Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-01 @ 6:29 PM
Study NCT ID:
NCT00885703
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2009-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016919', 'term': 'Meningitis, Cryptococcal'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D016921', 'term': 'Meningitis, Fungal'}, {'id': 'D020314', 'term': 'Central Nervous System Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D000666', 'term': 'Amphotericin B'}, {'id': 'C059765', 'term': 'amphotericin B, deoxycholate drug combination'}, {'id': 'C068538', 'term': 'liposomal amphotericin B'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG Clinicaltrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, '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}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from study entry until end of study (24 weeks).', 'description': 'The protocol required reporting of all Grade \\>= 3 signs/symptoms, all Grade \\>= 2 laboratory toxicities, all estimated creatinine clearance values, and all signs/symptoms or laboratory toxicities that lead to a change in treatment, regardless of grade, were recorded. All diagnoses were recorded.\n\nThe Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/)', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: 1200mg Fluconazole', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 9, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Stage 1: 1600mg Fluconazole', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'deathsNumAffected': 7, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Stage 1: 2000mg Fluconazole', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 8, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Stage 1: Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight", 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 7, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Stage 2: 1600mg Fluconazole', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 7, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': 'Stage 2: 2000mg Fluconazole', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 8, 'seriousNumAffected': 12}, {'id': 'EG006', 'title': 'Stage 2: Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight", 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 4, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anorectal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Encephalitis cytomegalovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meningitis cryptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meningitis tuberculous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tuberculosis gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Immune reconstitution inflammatory syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Disseminated cryptococcosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Meningitis cryptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': "Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Superior sagittal sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1, Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Stage 1, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Stage 1, Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Stage 1, Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}, {'id': 'OG004', 'title': 'Stage 2, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG005', 'title': 'Stage 2, Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG006', 'title': 'Stage 2, Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'pValueComment': 'Analysis did not adjust for multiple comparisons.', 'groupDescription': 'Testing discontinuation of any dose Fluconazole (pooled by treatment and dose) versus discontinuation of Ampho B (pooled). The null hypothesis is the two treatments have the same proportion of discontinuation.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from study entry through Week10', 'description': 'Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2\n\nDiscontinuation includes discontinuing for any reason, including progression of symptoms, death, etc.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis in safety population (see study detailed description for details)'}, {'type': 'PRIMARY', 'title': 'Categorized Quantitative Culture Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'title': 'Week 0', 'categories': [{'title': 'CM Positive', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}, {'title': 'CM Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'CM Negative after switching treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Died', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Lost to Follow-up', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'title': 'CM Positive', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}, {'title': 'CM Negative', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'title': 'CM Negative after switching treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Died', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Lost to Follow-up', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'categories': [{'title': 'CM Positive', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'CM Negative', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}, {'title': 'CM Negative after switching treatment', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Died', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Lost to Follow-up', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Among 4 treatment arms, comparison of three categorical groups: (CM negative, CM negative after switching treatment, and CM Positive/Died/Lost to Follow-up) at week 10. The null hypothesis is the 4 treatment arms have no differences at week 10.