Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-06-02 @ 5:22 PM
Study NCT ID:
NCT02720094
Status:
COMPLETED
Last Update Posted:
2025-10-10
First Post:
2016-03-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584914', 'term': 'cabotegravir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HPTN-Data-Access@scharp.org', 'phone': '206-667-4004', 'title': 'HPTN Statistical Manager', 'organization': 'HPTN Statistical & Data Management Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Treatment-emergent AE measured with onset date through participant's last study visit (up to 48 weeks after the last injection visit), or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks)", 'description': 'Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.', 'eventGroups': [{'id': 'EG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. Cabotegravir tablets: 30 mg tablets TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets TDF/FTC placebo tablets CAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter', 'otherNumAtRisk': 2281, 'deathsNumAtRisk': 2281, 'otherNumAffected': 2103, 'seriousNumAtRisk': 2281, 'deathsNumAffected': 4, 'seriousNumAffected': 117}, {'id': 'EG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks. TDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets CAB placebo tablets Placebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter', 'otherNumAtRisk': 2285, 'deathsNumAtRisk': 2285, 'otherNumAffected': 2114, 'seriousNumAtRisk': 2285, 'deathsNumAffected': 7, 'seriousNumAffected': 109}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Antiphospholipid syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 40, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cyclic neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphocytic infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': "Gilbert's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Steatocystoma multiplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thalassaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ear swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tympanic membrane disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chorioretinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Eye allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Eye inflammation', 'stats': 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'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Extranodal marginal zone B-cell lymphoma (MALT type)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastatic carcinoma of the bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Adjustment disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 32, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Borderline personality disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Impulse-control disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Substance-induced psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2281, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2285, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Documented Incident HIV Infections During Steps 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2280', 'groupId': 'OG000'}, {'value': '2281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'A bias-adjusted hazard ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.340', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.62', 'estimateComment': 'The bias-adjusted hazard ratio, CI, and p-value account for the group-sequential trial design and the early stopping time.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.328', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.61', 'estimateComment': 'The unadjusted hazard ratio is based on a Cox proportional hazards model stratified by region.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.', 'description': 'All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population (Steps 1 and 2): Participants who were inappropriately enrolled are excluded. Participants who were found by the EAC to be HIV infected at enrollment are excluded.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2280', 'groupId': 'OG000'}, {'value': '2282', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '2106', 'groupId': 'OG000'}, {'value': '2116', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).", 'description': 'The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Documented Incident HIV Infections in Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2114', 'groupId': 'OG000'}, {'value': '2079', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.210', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.45', 'pValueComment': 'The P-Values are two-sided.', 'groupDescription': 'The analysis population Injection Step 2 Efficacy consists of the subset of the mITT population who received at least one injection and had at least one HIV test result after the week 5 injection visit.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.', 'description': 'Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Injection step 2 efficacy: The subgroup of the mITT population who received at least one injection and had at least one HIV result assessed after the first injection visit.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Creatinine and Creatinine Clearance Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1364', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Week 57 (Injection #8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1364', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '-5.30', 'upperLimit': '7.10'}, {'value': '1.70', 'groupId': 'OG001', 'lowerLimit': '-4.40', 'upperLimit': '7.90'}]}]}, {'title': 'Week 105 (Injection #14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '-5.30', 'upperLimit': '8.80'}, {'value': '2.30', 'groupId': 'OG001', 'lowerLimit': '-3.50', 'upperLimit': '8.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Reported week 57 (injection visit #8) and week 105 (injection visit #14)', 'description': 'Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study product, and for whom have results for creatine and creatinine clearance at enrollment AND for at least one of the following two time points: Week 57 and Week 105.