432', 'description': 'Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.'}, {'measure': 'Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase', 'timeFrame': 'Week 96 and Week 432', 'description': 'Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase', 'timeFrame': 'Baseline (Day 1), Week 96, Week 432', 'description': 'Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.'}, {'measure': 'Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase', 'timeFrame': 'Week 96 and Week 432', 'description': 'Absolute values in CD4+ cell count were assessed at indicated time points.'}, {'measure': 'Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol \\[CHLS\\], high density lipoprotein \\[HDL\\] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment.'}, {'measure': 'Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Albumin at Indicated Timepoints', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Creatinine Clearance at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Lipase at Indicated Timepoints', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Erythrocytes at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Hematocrit Count at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48', 'description': 'Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Triglycerides at Week 48', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.'}, {'measure': 'Change From Baseline in TC/HDL Ratio at Week 48', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.'}, {'measure': 'Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points', 'timeFrame': 'Baseline (Day 1), Week 24 and Week 48', 'description': 'Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Number of Participants With AEs by Maximum Toxicity-Randomized Phase', 'timeFrame': 'Up to Week 48', 'description': 'Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.'}, {'measure': 'Number of Participants With AEs by Maximum Toxicity-Continuation Phase', 'timeFrame': 'From Weeks 48 to 432', 'description': 'Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.'}, {'measure': 'Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.'}, {'measure': 'Number of Participants With Any AEs, and SAEs in Continuation Phase', 'timeFrame': 'From Weeks 48 to 432', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.'}, {'measure': 'Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase', 'timeFrame': 'Up to Week 48', 'description': 'Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.'}, {'measure': 'Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase', 'timeFrame': 'From Weeks 48 to 432', 'description': 'Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.'}, {'measure': 'Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase', 'timeFrame': 'Up to Week 48', 'description': 'Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.'}, {'measure': 'Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase', 'timeFrame': 'From Weeks 48 to 432', 'description': 'Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.'}, {'measure': 'Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase', 'timeFrame': 'Up to Week 48', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.'}, {'measure': 'Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase', 'timeFrame': 'From Weeks 48 to 432', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.'}, {'measure': 'Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints', 'timeFrame': 'Baseline (Day 1), Weeks 24 and 48', 'description': 'Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints', 'timeFrame': 'Baseline (Day 1), Weeks 24 and 48', 'description': 'Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48', 'timeFrame': 'Baseline (Day 1), Weeks 24 and 48', 'description': 'Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.'}, {'measure': 'Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': 'Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.'}, {'measure': 'Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS', 'timeFrame': 'Baseline (Day 1) and Week 48', 'description': "The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value."}, {'measure': 'HIVTSQs Total Score at Indicated Timepoints', 'timeFrame': 'Weeks 4, 12, 24 and 48', 'description': 'The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test.'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with plasma HIV-1 RNA \\<50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA \\[BPHR\\], Baseline CD4+ cell count \\[BCCC\\], Baseline Centers for Disease Control and Prevention \\[CDC\\] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =\\<versus \\[vs\\]. \\>100,000 c/mL) and CD4+ cell count (=\\<350 cells/mm\\^3 or \\>350 cells/mm\\^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off.'}, {'measure': 'Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase', 'timeFrame': 'Up to week 48', 'description': 'Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.'}, {'measure': 'Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)', 'timeFrame': 'Up to week 432', 'description': 'Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.'}, {'measure': 'Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)', 'timeFrame': 'Up to week 432', 'description': 'Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.'}, {'measure': 'Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)', 'timeFrame': 'Up to week 48', 'description': 'Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antiretroviral therapy naïve', 'women', 'once daily', 'HIV infection', 'atazanavir', 'tenofovir/emtricitabine', 'dolutegravir/abacavir/lamivudine fixed dose combination', 'integrase inhibitor', 'ritonavir'], 'conditions': ['Infection, Human Immunodeficiency Virus', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '28729158', 'type': 'DERIVED', 'citation': 'Orrell C, Hagins DP, Belonosova E, Porteiro N, Walmsley S, Falco V, Man CY, Aylott A, Buchanan AM, Wynne B, Vavro C, Aboud M, Smith KY; ARIA study team. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Lancet HIV. 2017 Dec;4(12):e536-e546. doi: 10.1016/S2352-3018(17)30095-4. Epub 2017 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-1 infected females (gender at birth) \\>=18 years of age\n* Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)\n* HIV-1 infection as documented by Screening plasma HIV-1 RNA \\>=500 c/mL.