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At entry, Week 2, and Week 10', 'description': 'Count of participants who were CM negative (had no cryptococcal growth), CM negative after switching treatment (switched from Fluconazole to Ampho B or vice versa and later became CM negative), CM positive, Died, Lost to follow-up. Note: CM positive means continued to have cryptococcal growth.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose. Analysis in efficacy population (see study detailed description for details).'}, {'type': 'PRIMARY', 'title': 'Change in Log10 Quantitative CSF Culture Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'categories': [{'measurements': [{'value': '-1.51', 'groupId': 'OG000', 'lowerLimit': '-2.90', 'upperLimit': '-0.91'}, {'value': '-2.51', 'groupId': 'OG001', 'lowerLimit': '-4.00', 'upperLimit': '-1.44'}, {'value': '-1.78', 'groupId': 'OG002', 'lowerLimit': '-3.24', 'upperLimit': '-1.00'}, {'value': '-2.81', 'groupId': 'OG003', 'lowerLimit': '-4.09', 'upperLimit': '-1.92'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Comparison of change in quantitative CSF culture among 4 treatment arms. The null hypothesis is the 4 treatment arms have the same change in CSF culture from entry to week 2.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Entry and Week 2', 'description': 'Change in quantitative CSF (cerebrospinal fluid) cultures.\n\nNote: No further CSF specimens are drawn following a negative culture. Thus, only week 2 CSF cultures are considered in this analysis.', 'unitOfMeasure': 'Log10 CFU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose. Analysis done in efficacy population (see study detailed description for details). Excludes participants who did not have a week 2 observation.'}, {'type': 'PRIMARY', 'title': 'Kaplan Meier (KM) Proportion of Participant Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.60'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.43'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '0.49'}, {'value': '0.24', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.36'}]}]}], 'analyses': [{'pValue': '0.0894', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Analysis did not adjust for multiple comparisons.', 'groupDescription': 'Comparison of survival from entry to week 24 between Fluconazole 1200mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4828', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'Analysis did not adjust for multiple comparisons.', 'groupDescription': 'Comparison of survival from entry to week 24 between Fluconazole 1600mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1766', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'Analysis did not adjust for multiple comparisons.', 'groupDescription': 'Comparison of survival from entry to week 24 between Fluconazole 2000mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Kaplan Meier Proportion of participants who died over study with 90% Confidence Intervals.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose in the safety population (see study detailed description for details).'}, {'type': 'SECONDARY', 'title': 'Results of the Neurological Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Score < 15', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Score = 15', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Score < 15', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Score = 15', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Score < 15', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Score = 15', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at study entry, Week 2, and Week 10', 'description': 'Results from Glasgow Coma Score, which provides assessment of impairment of conscious level in response to defined stimuli. Min score of 0 and max score of 15 (no mental impairment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose. Safety population (see study detailed description for details).'}, {'type': 'SECONDARY', 'title': 'Results of Functional Status Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'title': 'Baseline Had full time work status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Entry Had full time work status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Week 10 Had full time work status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 Had full time work status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Baseline Had functional ability to work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Entry Had functional ability to work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Week 10 Had functional ability to work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 Had functional ability to work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24', 'description': "Functional assessment of work status and ability. Consists of 2 measures: 1) Does participants have full time work status 2) Does participant have functional ability to work.