Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-31 @ 9:42 PM
Study NCT ID:
NCT04311502
Status:
TERMINATED
Last Update Posted:
2025-08-27
First Post:
2020-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico', 'Thailand'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018421', 'term': 'rifapentine'}, {'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D007538', 'term': 'Isoniazid'}, {'id': 'D011718', 'term': 'Pyrazinamide'}, {'id': 'D004977', 'term': 'Ethambutol'}, {'id': 'D002991', 'term': 'Clofazimine'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010619', 'term': 'Phenazines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.gov@fstrf.org', 'phone': '(301) 628-3348', 'title': 'ACTG Clinicaltrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Enrollment to this study was terminated early based on a recommendation from the independent DSMB for the study. This was due to the high rate of unfavorable outcomes and recurrences in Arm 1. As a consequence, the study had reduced precision to evaluate the primary biomarker outcome related to time to stable culture conversion.'}}, 'adverseEventsModule': {'timeFrame': 'From entry through Week 65', 'description': 'Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017. An adverse event is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution.\n\nAdverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm1', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nDoses (administered orally once daily): rifapentine, 1200mg; isoniazid, 300mg; pyrazinamide, 40 to \\<55kg 1000mg, 55to \\<71kg 1500mg; ≥71kg 2000mg; ethambutol, 40 to \\<55kg 800mg, 55to \\<71kg 1200mg; ≥71 kg 1600mg\n\nRifapentine: 1200 mg once daily\n\nIsoniazid: 300 mg once daily\n\nPyrazinamide: 1000mg once daily if weight is 40 to \\<55kg 1500mg once daily if weight is 55to \\<71kg 2000mg once if weight is ≥71kg\n\nEthambutol: 800 mg once daily if weight is 40 to \\<55kg 1200 mg once daily if weight is 55 to \\<71kg 1600mg once if weight is ≥71kg\n\nClofazimine: 300 mg once daily for 2 weeks (loading dose). 100 mg once daily', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 25, 'seriousNumAtRisk': 58, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Arm2', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nDoses (administered orally once daily): rifampicin, 600mg; isoniazid, 300mg; pyrazinamide, 40 to \\<55kg 1000mg, 55to \\<71kg 1500mg; ≥71 kg 2000mg; ethambutol, 40 to \\<55kg 800mg, 55to \\<71kg 1200mg; ≥71 kg 1600mg\n\nRifampicin: 600 mg once daily\n\nIsoniazid: 300 mg once daily\n\nPyrazinamide: 1000mg once daily if weight is 40 to \\<55kg 1500mg once daily if weight is 55to \\<71kg 2000mg once if weight is ≥71kg\n\nEthambutol: 800 mg once daily if weight is 40 to \\<55kg 1200 mg once daily if weight is 55 to \\<71kg 1600mg once if weight is ≥71kg', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 7, 'seriousNumAtRisk': 31, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'ArmC', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nDoses (for on study medications; administered orally once daily): rifapentine, 1200mg; isoniazid, 300mg; pyrazinamide, 40 to \\<55kg 1000mg, 55to \\<71kg 1500mg; ≥71 kg 2000mg; ethambutol, 40 to \\<55kg 800mg, 55to \\<71kg 1200mg; ≥71 kg 1600mg\n\nRifapentine: 1200 mg once daily\n\nIsoniazid: 300 mg once daily\n\nPyrazinamide: 1000mg once daily if weight is 40 to \\<55kg 1500mg once daily if weight is 55to \\<71kg 2000mg once if weight is ≥71kg\n\nEthambutol: 800 mg once daily if weight is 40 to \\<55kg 1200 mg once daily if weight is 55 to \\<71kg 1600mg once if weight is ≥71kg\n\nClofazimine: 300 mg once daily for 2 weeks (loading dose). 100 mg once daily', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Scabies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Glycosuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}], 'seriousEvents': [{'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Cerebral toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Immune reconstitution inflammatory syndrome associated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 28.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to 12 Weeks Stable Culture Conversion in Liquid Media', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.21', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.79', 'estimateComment': 'Arm 1 vs Arm 2', 'groupDescription': 'This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Entry through Week 12', 'description': 'The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB.\n\nIf a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion they were censored at 12 weeks. Participants who were lost to follow-up prior to 12 weeks with their last culture being positive were censored at 12 weeks (i.e. assumed they did not have a culture conversion by week 12), and participants who were lost to follow-up prior to 12 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'PRIMARY', 'title': 'Participants Experiencing Any Grade 3 or Higher Adverse Event (AE) That is at Least a One Grade Increase From Baseline Over 65 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}, {'id': 'OG002', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}], 'classes': [{'title': 'Number of Participants through Primary Manuscript Cutoff date of September 25, 2023', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Number of Participants through Week 65', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.30', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.45', 'estimateComment': 'Difference in cumulative proportions (Arm 1 - Arm 2)', 'groupDescription': 'The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.\n\nThis outcome measure is limited to data obtained up to September 25, 2023.', 'statisticalMethod': 'Wald chi-square test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.28', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.44', 'estimateComment': 'Difference in cumulative proportions (Arm 1 - Arm 2)', 'groupDescription': 'The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.\n\nAll data through week 65.', 'statisticalMethod': 'Wald chi-square test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From entry through Week 65', 'description': 'An adverse event is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution.\n\nAdverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1, Corrected Version 2.1, July 2017)\n\nThe primary manuscript outcome measure includes data through week 65 up to September 25, 2023', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: All participants who started assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Favorable Clinical/Bacteriologic Outcome (Definition A) at 65 Weeks Post-randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '.50', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.62'}, {'value': '.76', 'groupId': 'OG001', 'lowerLimit': '.56', 'upperLimit': '.88'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '-0.06', 'estimateComment': 'Difference in cumulative proportions (Arm 1 - Arm 2)', 'groupDescription': 'The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.', 'statisticalMethod': 'Wald chi-square test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From entry through Week 65', 'description': 'Favorable Outcome are:\n\n* liquid culture negative at week 65\n* without signs or symptoms of ongoing active TB and unable to produce sputum at 65 weeks\n* who at the end of the follow-up period are clinically without signs/symptoms of ongoing active TB and produce a sputum specimen that is contaminated in two liquid cultures without evidence of TB\n\nUnfavorable:\n\n* Absence of cure: Having a sputum sample at or after EOT that is culture-positive (any medium) with a second positive sample obtained 4 hours following the first sample.