Viewing Study NCT02603120

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Ignite Creation Date: 2025-12-25 @ 4:17 AM
Ignite Modification Date: 2026-02-24 @ 2:30 PM
Study NCT ID: NCT02603120
Status: COMPLETED
Last Update Posted: 2020-11-12
First Post: 2015-11-10
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631408', 'term': 'abacavir, dolutegravir, and lamivudine drug combination'}, {'id': 'C000620396', 'term': 'bictegravir'}, {'id': 'C442442', 'term': 'tenofovir alafenamide'}, {'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose date up to 169 weeks plus 30 days', 'description': 'The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-Blind: B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 282, 'otherNumAffected': 122, 'seriousNumAtRisk': 282, 'deathsNumAffected': 2, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Double-Blind: ABC/DTG/3TC', 'description': 'ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 132, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'Open-label Extension: B/F/TAF From B/F/TAF', 'description': 'Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 84, 'seriousNumAtRisk': 259, 'deathsNumAffected': 1, 'seriousNumAffected': 24}, {'id': 'EG003', 'title': 'Open-label Extension: B/F/TAF From ABC/DTG/3TC', 'description': 'Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 265, 'otherNumAffected': 82, 'seriousNumAtRisk': 265, 'deathsNumAffected': 1, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myocardial bridging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Macular detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cellulitis of male external genital organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Eye infection syphilitic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Large intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lymphadenitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Post procedural sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and 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0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Injury, 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'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 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connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Malignant neoplasm of thymus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Testicular seminoma (pure) stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hemiplegic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Self-injurious ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 259, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'OG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.002', 'paramValue': '0.7', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.8', 'estimateComment': 'The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.'}, {'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'OG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000'}, {'value': '95.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.002', 'paramValue': '-1.4', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '2.6', 'estimateComment': 'The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA \\< 50 copies/mL is greater than -10%.'}, {'pValue': '.59', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'OG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31', 'spread': '181.3', 'groupId': 'OG000'}, {'value': '4', 'spread': '191.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35', 'ciLowerLimit': '-67', 'ciUpperLimit': '-3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Spine Bone Mineral Density (BMD) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'OG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.124', 'spread': '0.1833', 'groupId': 'OG000'}, {'value': '1.103', 'spread': '0.1548', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Spine dual X-ray absorptiometry (DXA) analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Spine BMD at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'OG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.692', 'spread': '3.1296', 'groupId': 'OG000'}, {'value': '0.416', 'spread': '2.9973', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.276', 'ciLowerLimit': '-0.275', 'ciUpperLimit': '0.827', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Spine DXA Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Hip Bone Mineral Density at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'OG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.006', 'spread': '0.1471', 'groupId': 'OG000'}, {'value': '0.996', 'spread': '0.1363', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Hip DXA Analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Hip BMD at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'OG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.156', 'spread': '2.2138', 'groupId': 'OG000'}, {'value': '0.299', 'spread': '2.1077', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.143', 'ciLowerLimit': '-0.534', 'ciUpperLimit': '0.248', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Hip DXA Analysis Set with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) tablet + abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) placebo orally once daily for at least 48 weeks, without regard to food.\n\nOpen-label (OL) Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'FG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}], 'periods': [{'title': 'Double-Blind Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '283'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '267'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Investigator's discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not receive study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'OL Extension B/F/TAF Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '265'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': "Investigator's discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 11 November 2015. The last study visit occurred on 23 October 2019.', 'preAssignmentDetails': '646 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'B/F/TAF', 'description': 'Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'BG001', 'title': 'ABC/DTG/3TC', 'description': 'Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.\n\nOL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '45', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '45', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted = local regulators did not allow collection of race or ethnicity information.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted = local regulators did not allow collection of race or ethnicity information', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV-1 RNA Categories', 'classes': [{'categories': [{'title': '< 50 copies/mL', 'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}, {'title': '≥ 50 copies/mL', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '752', 'spread': '302.2', 'groupId': 'BG000'}, {'value': '694', 'spread': '291.6', 'groupId': 'BG001'}, {'value': '723', 'spread': '298.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cell/µL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Cell Count Category', 'classes': [{'categories': [{'title': '≥ 50 to < 200 cells/μL', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '≥ 200 to < 350 cells/μL', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '≥ 350 to < 500 cells/μL', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': '≥ 500 cells/μL', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-21', 'size': 2205927, 'label': 'Study Protocol: Original', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-24T16:28', 'hasProtocol': True}, {'date': '2016-10-19', 'size': 2708739, 'label': 'Study Protocol: Amendment 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-24T19:10', 'hasProtocol': True}, {'date': '2016-02-19', 'size': 2242403, 'label': 'Study Protocol: Amendment 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_007.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-24T19:12', 'hasProtocol': True}, {'date': '2017-05-08', 'size': 1167169, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_008.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-23T10:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 567}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': 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Week 48', 'timeFrame': 'Baseline; Week 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '31430369', 'type': 'RESULT', 'citation': 'Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347.'}, {'pmid': '29925489', 'type': 'RESULT', 'citation': 'Molina JM, Ward D, Brar I, Mills A, Stellbrink HJ, Lopez-Cortes L, Ruane P, Podzamczer D, Brinson C, Custodio J, Liu H, Andreatta K, Martin H, Cheng A, Quirk E. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e357-e365. doi: 10.1016/S2352-3018(18)30092-4. Epub 2018 Jun 18.'}, {'pmid': '39993074', 'type': 'DERIVED', 'citation': 'Brar I, Ruane PJ, Berhe M, Brinson C, Benson P, Henry K, Liu H, Andreatta K, Hindman JT, Ramgopal M. Efficacy and safety of switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir/abacavir/lamivudine: Results from an open-label extension of a phase 3 randomized, double-blind, multicenter, active-controlled, non-inferiority study. Medicine (Baltimore). 2025 Feb 21;104(8):e41482. doi: 10.1097/MD.0000000000041482.'}, {'pmid': '36912172', 'type': 'DERIVED', 'citation': 'Avihingsanon A, Chetchotisakd P, Kiertiburanakul S, Ratanasuwan W, Siripassorn K, Supparatpinyo K, Martin H, Wang H, Wong T, Wang HY. Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. HIV Med. 2023 Mar;24(3):290-300. doi: 10.1111/hiv.13386. Epub 2022 Aug 17.'}, {'pmid': '29956087', 'type': 'DERIVED', 'citation': 'Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).\n* Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.\n* HIV ribonucleic acid (RNA) \\< 50 copies/mL at the screening 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