\n\nThe measure from 6 week before enrollment will be referred to as 'baseline'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose. Safety population (see study detailed description for details).'}, {'type': 'SECONDARY', 'title': 'Length of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '21'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '28'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '13', 'upperLimit': '36'}, {'value': '18.5', 'groupId': 'OG003', 'lowerLimit': '17', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured from study entry through Week 10', 'description': 'Duration of first hospitalization in days starting at entry in safety population.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose in safety population (see study detailed description for details). Fluconazole 2000mg arm had one participant data missing (was not admitted to hospital at study entry).'}, {'type': 'SECONDARY', 'title': 'Number of Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'categories': [{'title': '1 hospital admission', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}, {'title': '2 hospital admissions', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': '3 hospital admissions', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Count of number of times a participant was admitted to the hospital.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose in safety population (see study detailed description for details).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression of Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Progression of symptoms is defined as:\n\n* Died (including early deaths)\n* Discontinued Fluconazole and started ampho B\n* Had a positive cryptococcal culture at week 10\n* Microbiological Failure (i.e., relapse of CM)\n* Complication of CM (e.g., obstructive hydrocephalus or vascular complications such as venous or arterial thrombosis)\n* CM IRIS causing increased inflammation after ART exposure\n* New CNS Ol (e.g., toxoplasmosis, PML, CNS lymphoma)\n* Possibly related to CM but mechanism indeterminate\n* Other defined complication unrelated to CM', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose. Analysis done in efficacy population (see detailed study description for details).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CNS IRIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Number of participants who were diagnosed with CNS immune reconstitution inflammatory syndrome (IRIS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose in study population (see study detailed description for details).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 and 4 Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG001', 'title': 'Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG002', 'title': 'Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'OG003', 'title': 'Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'classes': [{'title': 'Sign/Symptom Events', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Laboratory Events', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Occurrence of grade 3 (severe) and 4 (life-threatening) sign and symptoms events (as defined by FSTRF Appendix 29)\n\nOccurrence of grade 3 (severe) and 4 (life-threatening) laboratory events (as defined by FSTRF Appendix 76)\n\nSee DAIDS AE Grading table V1.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms pooled by dose in safety population (see study detailed description for details).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1, Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'FG001', 'title': 'Stage 1, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'FG002', 'title': 'Stage 1, Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'FG003', 'title': 'Stage 1, Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}, {'id': 'FG004', 'title': 'Stage 2, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'FG005', 'title': 'Stage 2, Fulconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'FG006', 'title': 'Stage 2, Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '24'}, {'groupId': 'FG006', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Ineligible (no CM)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study opened on February 19, 2010. The first participant enrolled on April 16, 2010. Stage 1 closed on September 5, 2013. A5225 Stage 2 opened on September 15, 2014 and the first participant enrolled on February 2, 2015. Stage 2 closed on August 19, 2016. Ten sites enrolled participants (1 domestic, 9 international).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1, Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'BG001', 'title': 'Stage 1, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'BG002', 'title': 'Stage 1, Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'BG003', 'title': 'Stage 1, Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole in Stage 1\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}, {'id': 'BG004', 'title': 'Stage 2, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'BG005', 'title': 'Stage 2, Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.'