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2280', 'groupId': 'OG000'}, {'value': '2282', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)", 'description': 'Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.'}, {'type': 'SECONDARY', 'title': 'Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Any resistance', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'PI resistance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NNRTI resistance', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'NRTI resistance', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'INSTI resistance', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center', 'description': 'Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the mITT population who acquired HIV, including those who were found to have acquired HIV prior to randomization.'}, {'type': 'SECONDARY', 'title': 'Changes in Weight From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2282', 'groupId': 'OG000'}, {'value': '2284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Week 5 (Injection #1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}, {'value': '2078', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '1.5'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Week 9 (Injection #2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2038', 'groupId': 'OG000'}, {'value': '2012', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '1.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '1.3'}]}]}, {'title': 'Week 17 (Injection #3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1941', 'groupId': 'OG000'}, {'value': '1943', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '2.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '1.6'}]}]}, {'title': 'Week 25 (Injection #4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1876', 'groupId': 'OG000'}, {'value': '1875', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '2.7'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '1.8'}]}]}, {'title': 'Week 33 (Injection #5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1764', 'groupId': 'OG000'}, {'value': '1765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '1.9'}]}]}, {'title': 'Week 41 (Injection #6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1625', 'groupId': 'OG000'}, {'value': '1613', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '3.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '2.4'}]}]}, {'title': 'Week 49 (Injection #7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}, {'value': '1464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '3.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '2.6'}]}]}, {'title': 'Week 57 (Injection #8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1362', 'groupId': 'OG000'}, {'value': '1361', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '4.0'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '2.5'}]}]}, {'title': 'Week 65 (Injection #9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'OG000'}, {'value': '1197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '4.5'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '3.1'}]}]}, {'title': 'Week #73 (Injection #10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '5.0'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '3.3'}]}]}, {'title': 'Week 81 (Injection #11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '881', 'groupId': 'OG000'}, {'value': '905', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '5.2'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '3.9'}]}]}, {'title': 'Week 89 (Injection #12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'OG000'}, {'value': '761', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '5.8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '3.9'}]}]}, {'title': 'Week 97 (Injection #13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '600', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '5.9'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '4.0'}]}]}, {'title': 'Week #105 (Injection #14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '6.3'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '4.8'}]}]}, {'title': 'Week 113 (Injection #15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '7.2'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '5.3'}]}]}, {'title': 'Week 121 (Injection #16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '7.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '5.1'}]}]}, {'title': 'Week 129 (Injection #17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '7.1'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '4.8'}]}]}, {'title': 'Week 137 (Injection #18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '7.8'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '5.2'}]}]}, {'title': 'Week 145 (Injection #19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '7.3'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '5.4'}]}]}, {'title': 'Week 153 (Injection #20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '7.5'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).', 'description': 'Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants with available data at each visit'}, {'type': 'SECONDARY', 'title': 'Changes in Systolic Blood Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2281', 'groupId': 'OG000'}, {'value': '2285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Week 5 (Injection #1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2110', 'groupId': 'OG000'}, {'value': '2074', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 9 (Injection #2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2038', 'groupId': 'OG000'}, {'value': '2011', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '7.