\n* Death from any cause except for violent or accidental cause\n* Had a positive culture for Mtb when last seen\n* Had a treatment extension beyond nominal level due to clinically inadequate response\n\nUnevaluable are:\n\n* lost to follow-up during treatment or post-treatment with their last culture being negative for Mtb\n* violent or accidental death\n* becoming pregnant during their assigned active treatment and stop their assigned treatment.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Favorable Composite Outcome (Definition B) at 65 Weeks Post-randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.61'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '0.86'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '-0.04', 'estimateComment': 'Difference in cumulative proportions (Arm 1 - Arm 2)', 'groupDescription': 'The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.', 'statisticalMethod': 'Wald chi-square', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From entry through Week 65', 'description': 'Favorable Outcome are:\n\nSame as definition A\n\nUnfavorable:\n\nSame as definition A and:\n\n* lost to follow-up during treatment phase\n* failing to complete treatment\n* receiving any one or more of the following: extension of treatment beyond the nominal level, except to make up missed doses; re-starting treatment following \\>= 30 consecutive days lost to follow-up; a change in at least one drug in treatment regimen for any reason except re-infection, pregnancy, or temporary drug challenge\n\nUnevaluable are:\n\n* lost to follow-up after treatment phase, and not assessable at the end of follow-up, with their last culture being negative for Mtb\n* Violent death or accidental death\n* Women who become pregnant during their assigned active treatment and stop their assigned treatment', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Prematurely Discontinue Their Treatment Regimen Through 65 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.05', 'estimateComment': 'Difference in proportions (Arm 1 - Arm 2); exact confidence interval', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': "Fisher's exact test was used to test for a difference in proportions"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From entry through Week 65', 'description': 'Premature discontinuation is defined as discontinuation other than due to violent death, natural disaster, or administrative censoring', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: All participants who started assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Mean QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Mean QTcF Interval at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '419', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '401', 'spread': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'Mean QTcF Interval at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '422', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '408', 'spread': '16.8', 'groupId': 'OG001'}]}]}, {'title': 'Mean QTcF Interval at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '427', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '407', 'spread': '20.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Weeks 2, 8, and 13 (end of investigational treatment)', 'description': 'QT interval measured as the average of three electrocardiogram (ECG) readings taken 5-10 minutes apart, corrected with Fridericia correction', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Limited to available data'}, {'type': 'SECONDARY', 'title': 'QTcF Interval Mean Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Change in mean QTcF from Week 2 to Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.9', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '0.736', 'spread': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Change in mean QTcF from Week 8 to Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Change in mean QTcF from Week 13 to Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '19.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GEE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.04', 'ciLowerLimit': '15.13', 'ciUpperLimit': '32.94', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and Weeks 2, 8, and 13 (end of investigational treatment)', 'description': 'Mean change from baseline in mean QTcF at weeks 2, 8, and end of treatment (EOT)', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Limited to participants with available data'}, {'type': 'SECONDARY', 'title': 'Categorized QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Absolute QTcF ≥480 ms and <500 ms', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Absolute QTcF ≥500 ms', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Absolute QTcF < 480 ms', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Absolute QTcF ≥480 ms and <500 ms', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Absolute QTcF ≥500 ms', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Absolute QTcF < 480 ms', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Absolute QTcF ≥480 ms and <500 ms', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Absolute QTcF ≥500 ms', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Absolute QTcF < 480 ms', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2, 8, and Week 13', 'description': 'Absolute QTcF was categorized as:\\< 480; ≥480 ms and \\<500 ms; ≥500 ms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: participants who started Arm 1 and Arm 2 and with data available.'}, {'type': 'SECONDARY', 'title': 'Categorized Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'title': 'QTcF change from baseline of ≥30 ms and <60 ms', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'QTcF change from baseline of ≥60 ms', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'QTcF change from baseline of <30 ms', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'title': 'QTcF change from baseline of ≥30 ms and <60 ms', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'QTcF change from baseline of ≥60 ms', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'QTcF change from baseline of <30 ms', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'title': 'QTcF change from baseline of ≥30 ms and <60 ms', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'QTcF change from baseline of ≥60 ms', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'QTcF change from baseline of <30 ms', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.15', 'ciLowerLimit': '2.40', 'ciUpperLimit': '21.30', 'groupDescription': 'Compares the odds of participants having maximum occurrence of QTcF change from baseline of ≥30 ms and \\<60 ms, or ≥60 ms between Arm 1 and Arm 2 in the safety set using the proportional odds model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.58', 'estimateComment': 'Arm 1 - Arm 2', 'groupDescription': 'Proportion of Participants with Worst Changes in QTcF from Screening \\>= 30 ms over visits at Weeks 2, 8, 13', 'statisticalMethod': 'exact unconditional', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at Weeks 2, 8, and Week 13', 'description': 'Categorized change from baseline as: change from baseline of \\<30 ms; change from baseline of ≥30 ms and \\<60 ms; change from baseline of ≥60 ms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Limited to the safety analysis set, participants who started assigned treatment, in Arm 1 and Arm 2 and with available data.'