}, {'id': 'BG006', 'title': 'Stage 2, Ampho B', 'description': "Participants receive Amphotericin B followed by Fluconazole in Stage 2\n\nFluconazole: Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.\n\nAmphotericin B: Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '47'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '39'}, {'value': '38', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '48'}, {'value': '35.5', 'groupId': 'BG003', 'lowerLimit': '30', 'upperLimit': '41'}, {'value': '32.5', 'groupId': 'BG004', 'lowerLimit': '29.5', 'upperLimit': '35.5'}, {'value': '33.5', 'groupId': 'BG005', 'lowerLimit': '29', 'upperLimit': '38'}, {'value': '37.5', 'groupId': 'BG006', 'lowerLimit': '34', 'upperLimit': '40'}, {'value': '36', 'groupId': 'BG007', 'lowerLimit': '30', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '78', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '90', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black Non-Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '143', 'groupId': 'BG007'}]}]}, {'title': 'Hispanic (regardless of Race)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}]}]}, {'title': 'Asian, Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}]}, {'title': 'Uganda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}]}, {'title': 'Zimbabwe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}]}]}, {'title': 'Kenya', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}]}, {'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}, {'title': 'Peru', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}, {'title': 'India', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'BG000', 'lowerLimit': '42.0', 'upperLimit': '52.2'}, {'value': '50.5', 'groupId': 'BG001', 'lowerLimit': '44.0', 'upperLimit': '65.0'}, {'value': '51.9', 'groupId': 'BG002', 'lowerLimit': '43.5', 'upperLimit': '58.5'}, {'value': '56.8', 'groupId': 'BG003', 'lowerLimit': '47.5', 'upperLimit': '64.1'}, {'value': '49.8', 'groupId': 'BG004', 'lowerLimit': '44.5', 'upperLimit': '60.0'}, {'value': '55.0', 'groupId': 'BG005', 'lowerLimit': '51.6', 'upperLimit': '59.1'}, {'value': '52.5', 'groupId': 'BG006', 'lowerLimit': '48.5', 'upperLimit': '60.1'}, {'value': '52.0', 'groupId': 'BG007', 'lowerLimit': '44.7', 'upperLimit': '59.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'BG000', 'lowerLimit': '15.6', 'upperLimit': '19.6'}, {'value': '19.6', 'groupId': 'BG001', 'lowerLimit': '17.3', 'upperLimit': '21.8'}, {'value': '18.3', 'groupId': 'BG002', 'lowerLimit': '17.2', 'upperLimit': '22.7'}, {'value': '19.8', 'groupId': 'BG003', 'lowerLimit': '16.3', 'upperLimit': '24.3'}, {'value': '18.7', 'groupId': 'BG004', 'lowerLimit': '17.1', 'upperLimit': '20.3'}, {'value': '19.8', 'groupId': 'BG005', 'lowerLimit': '18.6', 'upperLimit': '22.5'}, {'value': '19.6', 'groupId': 'BG006', 'lowerLimit': '17.5', 'upperLimit': '22.9'}, {'value': '18.9', 'groupId': 'BG007', 'lowerLimit': '16.9', 'upperLimit': '21.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD4+', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'title': '< 50 cells/mm^3', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '112', 'groupId': 'BG007'}]}, {'title': '50 - <100 cells/mm^3', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '36', 'groupId': 'BG007'}]}, {'title': '100 - <200 cells/mm^3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}]}, {'title': '200+ cells/mm^3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV-1 RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'BG000', 'lowerLimit': '5.1', 'upperLimit': '6.0'}, {'value': '5.6', 'groupId': 'BG001', 'lowerLimit': '5.1', 'upperLimit': '5.8'}, {'value': '5.5', 'groupId': 'BG002', 'lowerLimit': '5.2', 'upperLimit': '5.9'}, {'value': '5.4', 'groupId': 'BG003', 'lowerLimit': '5.2', 'upperLimit': '5.7'}, {'value': '5.2', 'groupId': 'BG004', 'lowerLimit': '4.9', 'upperLimit': '5.5'}, {'value': '4.9', 'groupId': 'BG005', 'lowerLimit': '2.8', 'upperLimit': '5.4'}, {'value': '4.6', 'groupId': 'BG006', 'lowerLimit': '3.5', 'upperLimit': '5.5'}, {'value': '5.3', 'groupId': 'BG007', 'lowerLimit': '4.7', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'log10(copies/mL)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Glasgow Coma Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '167', 'groupId': 'BG007'}]}], 'categories': [{'title': 'GCS <15', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}]}, {'title': 'GCS =15', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '151', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Glasgow Coma Score provides an assessment of impairment of conscious level in response to defined stimuli. The GCS is on a scale from 0=worst to 15=best.', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant missing baseline Glasgow Coma Score.'