\n* Documentation that the subject is negative for the HLA-B\\*5701 allele.\n* Antiretroviral-naïve (\\<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).\n* Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Women who plan to become pregnant during the first 48 weeks of the study\n* Any subject who has had a medical intervention for gender reassignment\n* Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease\n* Subjects with any degree of hepatic impairment\n* Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study\n* History or presence of allergy to the study drugs or their components or drugs of their class\n* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia\n* poses a significant suicidality risk\n* History of osteoporosis with fracture or requiring pharmacologic therapy\n* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening\n* Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses;\n* Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP)\n* Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP\n* Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result\n* Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol)\n* Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound\n* Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \\>35% direct bilirubin)\n* Subject has CrCL of \\<50 mL/min via Cockroft-Gault method\n* Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block."}, 'identificationModule': {'nctId': 'NCT01910402', 'briefTitle': 'A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women', 'orgStudyIdInfo': {'id': '117172'}, 'secondaryIdInfos': [{'id': '2012-005823-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DTG/ABC/3TC FDC', 'description': 'As per the randomization schedule subjects will be administered with DTG/ABC/3TC (50mg/600mg/300mg) FDC tablet OD up to Week 48 and if continued if applicable in the Continuation Phase. DTG/ABC/3TC FDC may be administered with or without food', 'interventionNames': ['Drug: Dolutegravir/abacavir/lamivudine FDC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ATV +RTV +TDF/FTC FDC', 'description': 'As per the randomization schedule subjects will be administered with ATV (300mg capsule) +RTV (100mg tablet) + TDF/FTC (300mg/200mg tablet) FDC OD up to Week 48. ATV+RTV+ TDF/FTC FDC must be taken with food', 'interventionNames': ['Drug: Atazanavir', 'Drug: Ritonavir', 'Drug: Tenofovir/emtricitabine FDC']}], 'interventions': [{'name': 'Dolutegravir/abacavir/lamivudine FDC', 'type': 'DRUG', 'description': 'Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg', 'armGroupLabels': ['DTG/ABC/3TC FDC']}, {'name': 'Atazanavir', 'type': 'DRUG', 'description': 'Atazanavir capsule 300 mg', 'armGroupLabels': ['ATV +RTV +TDF/FTC FDC']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'Ritonavir tablet 100 mg', 'armGroupLabels': ['ATV +RTV +TDF/FTC FDC']}, {'name': 'Tenofovir/emtricitabine FDC', 'type': 'DRUG', 'description': 'Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC', 'armGroupLabels': ['ATV +RTV +TDF/FTC FDC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34982', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33602', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912-3130', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '31401', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '7754', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27401-1209', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '18102', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': 'C1405CKC', 'city': 'Ciudad Autónoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site'}, {'zip': 'C1202ABB', 'city': 'Ciudad de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site'}, {'zip': '1141', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 2P4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '16128', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '24127', 'city': 'Bergamo', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '25123', 'city': 'Brescia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '21052', 'city': 'Busto Arsizio (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.61128, 'lon': 8.84914}}, {'zip': '20127', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20157', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '10149', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '14000', 'city': 'México', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '2720-276', 'city': 'Amadora', 'country': 'Portugal', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '1150', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '00717', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00936', 'city': 'Rio Piedras', 'country': 'Puerto Rico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '115035', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '302040', 'city': 'Oryol', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.96879, 'lon': 36.0791}}, {'zip': '190103', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196645', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '214006', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '445846', 'city': 'Toliyatti', 'country': 'Russia', 'facility': 'GSK Investigational Site'}, {'zip': '7925', 'city': 'Observatory, Cape Town', 'state': 'Western Province', 'country': 'South Africa', 'facility': 'GSK Investigational Site'}, {'zip': '122', 'city': 'Mamelodi East', 'country': 'South Africa', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -25.67912, 'lon': 28.35096}}, {'zip': '28935', 'city': '(Móstoles) Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site'}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30003', 'city': 'Murcia', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '11000', 'city': 'Nonthaburi', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'S10 2JF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SW17 0QT', 'city': 'Tooting, London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'ipdSharingStatementModule': {'url': 'https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.', 'ipdSharing': 'YES', 'description': "Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/", 'accessCriteria': 'Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}