}, {'type': 'SECONDARY', 'title': 'Time to Stable Culture Conversion in Liquid Media Through Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.23', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.80', 'pValueComment': 'One-sided p-value', 'estimateComment': 'Arm 1 vs. Arm 2', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for HIV status (positive/negative) and TB disease according to chest X-ray (advanced/not advanced)'}], 'paramType': 'MEDIAN', 'timeFrame': 'From entry through Week 65', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'SECONDARY', 'title': 'Time to Stable Culture Conversion in Solid Media Through Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.17', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.71', 'pValueComment': 'One-sided p-value', 'groupDescription': 'This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From entry through Week 65', 'description': 'The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB.\n\nIf a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion, the death was considered as a competing event. Participants who were lost to follow-up prior to 65 weeks with their last culture being positive were censored at 65 weeks (i.e. assumed they did not have a culture conversion by week 65), and participants who were lost to follow-up prior to 65 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result.\n\nAdjusted model adjusts for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Stable Liquid Culture Conversion by Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.35', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From entry through Week 8', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Stable Solid Culture Conversion by Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.24', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From entry through Week 8', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}, {'id': 'OG002', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.07', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.18', 'estimateComment': 'Difference in cumulative proportions (Arm 1 - Arm 2)', 'groupDescription': 'The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing an SAE through week 65 was compared between Arm 1 and Arm 2.', 'statisticalMethod': 'Wald chi-square test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From entry through Week 65', 'description': 'Cumulative proportion with at least one Serious Adverse Event (SAE)\n\nA SAE is defined as any untoward medical occurrence that:\n\n* Results in death\n* Is life-threatening\n* Requires inpatient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Is an important medical event that many not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set: All participants who started assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Stable Solid Culture Conversion by Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.13', 'estimateComment': 'Difference in proportions (Arm 1 - Arm 2); exact confidence interval', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': "Fisher's exact test was used to test for a difference in proportions"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From entry through Week 12', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions.'}, {'type': 'SECONDARY', 'title': 'Median Time (Days) to Positivity in Liquid Culture (MGIT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Screening Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.17', 'groupId': 'OG000', 'lowerLimit': '3.83', 'upperLimit': '7.67'}, {'value': '5.67', 'groupId': 'OG001', 'lowerLimit': '4.04', 'upperLimit': '8.08'}]}]}, {'title': 'Entry Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.63', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '11.2'}, {'value': '8.23', 'groupId': 'OG001', 'lowerLimit': '7.21', 'upperLimit': '10.3'}]}]}, {'title': 'Week 1 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '7.33', 'upperLimit': '18.3'}]}]}, {'title': 'Week 2 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '22.4'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '9.96', 'upperLimit': '18.9'}]}]}, {'title': 'Week 3 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '8.29', 'upperLimit': '42'}]}]}, {'title': 'Week 4 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '42'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '38'}]}]}, {'title': 'Week 6 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '42'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '42'}]}]}, {'title': 'Week 8 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '42'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '42'}]}]}, {'title': 'Week 10 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '42'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '42'}]}]}, {'title': 'Week 12 Time to Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '42'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '42'}]}]}], 'analyses': [{'pValue': '0.597', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.39', 'groupDescription': 'Time point: Screening', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.44', 'groupDescription': 'Time point: Entry', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.03', 'groupDescription': 'Time point: Week 2', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.98', 'groupDescription': 'Time point: Week 4', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.67', 'groupDescription': 'Time point: Week 6', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.88', 'groupDescription': 'Time point: Week 8', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.25', 'ciUpperLimit': '2.44', 'groupDescription': 'Time point: Week 10', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.21', 'ciUpperLimit': '6.39', 'groupDescription': 'Time point: Week 12', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From screening, entry, weeks 1, 2, 3, 4, 6, 8, 10, 12', 'description': 'Time (days) to positivity in liquid culture (MGIT) is defined as the number of days it takes for the culture to produce results up to a max of 42 days. For negative culture results, time to positivity is imputed as 42 days.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions with data available.'}, {'type': 'SECONDARY', 'title': 'Change in Chest X-ray Score From Baseline to End of Treatment in Each Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.51', 'groupId': 'OG000', 'lowerLimit': '-34.27', 'upperLimit': '-16.75'}, {'value': '-46.10', 'groupId': 'OG001', 'lowerLimit': '-58.04', 'upperLimit': '-34.16'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.43', 'ciLowerLimit': '5.71', 'ciUpperLimit': '35.16', 'groupDescription': 'This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Entry, End of Treatment (Week 13 for Arm 1 and Week 26 for Arm 2)', 'description': 'The chest X-ray was posterior-anterior. Extent of disease (limited to one lobe or region, unilateral, bilateral, or diffuse) and cavitation status (cavities present \\[location\\] or absent) was documented by validated numerical score (percent of total lung affected by any pathology + 40 if cavitation is present; 0 = No percent affected, 140 = entire lung is affected + cavitation is present) for grading chest X-ray in adult smear-positive pulmonary TB (Thorax 2010; 65(10):863-9).