}, {'title': 'Quantitative Cryptococcal Meningitis Culture', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '5.18', 'groupId': 'BG000', 'lowerLimit': '4.23', 'upperLimit': '6.02'}, {'value': '4.45', 'groupId': 'BG001', 'lowerLimit': '3.98', 'upperLimit': '5.09'}, {'value': '5.15', 'groupId': 'BG002', 'lowerLimit': '4.25', 'upperLimit': '5.80'}, {'value': '4.37', 'groupId': 'BG003', 'lowerLimit': '3.33', 'upperLimit': '5.23'}, {'value': '5.34', 'groupId': 'BG004', 'lowerLimit': '4.31', 'upperLimit': '5.47'}, {'value': '4.29', 'groupId': 'BG005', 'lowerLimit': '2.05', 'upperLimit': '5.32'}, {'value': '5.14', 'groupId': 'BG006', 'lowerLimit': '3.40', 'upperLimit': '5.42'}, {'value': '5.04', 'groupId': 'BG007', 'lowerLimit': '3.80', 'upperLimit': '5.42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Log10 CFU/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Anti-Retroviral Therapy (ART) Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'title': 'On ART', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '31', 'groupId': 'BG007'}]}, {'title': 'Not on ART', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '137', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Opportunistic Infections', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'title': 'One or more opportunistic infections', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '68', 'groupId': 'BG007'}]}, {'title': 'No opportunistic infections', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '100', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mini Mental Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '158', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '26'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '26'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '26'}, {'value': '26', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '26'}, {'value': '26', 'groupId': 'BG004', 'lowerLimit': '21', 'upperLimit': '26'}, {'value': '26', 'groupId': 'BG005', 'lowerLimit': '19', 'upperLimit': '26'}, {'value': '25.5', 'groupId': 'BG006', 'lowerLimit': '20', 'upperLimit': '26'}, {'value': '26', 'groupId': 'BG007', 'lowerLimit': '22', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Mini Mental Status is a 26-point questionnaire that is used to measure cognitive impairment. Scale is 0=worst to 26=best.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Not all participants were able to complete a Mini Mental Status at baseline.'}, {'title': 'Opening Pressure (from Lumbar Pucture)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '165', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000', 'lowerLimit': '105', 'upperLimit': '300'}, {'value': '200', 'groupId': 'BG001', 'lowerLimit': '150', 'upperLimit': '290'}, {'value': '350', 'groupId': 'BG002', 'lowerLimit': '180', 'upperLimit': '550'}, {'value': '190', 'groupId': 'BG003', 'lowerLimit': '120', 'upperLimit': '300'}, {'value': '200', 'groupId': 'BG004', 'lowerLimit': '150', 'upperLimit': '254'}, {'value': '190', 'groupId': 'BG005', 'lowerLimit': '120', 'upperLimit': '235'}, {'value': '303', 'groupId': 'BG006', 'lowerLimit': '250', 'upperLimit': '485'}, {'value': '210', 'groupId': 'BG007', 'lowerLimit': '141', 'upperLimit': '320'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm H20', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Not all participants were able to have a lumbar puncture at entry.'}, {'title': 'White Blood Cell count (from CSF)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '153', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '500'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '100'}, {'value': '17', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '310'}, {'value': '26', 'groupId': 'BG003', 'lowerLimit': '15', 'upperLimit': '133'}, {'value': '19', 'groupId': 'BG004', 'lowerLimit': '8', 'upperLimit': '33'}, {'value': '16', 'groupId': 'BG005', 'lowerLimit': '12', 'upperLimit': '89'}, {'value': '13', 'groupId': 'BG006', 'lowerLimit': '8', 'upperLimit': '53'}, {'value': '19', 'groupId': 'BG007', 'lowerLimit': '9', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.'}, {'title': 'Albumin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '167', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000', 'lowerLimit': '2.6', 'upperLimit': '3.3'}, {'value': '3.2', 'groupId': 'BG001', 'lowerLimit': '3.1', 'upperLimit': '3.6'}, {'value': '3.3', 'groupId': 'BG002', 'lowerLimit': '2.9', 'upperLimit': '3.6'}, {'value': '3.2', 'groupId': 'BG003', 'lowerLimit': '2.8', 'upperLimit': '3.6'}, {'value': '3.1', 'groupId': 'BG004', 'lowerLimit': '2.8', 'upperLimit': '3.2'}, {'value': '3.1', 'groupId': 'BG005', 'lowerLimit': '2.7', 'upperLimit': '3.6'}, {'value': '3.1', 'groupId': 'BG006', 'lowerLimit': '2.7', 'upperLimit': '3.6'}, {'value': '3.2', 'groupId': 'BG007', 'lowerLimit': '2.8', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Not all participants had an albumin measurement.'}, {'title': 'ALT (Alanine Aminotransferase)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'BG000', 'lowerLimit': '11.0', 'upperLimit': '22.8'}, {'value': '19.0', 'groupId': 'BG001', 'lowerLimit': '13.0', 'upperLimit': '29.2'}, {'value': '24.7', 'groupId': 'BG002', 'lowerLimit': '14.0', 'upperLimit': '41.8'}, {'value': '21.5', 'groupId': 'BG003', 'lowerLimit': '11.7', 'upperLimit': '32.7'}, {'value': '25.2', 'groupId': 'BG004', 'lowerLimit': '17.4', 'upperLimit': '38.0'}, {'value': '24.1', 'groupId': 'BG005', 'lowerLimit': '14.5', 'upperLimit': '32.1'}, {'value': '18.1', 'groupId': 'BG006', 'lowerLimit': '14.5', 'upperLimit': '35.3'}, {'value': '20.6', 'groupId': 'BG007', 'lowerLimit': '14.0', 'upperLimit': '32.