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 17 (Injection #3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1938', 'groupId': 'OG000'}, {'value': '1943', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 25 (Injection #4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1875', 'groupId': 'OG000'}, {'value': '1874', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 33 (Injection #5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1761', 'groupId': 'OG000'}, {'value': '1764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 41 (Injection #6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1623', 'groupId': 'OG000'}, {'value': '1609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 49 (Injection #7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1465', 'groupId': 'OG000'}, {'value': '1464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 57 (Injection #8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1360', 'groupId': 'OG000'}, {'value': '1359', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '8.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-10.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 65 (Injection #9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'OG000'}, {'value': '1195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 73 (Injection #10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1035', 'groupId': 'OG000'}, {'value': '1036', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 81 (Injection #11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '879', 'groupId': 'OG000'}, {'value': '902', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '8.0'}]}]}, {'title': 'Week 89 (Injection #12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'OG000'}, {'value': '759', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '9.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 97 (Injection #13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '602', 'groupId': 'OG000'}, {'value': '600', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 105 (Injection #14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '8.0'}]}]}, {'title': 'Week 113 (Injection #15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '8.0'}]}]}, {'title': 'Week 121 (Injection #16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '9.0'}]}]}, {'title': 'Week 129 (Injection #17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '10.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '11.0'}]}]}, {'title': 'Week 137 (Injection #18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '9.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 145 (Injection #19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '11.0'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 153 (Injection #20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '9.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '13.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).', 'description': 'Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.'}, {'type': 'SECONDARY', 'title': 'Changes in Diastolic Blood Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2281', 'groupId': 'OG000'}, {'value': '2285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Week 5 (Injection #1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2110', 'groupId': 'OG000'}, {'value': '2074', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '4.0'}]}]}, {'title': 'Week 9 (Injection #2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2038', 'groupId': 'OG000'}, {'value': '2011', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '4.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 17 (Injection #3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1938', 'groupId': 'OG000'}, {'value': '1943', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 25 (Injection #4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1875', 'groupId': 'OG000'}, {'value': '1873', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 33 (Injection #5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1761', 'groupId': 'OG000'}, {'value': '1764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 41 (Injection #6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1623', 'groupId': 'OG000'}, {'value': '1609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 49 (Injection #7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1465', 'groupId': 'OG000'}, {'value': '1464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 57 (Injection #8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1360', 'groupId': 'OG000'}, {'value': '1359', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 65 (Injection #9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'OG000'}, {'value': '1195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 73 (Injection #10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1035', 'groupId': 'OG000'}, {'value': '1036', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 81 (Injection #11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '879', 'groupId': 'OG000'}, {'value': '902', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '6.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 89 (Injection #12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'OG000'}, {'value': '759', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 97 (Injection #13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '602', 'groupId': 'OG000'}, {'value': '600', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '6.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 105 (Injection #14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 113 (Injection #15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 121 (Injection #16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '6.5'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 129 (Injection #17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 137 (Injection #18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 145 (Injection #19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '8.0'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '5.0'}]}]}, {'title': 'Week 153 (Injection #20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).', 'description': 'Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.'