\n\nAnalysis was conducted based on site readings of CXR', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions and had data available at both time points.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Have a TB Relapse, From End of Treatment Until Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'timeFrame': 'From end of treatment (week 13 for Arm 1; week 26 for Arm 2) to week 65', 'description': 'The time of relapse is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media for an Mtb strain that has matching genotype with the baseline isolate (as determined by whole genome sequencing). A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a relapse. If the second sputum sample was negative, this was not counted as a relapse. If a participant was lost to follow-up without a second sputum sample confirmation of relapse (including contaminated or missing), it was counted as a relapse.\n\nWhole genome sequencing of samples, which is necessary to assess TB relapse, was not performed due to lack of funding. There is no plan to test these samples in the future.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants have results as results for whole genome sequencing, which is necessary to assess TB relapse, was not performed due to lack of funding. There is no plan to test these samples in the future.'}, {'type': 'SECONDARY', 'title': 'Cumulative Proportion of Participants Who Have a TB Recurrence, From End of Treatment Until Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Within 26 Weeks of Treatment Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.35'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.24'}]}]}, {'title': 'Within 39 Weeks of Treatment Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.37'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.24'}]}]}, {'title': 'Within 52Weeks of Treatment Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '0.37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From end of treatment (week 13 for Arm 1; week 26 for Arm 2) to week 65', 'description': 'The time of recurrence is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media. A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a recurrence. If the second sputum sample was negative, this will not be counted as a recurrence. If a participant was lost to follow-up without a second sputum sample confirmation of recurrence (including contaminated or missing), it was counted as a recurrence.\n\nParticipants at risk for recurrence where those who were stable culture conversions by end of treatment.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy set: All participants who were randomized to study treatment Arm 1 or Arm 2 and were not late exclusions and at risk for TB Recurrence'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameter for CFZ: Minimum Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.473', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '0.169', 'spread': '0.088', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.594', 'spread': '0.197', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intensive PK tests were performed at weeks 2 and 13 on Arm 1 participants who consent and were registered to the Intensive PK subgroup and at week 2 on Arm C participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameter for CFZ: Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.861', 'spread': '0.286', 'groupId': 'OG000'}, {'value': '0.277', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.819', 'spread': '0.247', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intensive PK tests were performed at weeks 2 and 13 on Arm 1 participants who consent and were registered to the Intensive PK subgroup and at week 2 on Arm C participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameter for CFZ: Time of Cmax (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.97', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '7.74', 'spread': '4.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.27', 'spread': '4.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intensive PK tests were performed at weeks 2 and 13 on Arm 1 participants who consent and were registered to the Intensive PK subgroup and at week 2 on Arm C participants.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameter for CFZ: Area Under the Concentration Curve (AUC0-24h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '5.58', 'groupId': 'OG000'}, {'value': '5.42', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '5.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.', 'unitOfMeasure': 'mg/L*h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intensive PK tests were performed at weeks 2 and 13 on Arm 1 participants who consent and were registered to the Intensive PK subgroup and at week 2 on Arm C participants.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Skin Pigmentation (Colorimetric L*)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Inner Arm - Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.54', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.72', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '3', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '3.52', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.61', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.65', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '2.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). L represents lightness (0 = black, 100 = white).\n\nFurther data processing removed values if one of the triplicates differed more than 5% of the median.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Limited to the safety analysis set, participants who started assigned treatment, and were not premature study discontinuations before week 8 and had data available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Skin Pigmentation (Colorimetric a*)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Inner Arm - Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '.20', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '6.40', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '4.97', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.96', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '5.96', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.58', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '3.77', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '2.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The a\\* parameter represents the balance between red and green. Positive values of a\\* indicate a reddish tone, while negative values indicate a greenish tone. (-128 = Green, 127 = Red).\n\nFurther data processing removed values if one of the triplicates differed more than 5% of the median.