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Creatinine Clearance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '168', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'BG000', 'lowerLimit': '79.5', 'upperLimit': '112.1'}, {'value': '94.5', 'groupId': 'BG001', 'lowerLimit': '79.3', 'upperLimit': '106.3'}, {'value': '94.2', 'groupId': 'BG002', 'lowerLimit': '72.7', 'upperLimit': '115.2'}, {'value': '102.3', 'groupId': 'BG003', 'lowerLimit': '81.9', 'upperLimit': '135.5'}, {'value': '94.0', 'groupId': 'BG004', 'lowerLimit': '68.2', 'upperLimit': '104.0'}, {'value': '98.8', 'groupId': 'BG005', 'lowerLimit': '67.3', 'upperLimit': '121.8'}, {'value': '94.4', 'groupId': 'BG006', 'lowerLimit': '77.6', 'upperLimit': '113.5'}, {'value': '95.0', 'groupId': 'BG007', 'lowerLimit': '75.0', 'upperLimit': '113.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Cryptococcal Antigen (CrAG) Titer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}, {'value': '158', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '756', 'groupId': 'BG000', 'lowerLimit': '256', 'upperLimit': '8192'}, {'value': '128', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '1024'}, {'value': '815.5', 'groupId': 'BG002', 'lowerLimit': '125', 'upperLimit': '8192'}, {'value': '1050', 'groupId': 'BG003', 'lowerLimit': '160', 'upperLimit': '4096'}, {'value': '256', 'groupId': 'BG004', 'lowerLimit': '20', 'upperLimit': '1024'}, {'value': '128', 'groupId': 'BG005', 'lowerLimit': '16', 'upperLimit': '2048'}, {'value': '416', 'groupId': 'BG006', 'lowerLimit': '128', 'upperLimit': '4096'}, {'value': '452.5', 'groupId': 'BG007', 'lowerLimit': '32', 'upperLimit': '2405'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'titers', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Not all participants had a CrAG titer observed at baseline.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1 was the dose escalation phase which used a sequential model. Phase 2 was the dose validation phase which used a parallel model. Analyses combine arms from Phase 1 and Phase 2, as appropriate, for validation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2009-04-20', 'resultsFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2009-04-20', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-12', 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B', 'timeFrame': 'Measured from study entry through Week10', 'description': 'Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2\n\nDiscontinuation includes discontinuing for any reason, including progression of symptoms, death, etc.'}, {'measure': 'Categorized Quantitative Culture Results', 'timeFrame': 'At entry, Week 2, and Week 10', 'description': 'Count of participants who were CM negative (had no cryptococcal growth), CM negative after switching treatment (switched from Fluconazole to Ampho B or vice versa and later became CM negative), CM positive, Died, Lost to follow-up. Note: CM positive means continued to have cryptococcal growth.'}, {'measure': 'Change in Log10 Quantitative CSF Culture Results', 'timeFrame': 'Entry and Week 2', 'description': 'Change in quantitative CSF (cerebrospinal fluid) cultures.\n\nNote: No further CSF specimens are drawn following a negative culture. Thus, only week 2 CSF cultures are considered in this analysis.'}, {'measure': 'Kaplan Meier (KM) Proportion of Participant Mortality', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Kaplan Meier Proportion of participants who died over study with 90% Confidence Intervals.'}], 'secondaryOutcomes': [{'measure': 'Results of the Neurological Examination', 'timeFrame': 'Measured at study entry, Week 2, and Week 10', 'description': 'Results from Glasgow Coma Score, which provides assessment of impairment of conscious level in response to defined stimuli. Min score of 0 and max score of 15 (no mental impairment).'}, {'measure': 'Results of Functional Status Evaluation', 'timeFrame': 'Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24', 'description': "Functional assessment of work status and ability. Consists of 2 measures: 1) Does participants have full time work status 2) Does participant have functional ability to work.\n\nThe measure from 6 week before enrollment will be referred to as 'baseline'."}, {'measure': 'Length of Hospitalization', 'timeFrame': 'Measured from study entry through Week 10', 'description': 'Duration of first hospitalization in days starting at entry in safety population.'}, {'measure': 'Number of Hospital Admissions', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Count of number of times a participant was admitted to the hospital.'