}, {'type': 'SECONDARY', 'title': 'Changes in Pulse Rate From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2281', 'groupId': 'OG000'}, {'value': '2285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Week 5 (Injection #1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2110', 'groupId': 'OG000'}, {'value': '2075', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '9.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '8.0'}]}]}, {'title': 'Week 9 (Injection #2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2038', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '9.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '8.0'}]}]}, {'title': 'Week 17 (Injection #3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1945', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '9.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '9.0'}]}]}, {'title': 'Week 25 (Injection #4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1873', 'groupId': 'OG000'}, {'value': '1873', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '9.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '9.0'}]}]}, {'title': 'Week 33 (Injection #5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1761', 'groupId': 'OG000'}, {'value': '1764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '10.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '9.0'}]}]}, {'title': 'Week 41 (Injection #6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1623', 'groupId': 'OG000'}, {'value': '1608', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '10.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '9.0'}]}]}, {'title': 'Week 49 (Injection #7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1465', 'groupId': 'OG000'}, {'value': '1464', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '10.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 57 (Injection #8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1360', 'groupId': 'OG000'}, {'value': '1358', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 65 (Injection #9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1207', 'groupId': 'OG000'}, {'value': '1195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '10.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 73 (Injection #10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}, {'value': '1036', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '11.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 81 (Injection #11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '878', 'groupId': 'OG000'}, {'value': '902', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '11.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 89 (Injection #12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}, {'value': '759', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '11.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 97 (Injection #13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '602', 'groupId': 'OG000'}, {'value': '600', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '12.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '11.0'}]}]}, {'title': 'Week 105 (Injection #14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '461', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '9.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 113 (Injection #15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '11.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 121 (Injection #16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '12.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '11.0'}]}]}, {'title': 'Week 129 (Injection #17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '11.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 137 (Injection #18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '12.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '10.0'}]}]}, {'title': 'Week 145 (Injection #19)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '13.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '11.0'}]}]}, {'title': 'Week 153 (Injection #20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '12.0'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).', 'description': 'Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Glucose Levels From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2282', 'groupId': 'OG000'}, {'value': '2284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Week 57', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '6.0'}]}]}, {'title': 'Week 105', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '8.0'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at weeks 57 and 105.', 'description': 'Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were inappropriately enrolled are excluded. Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Lipid Profile From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2282', 'groupId': 'OG000'}, {'value': '2284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'classes': [{'title': 'Total Cholesterol Week 57', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-15.0', 'upperLimit': '16.0'}, {'value': '-10.0', 'groupId': 'OG001', 'lowerLimit': '-26.0', 'upperLimit': '6.2'}]}]}, {'title': 'Total Cholesterol Week 105', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-13.0', 'upperLimit': '19.0'}, {'value': '-7.5', 'groupId': 'OG001', 'lowerLimit': '-26.0', 'upperLimit': '9.0'}]}]}, {'title': 'Trigylcerides Week 57', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '-20.0', 'upperLimit': '28.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-23.0', 'upperLimit': '25.0'}]}]}, {'title': 'Trigylcerides Week 105', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '-19.0', 'upperLimit': '32.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-21.0', 'upperLimit': '31.0'}]}]}, {'title': 'LDL Week 57', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-12.4', 'upperLimit': '15.0'}, {'value': '-6.0', 'groupId': 'OG001', 'lowerLimit': '-19.7', 'upperLimit': '7.0'}]}]}, {'title': 'LDL Week 105', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '18.0'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-20.0', 'upperLimit': '11.0'}]}]}, {'title': 'HDL Week57', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '5.0'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '3.0'}]}]}, {'title': 'HDL Week 105', 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '5.0'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '2.