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Limited to the safety analysis set, participants who started assigned treatment, and were not premature study discontinuations before week 8 and had data available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Skin Pigmentation (Colorimetric b*)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Inner Arm - Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '3.07', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.27', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '4.28', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.52', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '3.86', 'groupId': 'OG001'}]}]}, {'title': 'Inner Arm - Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.70', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '4.06', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.48', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.65', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Face - Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.72', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The b\\* parameter represents the balance between yellow and blue. Positive values of b\\* indicate a yellowish tone, while negative values indicate a bluish tone (-128 = Blue, 127 = Yellow).\n\nFurther data processing removed values if one of the triplicates differed more than 5% of the median.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Limited to the safety analysis set, participants who started assigned treatment, and were not premature study discontinuations before week 8 and had data available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant-reported Changes in Skin Pigment Related to Perceived Skin Hyperpigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.60', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'Subjective questionnaire asked the following questions :\n\n1.) On a scale from 0 to 10: (0 being none and 10 being most significant possible) How would you rate any change in the coloration of your skin since you began TB treatment?', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Arm 1 and Arm 2 with follow-up after week 8'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Participant-reported Distress Caused by Change in Skin Pigment Related to Perceived Skin Hyperpigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'OG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'Subjective questionnaire asked the following questions:\n\nOn a scale from 0 to 10: (0 being none and 10 being worst possible) How would you rate your distress to skin coloration changes since you began TB treatment, if any?', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Arm 1 and Arm 2 with follow-up after week 8'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'FG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}, {'id': 'FG002', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Started Treatment and Were Not Late Exclusions', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant is in prison', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant moved out of country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'DSMB Mandated Extension of follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled from November 2021 to March 2023 in 6 sites located in Malawi (2 sites), South Africa, Zimbabwe, India, and Haiti. A screening and accrual pause was instated on April 4, 2023 and subsequently formally closed to accrual on June 2, 2023 in response to recommendations from the DSMB.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine loading dose: (CFZ) 300 mg once daily for 2 weeks (loading dose), then 100 mg once daily'}, {'id': 'BG001', 'title': 'Arm 2: Standard of Care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.\n\nRifampicin: (R) 600 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg'}, {'id': 'BG002', 'title': 'Arm C: PK Only Subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).\n\nRifapentine: (P) 1200 mg once daily Isoniazid: (H) 300 mg once daily Pyrazinamide: (Z) 1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55to \\<71kg; 2000mg once if weight is ≥71kg Ethambutol: (E) 800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg Clofazimine: (CFZ) 100 mg once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '39'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '38'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '43'}, {'value': '33', 'groupId': 'BG003', 'lowerLimit': '27', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'ASIAN', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'BLACK OR AFRICAN AMERICAN', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Haiti', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Malawi', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Zimbabwe', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-08', 'size': 1461975, 'label': 'Study Protocol and Informed Consent Form: Protocol Version 2.0', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2025-02-10T12:03', 'hasProtocol': True}, {'date': '2022-12-12', 'size': 174106, 'label': 'Study Protocol: Clarification Memo 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-10T12:05', 'hasProtocol': True}, {'date': '2023-06-22', 'size': 265849, 'label': 'Study Protocol: Letter of Amendment 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-10T12:06', 'hasProtocol': True}, {'date': '2023-10-13', 'size': 611998, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-04T14:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'whyStopped': 'Accrual was permanently closed due to futility in the experimental arm on June 22, 2023. Follow-up in the experimental arm was extended to 117 weeks.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2020-03-05', 'resultsFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-08', 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to 12 Weeks Stable Culture Conversion in Liquid Media', 'timeFrame': 'From Entry through Week 12', 'description': 'The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB.\n\nIf a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion they were censored at 12 weeks. Participants who were lost to follow-up prior to 12 weeks with their last culture being positive were censored at 12 weeks (i.e. assumed they did not have a culture conversion by week 12), and participants who were lost to follow-up prior to 12 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result.'}, {'measure': 'Participants Experiencing Any Grade 3 or Higher Adverse Event (AE) That is at Least a One Grade Increase From Baseline Over 65 Weeks', 'timeFrame': 'From entry through Week 65', 'description': 'An adverse event is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution.\n\nAdverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1, Corrected Version 2.1, July 2017)\n\nThe primary manuscript outcome measure includes data through week 65 up to September 25, 2023'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Favorable Clinical/Bacteriologic Outcome (Definition A) at 65 Weeks Post-randomization', 'timeFrame': 'From entry through Week 65', 'description': 'Favorable Outcome are:\n\n* liquid culture negative at week 65\n* without signs or symptoms of ongoing active TB and unable to produce sputum at 65 weeks\n* who at the end of the follow-up period are clinically without signs/symptoms of ongoing active TB and produce a sputum specimen that is contaminated in two liquid cultures without evidence of TB\n\nUnfavorable:\n\n* Absence of cure: Having a sputum sample at or after EOT that is culture-positive (any medium) with a second positive sample obtained 4 hours following the first sample.\n* Death from any cause except for violent or accidental cause\n* Had a positive culture for Mtb when last seen\n* Had a treatment extension beyond nominal level due to clinically inadequate response\n\nUnevaluable are:\n\n* lost to follow-up during treatment or post-treatment with their last culture being negative for Mtb\n* violent or accidental death\n* becoming pregnant during their assigned active treatment and stop their assigned treatment.'}, {'measure': 'Proportion of Participants With Favorable Composite Outcome (Definition B) at 65 Weeks Post-randomization', 'timeFrame': 'From entry through Week 65', 'description': 'Favorable Outcome are:\n\nSame as definition A\n\nUnfavorable:\n\nSame as definition A and:\n\n* lost to follow-up during treatment phase\n* failing to complete treatment\n* receiving any one or more of the following: extension of treatment beyond the nominal level, except to make up missed doses; re-starting treatment following \\>= 30 consecutive days lost to follow-up; a change in at least one drug in treatment regimen for any reason except re-infection, pregnancy, or temporary drug challenge\n\nUnevaluable are:\n\n* lost to follow-up after treatment phase, and not assessable at the end of follow-up, with their last culture being negative for Mtb\n* Violent death or accidental death\n* Women who become pregnant during their assigned active treatment and stop their assigned treatment'}, {'measure': 'Number of Participants Who Prematurely Discontinue Their Treatment Regimen Through 65 Weeks', 'timeFrame': 'From entry through Week 65', 'description': 'Premature discontinuation is defined as discontinuation other than due to violent death, natural disaster, or administrative censoring'}, {'measure': 'Mean QTcF', 'timeFrame': 'Measured at Weeks 2, 8, and 13 (end of investigational treatment)', 'description': 'QT interval measured as the average of three electrocardiogram (ECG) readings taken 5-10 minutes apart, corrected with Fridericia correction'}, {'measure': 'QTcF Interval Mean Change From Baseline', 'timeFrame': 'Measured at baseline and Weeks 2, 8, and 13 (end of investigational treatment)', 'description': 'Mean change from baseline in mean QTcF at weeks 2, 8, and end of treatment (EOT)'}, {'measure': 'Categorized QTcF', 'timeFrame': 'Week 2, 8, and Week 13', 'description': 'Absolute QTcF was categorized as:\\< 480; ≥480 ms and \\<500 ms; ≥500 ms'}, {'measure': 'Categorized Change From Baseline', 'timeFrame': 'Measured at Weeks 2, 8, and Week 13', 'description': 'Categorized change from baseline as: change from baseline of \\<30 ms; change from baseline of ≥30 ms and \\<60 ms; change from baseline of ≥60 ms'}, {'measure': 'Time to Stable Culture Conversion in Liquid Media Through Week 65', 'timeFrame': 'From entry through Week 65', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB'}, {'measure': 'Time to Stable Culture Conversion in Solid Media Through Week 65', 'timeFrame': 'From entry through Week 65', 'description': 'The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB.\n\nIf a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion, the death was considered as a competing event. Participants who were lost to follow-up prior to 65 weeks with their last culture being positive were censored at 65 weeks (i.e. assumed they did not have a culture conversion by week 65), and participants who were lost to follow-up prior to 65 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result.\n\nAdjusted model adjusts for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).'}, {'measure': 'Number of Participants Achieving Stable Liquid Culture Conversion by Week 8', 'timeFrame': 'From entry through Week 8', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB'}, {'measure': 'Number of Participants Achieving Stable Solid Culture Conversion by Week 8', 'timeFrame': 'From entry through Week 8', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB'}, {'measure': 'Number of Participants With One or More Serious Adverse Events (SAEs)', 'timeFrame': 'From entry through Week 65', 'description': 'Cumulative proportion with at least one Serious Adverse Event (SAE)\n\nA SAE is defined as any untoward medical occurrence that:\n\n* Results in death\n* Is life-threatening\n* Requires inpatient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Is an important medical event that many not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above.'}, {'measure': 'Number of Participants Achieving Stable Solid Culture Conversion by Week 12', 'timeFrame': 'From entry through Week 12', 'description': 'Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB'}, {'measure': 'Median Time (Days) to Positivity in Liquid Culture (MGIT)', 'timeFrame': 'From screening, entry, weeks 1, 2, 3, 4, 6, 8, 10, 12', 'description': 'Time (days) to positivity in liquid culture (MGIT) is defined as the number of days it takes for the culture to produce results up to a max of 42 days. For negative culture results, time to positivity is imputed as 42 days.'}, {'measure': 'Change in Chest X-ray Score From Baseline to End of Treatment in Each Arm', 'timeFrame': 'Entry, End of Treatment (Week 13 for Arm 1 and Week 26 for Arm 2)', 'description': 'The chest X-ray was posterior-anterior. Extent of disease (limited to one lobe or region, unilateral, bilateral, or diffuse) and cavitation status (cavities present \\[location\\] or absent) was documented by validated numerical score (percent of total lung affected by any pathology + 40 if cavitation is present; 0 = No percent affected, 140 = entire lung is affected + cavitation is present) for grading chest X-ray in adult smear-positive pulmonary TB (Thorax 2010; 65(10):863-9).\n\nAnalysis was conducted based on site readings of CXR'}, {'measure': 'Proportion of Participants Who Have a TB Relapse, From End of Treatment Until Week 65', 'timeFrame': 'From end of treatment (week 13 for Arm 1; week 26 for Arm 2) to week 65', 'description': 'The time of relapse is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media for an Mtb strain that has matching genotype with the baseline isolate (as determined by whole genome sequencing). A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a relapse. If the second sputum sample was negative, this was not counted as a relapse. If a participant was lost to follow-up without a second sputum sample confirmation of relapse (including contaminated or missing), it was counted as a relapse.\n\nWhole genome sequencing of samples, which is necessary to assess TB relapse, was not performed due to lack of funding. There is no plan to test these samples in the future.'}, {'measure': 'Cumulative Proportion of Participants Who Have a TB Recurrence, From End of Treatment Until Week 65', 'timeFrame': 'From end of treatment (week 13 for Arm 1; week 26 for Arm 2) to week 65', 'description': 'The time of recurrence is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media. A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a recurrence. If the second sputum sample was negative, this will not be counted as a recurrence. If a participant was lost to follow-up without a second sputum sample confirmation of recurrence (including contaminated or missing), it was counted as a recurrence.