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at weeks 57 and 105.', 'description': 'Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral cabotegravir (CAB) and daily oral Tenofovir/emtricitabine (TDF/FTC) placebo for 5 weeks. In Step 2, participants will receive long-acting injectable cabotegravir (CAB LA) and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'FG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral Tenofovir/emtricitabine (TDF/FTC) and daily oral cabotegravir (CAB) placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for long-acting injectable cabotegravir (CAB LA) to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2283'}, {'groupId': 'FG001', 'numSubjects': '2287'}]}, {'type': 'Ongoing', 'comment': 'Ongoing in the study indicates the participant has not terminated study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2210'}, {'groupId': 'FG001', 'numSubjects': '2203'}]}, {'type': 'Terminated From the Study', 'comment': 'Excludes participants who completed the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'comment': 'Completed the study indicates a participant has seroconverted or has entered Step 3 after reaching Week 145 visit and was subsequently followed for 48 weeks in Step 3 without prior IP discontinuation or study termination or has entered Step 3 after discontinuation of IP and was subsequently followed for 48 weeks and was followed for a total of 3 years from enrollment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2276'}, {'groupId': 'FG001', 'numSubjects': '2281'}]}], 'dropWithdraws': [{'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2210'}, {'groupId': 'FG001', 'numSubjects': '2203'}]}, {'type': 'Scheduled exit visit/end of study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Inappropriate enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2283', 'groupId': 'BG000'}, {'value': '2287', 'groupId': 'BG001'}, {'value': '4570', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cabotegravir', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nCabotegravir tablets: 30 mg tablets\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nTDF/FTC placebo tablets\n\nCAB LA: Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'BG001', 'title': 'TDF/FTC', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.\n\nTDF/FTC tablets: 300 mg/200 mg fixed-dose combination tablets\n\nCAB placebo tablets\n\nPlacebo for CAB LA: Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '8.17', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '8.14', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '8.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '32'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '32'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '18-24 years', 'categories': [{'measurements': [{'value': '931', 'groupId': 'BG000'}, {'value': '915', 'groupId': 'BG001'}, {'value': '1846', 'groupId': 'BG002'}]}]}, {'title': '25-34 years', 'categories': [{'measurements': [{'value': '940', 'groupId': 'BG000'}, {'value': '931', 'groupId': 'BG001'}, {'value': '1871', 'groupId': 'BG002'}]}]}, {'title': '35-44 years', 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '598', 'groupId': 'BG002'}]}]}, {'title': '45-54 years', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}]}, {'title': '55-60 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': '61+ years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '<30 years', 'categories': [{'measurements': [{'value': '1572', 'groupId': 'BG000'}, {'value': '1510', 'groupId': 'BG001'}, {'value': '3082', 'groupId': 'BG002'}]}]}, {'title': '>=30 years', 'categories': [{'measurements': [{'value': '711', 'groupId': 'BG000'}, {'value': '777', 'groupId': 'BG001'}, {'value': '1488', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Men who have sex with men', 'categories': [{'measurements': [{'value': '2014', 'groupId': 'BG000'}, {'value': '1982', 'groupId': 'BG001'}, {'value': '3996', 'groupId': 'BG002'}]}]}, {'title': 'Transgender women', 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1043', 'groupId': 'BG000'}, {'value': '1067', 'groupId': 'BG001'}, {'value': '2110', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1240', 'groupId': 'BG000'}, {'value': '1219', 'groupId': 'BG001'}, {'value': '2459', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity categories as defined by the National Institutes of Health and the Office of Management and Budget', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '616', 'groupId': 'BG000'}, {'value': '600', 'groupId': 'BG001'}, {'value': '1216', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '417', 'groupId': 'BG000'}, {'value': '406', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '565', 'groupId': 'BG000'}, {'value': '569', 'groupId': 'BG001'}, {'value': '1134', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '618', 'groupId': 'BG000'}, {'value': '649', 'groupId': 'BG001'}, {'value': '1267', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}]}, {'title': 'Vietnam', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '850', 'groupId': 'BG000'}, {'value': '851', 'groupId': 'BG001'}, {'value': '1701', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '401', 'groupId': 'BG001'}, {'value': '796', 'groupId': 'BG002'}]}]}, {'title': 'Africa', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '416', 'groupId': 'BG000'}, {'value': '416', 'groupId': 'BG001'}, {'value': '832', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Geographical regions and their representative countries are classified as: United States (U.S.), Latin America (Argentina, Brazil and Peru), Asia (Vietnam and Thailand), Africa (South Africa)', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Married/Civil