\n\nParticipants at risk for recurrence where those who were stable culture conversions by end of treatment.'}, {'measure': 'Pharmacokinetic Parameter for CFZ: Minimum Concentration (Cmin)', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.'}, {'measure': 'Pharmacokinetic Parameter for CFZ: Maximum Concentration (Cmax)', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.'}, {'measure': 'Pharmacokinetic Parameter for CFZ: Time of Cmax (Tmax)', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.'}, {'measure': 'Pharmacokinetic Parameter for CFZ: Area Under the Concentration Curve (AUC0-24h)', 'timeFrame': 'Measured at Weeks 2 and 13', 'description': 'Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.'}, {'measure': 'Mean Change From Baseline in Skin Pigmentation (Colorimetric L*)', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). L represents lightness (0 = black, 100 = white).\n\nFurther data processing removed values if one of the triplicates differed more than 5% of the median.'}, {'measure': 'Mean Change From Baseline in Skin Pigmentation (Colorimetric a*)', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The a\\* parameter represents the balance between red and green. Positive values of a\\* indicate a reddish tone, while negative values indicate a greenish tone. (-128 = Green, 127 = Red).\n\nFurther data processing removed values if one of the triplicates differed more than 5% of the median.'}, {'measure': 'Mean Change From Baseline in Skin Pigmentation (Colorimetric b*)', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The b\\* parameter represents the balance between yellow and blue. Positive values of b\\* indicate a yellowish tone, while negative values indicate a bluish tone (-128 = Blue, 127 = Yellow).\n\nFurther data processing removed values if one of the triplicates differed more than 5% of the median.'}, {'measure': 'Change From Baseline in Participant-reported Changes in Skin Pigment Related to Perceived Skin Hyperpigmentation', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'Subjective questionnaire asked the following questions :\n\n1.) On a scale from 0 to 10: (0 being none and 10 being most significant possible) How would you rate any change in the coloration of your skin since you began TB treatment?'}, {'measure': 'Change From Baseline in Participant-reported Distress Caused by Change in Skin Pigment Related to Perceived Skin Hyperpigmentation', 'timeFrame': 'Entry, Weeks 8, 13, 26, and 65', 'description': 'Subjective questionnaire asked the following questions:\n\nOn a scale from 0 to 10: (0 being none and 10 being worst possible) How would you rate your distress to skin coloration changes since you began TB treatment, if any?'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rifapentine', 'clofazimine', 'drug-susceptible tuberculosis', 'tuberculosis treatment shortening'], 'conditions': ['HIV', 'Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '40915311', 'type': 'DERIVED', 'citation': 'Metcalfe JZ, Weir IR, Scarsi KK, Mendoza-Ticona A, Pierre S, Hall L, Leon-Cruz J, Svensson EM, Koele SE, Samaneka W, Kanyama C, Yohane M, Nevrekar N, Ntsalaze B, Marc JB, Goth M, Maartens G, Chaisson R; ACTG A5362 study team. A 3-month clofazimine-rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial. Lancet Infect Dis. 2025 Sep 4:S1473-3099(25)00436-0. doi: 10.1016/S1473-3099(25)00436-0. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf', 'label': 'DAIDS AE Grading Table'}, {'url': 'https://rsc.niaid.nih.gov/sites/default/files/manual-exped-aes-v2_0.pdf', 'label': 'Manual for Expedited Reporting of Adverse Events to DAIDS'}, {'url': 'https://thorax.bmj.com/content/65/10/863.long', 'label': 'A simple, valid, numerical score for grading chest x-ray severity in adult smear-positive pulmonary tuberculosis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) regimen for drug-susceptible (DS) tuberculosis (TB).', 'detailedDescription': "This study compared a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) for drug-susceptible (DS) tuberculosis (TB).\n\nRandomization was stratified based on HIV status and the presence of advanced disease as determined by chest X-ray.\n\nParticipants were randomized to one of three arms:\n\n* Arm 1 (Experimental): rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + CFZ 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks\n* Arm 2 (SOC): rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks\n* Arm C (PK-only subgroup): PHZE + CFZ 100 mg once daily for 4 weeks; then remain on study, off study medications and treated according to SOC (RHZE for 4 weeks; then RH for 18 weeks)\n\nAll participants received pyridoxine (vitamin B6) with each dose of isoniazid (INH) based on current local, national or international dosing guidelines.\n\nArm 1 participants were treated for 13 weeks (including a 2-week CFZ loading dose of 300 mg daily). Arm 2 participants were treated for 26 weeks, and Arm C participants were treated for 4 weeks.\n\nAll participants in Arms 1, 2, and C were followed from randomization to Week 65.\n\nOn June 1, 2023, the Data and Safety Monitoring Board (DSMB) recommended that the study permanently close to accrual because of the high rate of treatment failure and TB recurrence. The A5362 team, NIAID and DAIDS leadership, and ACTG leadership concurred with the DSMB's recommendation and the study was closed to accrual on June 2, 2023. A letter of amendment was created that extended follow-up to 117 weeks for some participants in Arm 1.\n\nDue to the early close to accrual, a primary analysis report forming the basis of the primary trial manuscript used data collected at study visits up to and including the date when the last enrolled participant completed the week 26 study visit (September 25. 2023). Another final analysis was performed using data collected at study visits up to the date when the last enrolled participant completed the week 65 assessment.\n\nStudy visits included physical examinations; blood, urine, and/or sputum collection; chest X-rays; and electrocardiograms (ECG)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pulmonary TB (among participants with or without history of prior TB treatment) identified within 5 days prior to entry by:\n\n * At least one sputum specimen positive for M. tuberculosis by molecular TB assay (Xpert) or line probe assay \\[LPA\\]) OR\n * At least one sputum specimen positive (1+ or greater) for acid-fast bacilli (AFB) on smear microscopy\n * Note: TB diagnosis for purposes of meeting inclusion criterion can be from a study testing laboratory or from an outside laboratory, as long as it is from a sputum sample collected within 5 days prior to entry.\n* Pulmonary TB diagnosed without known INH resistance (e.g., by LPA or Xpert) and without known RIF resistance (e.g., by either LPA or Xpert).\n* Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, within 30 days prior to entry OR HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of \\>1,000 copies/mL are also acceptable as documentation of HIV-1 infection.\n* For participants living with HIV, CD4+ cell count ≥100 cells/mm\\^3, obtained within 30 days prior to study entry at any network-approved non-US laboratory that is Immunology Quality Assessment (IQA) certified.