Union/Legal Partnership', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}, {'title': 'Living with Primary or Main Partner', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}]}, {'title': 'Have Primary or Main Partner, not Living Together', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}]}, {'title': 'Single/Divorced/Widowed', 'categories': [{'measurements': [{'value': '1889', 'groupId': 'BG000'}, {'value': '1865', 'groupId': 'BG001'}, {'value': '3754', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'title': 'No Schooling', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Primary School, not complete', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Primary School, complete', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Secondary School, not complete', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}]}, {'title': 'Secondary School, complete', 'categories': [{'measurements': [{'value': '371', 'groupId': 'BG000'}, {'value': '410', 'groupId': 'BG001'}, {'value': '781', 'groupId': 'BG002'}]}]}, {'title': 'Technical Training, not complete', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': 'Technical Training, complete', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}, {'title': 'College/University or Higher, not complete', 'categories': [{'measurements': [{'value': '708', 'groupId': 'BG000'}, {'value': '712', 'groupId': 'BG001'}, {'value': '1420', 'groupId': 'BG002'}]}]}, {'title': 'College/University or Higher, complete', 'categories': [{'measurements': [{'value': '868', 'groupId': 'BG000'}, {'value': '816', 'groupId': 'BG001'}, {'value': '1684', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-31', 'size': 2527263, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-02T17:25', 'hasProtocol': True}, {'date': '2020-10-02', 'size': 691895, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-02T17:38', 'hasProtocol': False}, {'date': '2019-10-31', 'size': 273147, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-27T16:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4570}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2016-03-21', 'resultsFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-11-21', 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Documented Incident HIV Infections During Steps 1 and 2', 'timeFrame': 'HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.', 'description': 'All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).'}, {'measure': 'Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events', 'timeFrame': "Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).", 'description': 'The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Documented Incident HIV Infections in Step 2', 'timeFrame': 'HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.', 'description': 'Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population'}, {'measure': 'Changes From Baseline in Creatinine and Creatinine Clearance Levels', 'timeFrame': 'Reported week 57 (injection visit #8) and week 105 (injection visit #14)', 'description': 'Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit.'}, {'measure': 'Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs)', 'timeFrame': "Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)", 'description': 'Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus.'}, {'measure': 'Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters', 'timeFrame': 'Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center', 'description': 'Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection.'}, {'measure': 'Changes in Weight From Baseline', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).', 'description': 'Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit.'}, {'measure': 'Changes in Systolic Blood Pressure From Baseline', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).', 'description': 'Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.'}, {'measure': 'Changes in Diastolic Blood Pressure From Baseline', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).', 'description': 'Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.'}, {'measure': 'Changes in Pulse Rate From Baseline', 'timeFrame': 'Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).', 'description': 'Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit.'}, {'measure': 'Changes in Fasting Glucose Levels From Baseline', 'timeFrame': 'Assessed at weeks 57 and 105.', 'description': 'Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.'}, {'measure': 'Changes in Fasting Lipid Profile From Baseline', 'timeFrame': 'Assessed at weeks 57 and 105.', 'description': 'Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pre-Exposure Prophylaxis', 'PrEP'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '40590452', 'type': 'DERIVED', 'citation': 'Brown TT, Arao RF, Warsi M, Phanuphak N, Vasconcelos R, Oyedele T, Sullivan PA, Hanscom B, Rooney JF, Rinehart AR, McCauley M, Grinsztejn B, Landovitz RJ. Bone Changes With Long-Acting Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention in Cisgender Men and Transgender Women: HPTN 083. Clin Infect Dis. 2025 Jul 1:ciaf221. doi: 10.1093/cid/ciaf221. Online ahead of print.'}, {'pmid': '38783534', 'type': 'DERIVED', 'citation': 'Psaros C, Goodman GR, Lee JS, Rice W, Kelley CF, Oyedele T, Coelho LE, Phanuphak N, Singh Y, Middelkoop K, Griffith S, McCauley M, Rooney J, Rinehart AR, Clark J, Go V, Sugarman J, Fields SD, Adeyeye A, Grinsztejn B, Landovitz RJ, Safren SA; HPTN 083-02 Study Team. HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study. J Int AIDS Soc. 2024 May;27(5):e26252. doi: 10.1002/jia2.26252.'}, {'pmid': '38709006', 'type': 'DERIVED', 'citation': 'Han K, Patel P, McCallister S, Rinehart AR, Gandhi Y, Spreen W, Landovitz RJ, Delany-Moretlwe S, Marzinke MA, McKeon T, Budnik P, van Wyk J, Ford SL. Long-acting cabotegravir pharmacokinetics with and without oral lead-in for HIV PrEP. Antimicrob Agents Chemother. 2024 Jun 5;68(6):e0147523. doi: 10.1128/aac.01475-23. Epub 2024 May 6.'