\n* For participants living with HIV must be currently receiving or planning to initiate antiretroviral therapy (ART) at or before study week 8.\n* A verifiable address or residence readily accessible to facilitate directly observed therapy (DOT), and willingness to inform the study team of any change of address during the treatment and follow-up period.\n* The following laboratory values obtained at or within 5 days prior to entry by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practice (GCLP) and participates in appropriate external quality assurance programs.\n\n * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n * Serum or plasma total bilirubin ≤2.5 times ULN\n * Serum or plasma creatinine ≤2 times ULN\n * Serum or plasma potassium ≥3.5 mEq/L and ≤5.5 mEq/L\n * Absolute neutrophil count (ANC) ≥650/mm\\^3\n * Hemoglobin ≥7.0 g/dL\n * Platelet count ≥50,000/mm\\^3\n* For females of reproductive potential, negative serum or urine pregnancy test within 5 days prior to entry by any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or is using a point of care (POC)/CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practice (GCLP) and participates in appropriate external quality assurance programs.\n* Female participants of reproductive potential must agree not to participate in the conception process (i.e., active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable nonhormonal method of contraception, as listed below, while on study treatment and for 30 days after stopping study medications.\n\n * Acceptable forms of contraception include:\n * Condoms\n * Intrauterine device or intrauterine system\n * Cervical cap with spermicide\n * Diaphragm with spermicide\n * Note: Hormonal birth control alone is not acceptable, as it may not be sufficiently reliable in combination with RPT or RIF.\n* Female participants who are not of reproductive potential must have documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, or bilateral oophorectomy or bilateral tubal ligation.\n* Documentation of Karnofsky performance score ≥50 within 30 days prior to entry.\n* Documentation of either the presence or absence of advanced disease as determined by chest X-ray within 5 days prior to entry.\n* Ability and willingness of participant to provide informed consent.\n\nExclusion Criteria:\n\n* More than 5 days of treatment directed against active TB for the current TB episode preceding study entry.\n* Pregnant or breast-feeding.\n* Unable to take oral medications.\n* Current receipt of clofazimine or bedaquiline or known receipt of clofazamine or bedaquiline at any time in the past.\n* Corrected QT based on the Fridericia correction method (QTcF) interval \\>450 ms for men or \\>470 ms for women within 30 days prior to entry.\n* Weight \\<30 kg.\n* Current or planned use within 6 months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors (other than EFV), elvitegravir/cobicistat, bictegravir, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine.\n* Current extrapulmonary TB, in the opinion of the site investigator.\n* Current or history of known personal or family long QT syndrome.\n* Known allergy/sensitivity or any hypersensitivity to components of study TB drugs or their formulation.\n* Active drug, alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Known history of acute intermittent porphyria.\n* Other medical conditions (e.g., severe uncontrolled diabetes, liver or kidney disease, blood disorders, peripheral neuritis, chronic diarrhea) in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.'}, 'identificationModule': {'nctId': 'NCT04311502', 'briefTitle': 'Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study', 'orgStudyIdInfo': {'id': 'ACTG A5362'}, 'secondaryIdInfos': [{'id': '30148', 'type': 'REGISTRY', 'domain': 'DAIDS-ES Registry Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Experimental', 'description': 'Participants received rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.', 'interventionNames': ['Drug: Rifapentine', 'Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Ethambutol', 'Drug: Clofazimine loading dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Standard of care', 'description': 'Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.', 'interventionNames': ['Drug: Rifampicin', 'Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Ethambutol']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: PK only subgroup', 'description': 'Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).', 'interventionNames': ['Drug: Rifapentine', 'Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Ethambutol', 'Drug: Clofazimine 100 MG']}], 'interventions': [{'name': 'Rifapentine', 'type': 'DRUG', 'description': '1200 mg once daily', 'armGroupLabels': ['Arm 1: Experimental', 'Arm C: PK only subgroup']}, {'name': 'Rifampicin', 'type': 'DRUG', 'description': '600 mg once daily', 'armGroupLabels': ['Arm 2: Standard of care']}, {'name': 'Isoniazid', 'type': 'DRUG', 'description': '300 mg once daily', 'armGroupLabels': ['Arm 1: Experimental', 'Arm 2: Standard of care', 'Arm C: PK only subgroup']}, {'name': 'Pyrazinamide', 'type': 'DRUG', 'description': '1000mg once daily if weight is 40 to \\<55kg; 1500mg once daily if weight is 55 to \\<71kg; 2000mg once if weight is ≥71kg', 'armGroupLabels': ['Arm 1: Experimental', 'Arm 2: Standard of care', 'Arm C: PK only subgroup']}, {'name': 'Ethambutol', 'type': 'DRUG', 'description': '800 mg once daily if weight is 40 to \\<55kg; 1200 mg once daily if weight is 55 to \\<71kg; 1600mg once if weight is ≥71kg', 'armGroupLabels': ['Arm 1: Experimental', 'Arm 2: Standard of care', 'Arm C: PK only subgroup']}, {'name': 'Clofazimine loading dose', 'type': 'DRUG', 'description': '300 mg once daily for 2 weeks (loading dose), then 100 mg once daily', 'armGroupLabels': ['Arm 1: Experimental']}, {'name': 'Clofazimine 100 MG', 'type': 'DRUG', 'description': '100 mg once daily', 'armGroupLabels': ['Arm C: PK only subgroup']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HT-6110', 'city': 'Port-au-Prince', 'country': 'Haiti', 'facility': 'Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS', 'geoPoint': {'lat': 18.54349, 'lon': -72.33881}}, {'zip': '411001', 'city': 'Pune', 'country': 'India', 'facility': 'Byramjee Jeejeebhoy Medical College (BJMC) CRS', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Lilongwe', 'state': 'Central Region', 'country': 'Malawi', 'facility': 'Malawi CRS', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'zip': '1131', 'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Blantyre CRS', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}, {'zip': '4013', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'CAPRISA eThekwini CRS', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Milton Park CRS', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'John Metcalfe, MD, PhD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) Network by NIH.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie results in the publication, after deidentification.', 'accessCriteria': '* With whom?\n\n * Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.\n* For what types of analyses?\n\n * To achieve aims in the proposal approved by the ACTG Group.\n* By what mechanism will data be made available?\n\n * Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}