}, {'pmid': '37952550', 'type': 'DERIVED', 'citation': 'Landovitz RJ, Hanscom BS, Clement ME, Tran HV, Kallas EG, Magnus M, Sued O, Sanchez J, Scott H, Eron JJ, Del Rio C, Fields SD, Marzinke MA, Eshleman SH, Donnell D, Spinelli MA, Kofron RM, Berman R, Piwowar-Manning EM, Richardson PA, Sullivan PA, Lucas JP, Anderson PL, Hendrix CW, Adeyeye A, Rooney JF, Rinehart AR, Cohen MS, McCauley M, Grinsztejn B; HPTN 083 Study Team. Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial. Lancet HIV. 2023 Dec;10(12):e767-e778. doi: 10.1016/S2352-3018(23)00261-8. Epub 2023 Nov 9.'}, {'pmid': '37783219', 'type': 'DERIVED', 'citation': 'Marzinke MA, Hanscom B, Wang Z, Safren SA, Psaros C, Donnell D, Richardson PA, Sullivan P, Eshleman SH, Jennings A, Feliciano KG, Jalil E, Coutinho C, Cardozo N, Maia B, Khan T, Singh Y, Middelkoop K, Franks J, Valencia J, Sanchez N, Lucas J, Rooney JF, Rinehart AR, Ford S, Adeyeye A, Cohen MS, McCauley M, Landovitz RJ, Grinsztejn B; HPTN 083 study group. Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial. Lancet HIV. 2023 Nov;10(11):e703-e712. doi: 10.1016/S2352-3018(23)00200-X. Epub 2023 Sep 29.'}, {'pmid': '34379922', 'type': 'DERIVED', 'citation': 'Landovitz RJ, Donnell D, Clement ME, Hanscom B, Cottle L, Coelho L, Cabello R, Chariyalertsak S, Dunne EF, Frank I, Gallardo-Cartagena JA, Gaur AH, Gonzales P, Tran HV, Hinojosa JC, Kallas EG, Kelley CF, Losso MH, Madruga JV, Middelkoop K, Phanuphak N, Santos B, Sued O, Valencia Huamani J, Overton ET, Swaminathan S, Del Rio C, Gulick RM, Richardson P, Sullivan P, Piwowar-Manning E, Marzinke M, Hendrix C, Li M, Wang Z, Marrazzo J, Daar E, Asmelash A, Brown TT, Anderson P, Eshleman SH, Bryan M, Blanchette C, Lucas J, Psaros C, Safren S, Sugarman J, Scott H, Eron JJ, Fields SD, Sista ND, Gomez-Feliciano K, Jennings A, Kofron RM, Holtz TH, Shin K, Rooney JF, Smith KY, Spreen W, Margolis D, Rinehart A, Adeyeye A, Cohen MS, McCauley M, Grinsztejn B; HPTN 083 Study Team. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. N Engl J Med. 2021 Aug 12;385(7):595-608. doi: 10.1056/NEJMoa2101016.'}, {'pmid': '32497490', 'type': 'DERIVED', 'citation': 'Scarsi KK. Chasing the cabotegravir tail: implications for prevention. Lancet HIV. 2020 Jul;7(7):e451-e453. doi: 10.1016/S2352-3018(20)30165-X. Epub 2020 Jun 1. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).', 'detailedDescription': "The purpose of this study is to evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).\n\nThis study will enroll HIV-uninfected MSM and TGW at risk for acquiring HIV infection. Participants will be followed for a total of 4 years.\n\nThis study will take place in three steps. Participants will be randomly assigned to one of two arms:\n\nArm A:\n\nStep 1: Participants will receive daily oral CAB tablets and daily oral TDF/FTC placebo tablets for 5 weeks.\n\nStep 2: Participants will receive an intramuscular (IM) injection of CAB LA at two time points 4 weeks apart and every 8 weeks thereafter and daily oral TDF/FTC placebo tablets to Week 153.\n\nArm B:\n\nStep 1: Participants will receive daily oral TDF/FTC tablets and daily oral CAB placebo tablets for 5 weeks.\n\nStep 2: Participants will receive daily oral TDF/FTC tablets and an IM injection of placebo at two time points 4 weeks apart and every 8 weeks thereafter to Week 153.\n\nIn Step 3, all participants (Arms A and B) will receive daily oral TDF/FTC tablets starting at Week 153 (last day of Step 2)/Day 0 (first day of Step 3) and continue for 48 weeks.\n\nParticipants will attend up to 47 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, an electrocardiogram (ECG), and rectal swab collection. Some participants may have a bone mineral density-energy x-ray absorptimetry (DXA) scan at select visits.\n\nAll participants will be transitioned to locally available HIV prevention services, including services for PrEP, if available, at the end of their participation in the study.\n\nHPTN 083-01 is a sub-study of HPTN 083. The purpose of this study is to evaluate the safety, tolerability, and acceptability of CAB LA for the prevention of HIV among adolescent males. Participants will receive oral CAB for 5 weeks, followed by 29 weeks on CAB LA, then quarterly visits for 48 weeks after final injection. All participants who have received at least one injection will be followed for 48 weeks after their last injection. Total study duration per participant will be approximately 21 months.\n\nHPTN 083-02 is a qualitative sub-study of participants enrolled in HPTN 083. The purpose of this study is to explore potential barriers, facilitators, and potentially modifiable issues related to adherence to clinic visits in the context of injectable PrEP; to learn about preferences and decision making regarding the use of oral versus injectable PrEP, or other biomedical prevention products; and to gather explanatory qualitative data regarding participants' experiences in HPTN 083 to better interpret study results and guide next prevention strategies. Participants in this sub-study will complete one individual semi-structured qualitative interview."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MSM and TGW, 18 years or older at the time of screening (male at birth)\n* Willing to provide informed consent for the study\n* At high risk for sexually acquiring HIV infection based on self-report of at least one of the following:\n\n * Any condomless receptive anal intercourse in the 6 months prior to enrollment (condomless anal intercourse within a monogamous HIV seronegative concordant relationship does not meet this criterion)\n * More than five partners in the 6 months prior to enrollment (regardless of condom use and HIV serostatus, as reported by the enrollee)\n * Any stimulant drug use in the 6 months prior to enrollment\n * Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to enrollment\n * SexPro score of less than or equal to 16 (U.S. sites only)\n* In general good health, as evidenced by the following laboratory values, which must be from specimens obtained within 45 days prior to study enrollment:\n\n * Non-reactive / negative HIV test results. More information on this criterion can be found in the protocol.\n * Hemoglobin greater than 11 g/dL,\n * Absolute neutrophil count greater than 750 cells/mm\\^3\n * Platelet count greater than or equal to 100,000/mm\\^3\n * Calculated creatinine clearance greater than or equal to 60 mL/minute using the Cockcroft-Gault equation (use sex at birth for calculation)\n\n * Although not protocol exclusionary, sites should carefully consider the advisability of enrolling participants with calculated creatinine clearance between 60-70 mL/min, as limited changes in creatinine clearance during study conduct will lead to protocol-mandated product holds and may alter the risk-benefit considerations of study participation\n * Alanine aminotransferase (ALT) less than 2 times the upper limit of normal (ULN)\n * Total bilirubin less than or equal to 2.5 times ULN\n * Hepatitis B virus (HBV) surface antigen (HBsAg) negative\n * Hepatitis C virus (HCV) Ab negative\n * No Grade 3 or higher laboratory abnormalities on any laboratory tests obtained at screening, including tests obtained as part of a panel of tests ordered to obtain the protocol-required laboratory test results.\n* No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records)\n* Willing to undergo all required study procedures\n\nExclusion Criteria:\n\n* One or more reactive or positive HIV test result at Screening or Enrollment, even if HIV infection is not confirmed\n* Active or recent use of any illicit intravenous drugs ("recent" defined as in the 90 days prior to enrollment)\n* Co-enrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation. Exceptions may be made if appropriate after consultation with the CMC.)\n* Past or current participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm). Note: Past participation in a monoclonal antibody study is not exclusionary, effective as of Version 1.0 of HPTN 083.\n* Clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease\n* Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, per the discretion of the Investigator of Record. Mild skin conditions may not be exclusionary at the discretion of the Investigator of Record (IoR) or designee in consultation with the CMC\n* Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the IoR or designee, in consultation with the CMC, may interfere with interpretation of injection site reactions\n* Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert\'s syndrome, asymptomatic gallstones, or cholecystectomy)\n* Coagulopathy (primary or iatrogenic) which would contraindicate IM injection (concomitant anticoagulant or anti-platelet therapy use should be discussed with the CMC)\n* Active or planned use of prohibited medications as described in the Investigator\'s Brochure or listed in the Study Specific Procedures (SSP) Manual (provided by self-report, or obtained from medical history or medical records). In particular, future use of TDF/FTC at any point during the study.\n* Known or suspected allergy to study product components (active or placebo), including egg or soy products (egg and soy products are contained in Intralipid)\n* Surgically-placed or injected buttock implants or fillers, per self-report. Contact the CMC for guidance regarding questions about individual cases.\n* Alcohol or substance use that, in the opinion of the study investigator, would jeopardize the safety of the participant on study (e.g., provided by self-report, or found upon medical history and examination or in available medical records).\n* History of seizure disorder, per self-report\n* QTc interval (B or F) greater than 500 msec'}, 'identificationModule': {'nctId': 'NCT02720094', 'briefTitle': 'Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men', 'orgStudyIdInfo': {'id': 'HPTN 083'}, 'secondaryIdInfos': [{'id': '20725', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.', 'interventionNames': ['Drug: Cabotegravir Oral Tablet', 'Drug: TDF/FTC tablets', 'Drug: Placebo for TDF/FTC tablets', 'Drug: CAB LA']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.', 'interventionNames': ['Drug: TDF/FTC tablets', 'Drug: Placebo for cabotegravir oral tablet', 'Drug: Placebo for CAB LA']}], 'interventions': [{'name': 'Cabotegravir Oral Tablet', 'type': 'DRUG', 'otherNames': ['Oral cabotegravir'], 'description': '30 mg tablet', 'armGroupLabels': ['Arm A']}, {'name': 'TDF/FTC tablets', 'type': 'DRUG', 'otherNames': ['Truvada'], 'description': '300 mg/200 mg fixed-dose combination tablets', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Placebo for TDF/FTC tablets', 'type': 'DRUG', 'otherNames': ['Placebo for Truvada'], 'armGroupLabels': ['Arm A']}, {'name': 'Placebo for cabotegravir oral tablet', 'type': 'DRUG', 'otherNames': ['Placebo for oral cabotegravir'], 'armGroupLabels': ['Arm B']}, {'name': 'CAB LA', 'type': 'DRUG', 'otherNames': ['Long acting cabotegravir', 'Injectable cabotegravir'], 'description': 'Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter', 'armGroupLabels': ['Arm A']}, {'name': 'Placebo for CAB LA', 'type': 'DRUG', 'otherNames': ['Placebo for long acting cabotegravir'], 'description': 'Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Vine Street Clinic CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Center (EBAC) CRS', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Bridge HIV CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado CRS", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20037-1894', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington Univ. 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'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}, {'zip': '11000', 'city': 'Bangkok', 'state': 'Changwat Nonthaburi', 'country': 'Thailand', 'facility': 'Silom Community Clinic CRS'}, {'zip': '50202', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'CMU HIV Prevention CRS', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '100000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Yen Hoa Health Clinic CRS', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Raphael J. 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