}, {'measure': 'Number of Participants With Progression of Symptoms', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Progression of symptoms is defined as:\n\n* Died (including early deaths)\n* Discontinued Fluconazole and started ampho B\n* Had a positive cryptococcal culture at week 10\n* Microbiological Failure (i.e., relapse of CM)\n* Complication of CM (e.g., obstructive hydrocephalus or vascular complications such as venous or arterial thrombosis)\n* CM IRIS causing increased inflammation after ART exposure\n* New CNS Ol (e.g., toxoplasmosis, PML, CNS lymphoma)\n* Possibly related to CM but mechanism indeterminate\n* Other defined complication unrelated to CM'}, {'measure': 'Number of Participants With CNS IRIS', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Number of participants who were diagnosed with CNS immune reconstitution inflammatory syndrome (IRIS)'}, {'measure': 'Number of Participants With Grade 3 and 4 Adverse Events', 'timeFrame': 'Measured from study entry through Week 24', 'description': 'Occurrence of grade 3 (severe) and 4 (life-threatening) sign and symptoms events (as defined by FSTRF Appendix 29)\n\nOccurrence of grade 3 (severe) and 4 (life-threatening) laboratory events (as defined by FSTRF Appendix 76)\n\nSee DAIDS AE Grading table V1.0'}]}, 'conditionsModule': {'keywords': ['CM', 'HIV', 'Meningitis'], 'conditions': ['Cryptococcal Meningitis', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '19365271', 'type': 'BACKGROUND', 'citation': 'Bicanic T, Meintjes G, Rebe K, Williams A, Loyse A, Wood R, Hayes M, Jaffar S, Harrison T. Immune reconstitution inflammatory syndrome in HIV-associated cryptococcal meningitis: a prospective study. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):130-4. doi: 10.1097/QAI.0b013e3181a56f2e.'}, {'pmid': '19345042', 'type': 'BACKGROUND', 'citation': 'Pappalardo MC, Szeszs MW, Martins MA, Baceti LB, Bonfietti LX, Purisco SU, Baez AA, Melhem MS. Susceptibility of clinical isolates of Cryptococcus neoformans to amphotericin B using time-kill methodology. Diagn Microbiol Infect Dis. 2009 Jun;64(2):146-51. doi: 10.1016/j.diagmicrobio.2009.02.007. Epub 2009 Apr 2.'}, {'pmid': '19304977', 'type': 'BACKGROUND', 'citation': 'Seddon J, Mangeya N, Miller RF, Corbett EL, Ferrand RA. Recurrence of cryptococcal meningitis in HIV-infected patients following immune reconstitution. Int J STD AIDS. 2009 Apr;20(4):274-5. doi: 10.1258/ijsa.2008.008312.'}, {'pmid': '36780493', 'type': 'DERIVED', 'citation': 'Lalloo UG, Komarow L, Aberg JA, Clifford DB, Hogg E, McKhann A, Bukuru A, Lagat D, Pillay S, Mave V, Supparatpinyo K, Samaneka W, Langat D, Ticona E, Badal-Faesen S, Larsen RA; ACTG A5225 Team. Higher Dose Oral Fluconazole for the Treatment of AIDS-related Cryptococcal Meningitis (HIFLAC)-report of A5225, a multicentre, phase I/II, two-stage, dose-finding, safety, tolerability and efficacy randomised, amphotericin B-controlled trial of the AIDS Clinical Trials Group. PLoS One. 2023 Feb 13;18(2):e0281580. doi: 10.1371/journal.pone.0281580. eCollection 2023.'}], 'seeAlsoLinks': [{'url': 'https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf?sfvrsn=6', 'label': 'DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004; Clarification, August 2009'}, {'url': 'https://rsc.tech-res.com/docs/default-source/safety/manual_for_expedited_reporting_aes_to_daids_v2.pdf?sfvrsn=10', 'label': 'Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010'}]}, 'descriptionModule': {'briefSummary': 'Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal cord, caused by the fungus Cryptococcus neoformans. CM most often affects people with compromised immune systems, like those with advanced HIV infection. This study explored the safety, tolerability, and therapeutic effect of a new treatment regimen with high-dose fluconazole for management of CM in HIV-infected patients.', 'detailedDescription': 'CM is the most common central nervous system (CNS) complication of AIDS worldwide and accounts for up to a third of all deaths from AIDS in many developing countries. Current treatments for CM are lacking in both effectiveness and accessibility, particularly in limited-resources settings. Conventional therapies utilizing an amphotericin B deoxycholate (ampho B)-based regimen require maintaining intravenous access (IV) and monitoring and treating any associated complications. The price to acquire ampho B can also be prohibitive to successful treatment. Cumulatively, a treatment course with ampho B is neither cost effective nor administratively efficient, leaving patients either untreated or inadequately treated with low-dose regimens of fluconazole alone.\n\nFluconazole is widely available, inexpensive, can be given orally, has a demonstrated safety profile over a broad range of doses, and has proven activity against the fungus that causes CM, Cryptococcus neoformans. All of these factors make fluconazole a potential treatment option for a wide range of people. However, at its present recommended dosage, fluconazole is only expected to be successful in 34% to 42% of patients. This rate is lower than regimens combining fluconazole with other treatments including flucytosine or ampho B.\n\nThe purpose of this study was to evaluate whether high-dose fluconazole is safe and effective for the treatment of CM for up to 10 weeks. This study also collected information about treating CM with ampho B (either alone or with another drug, either flucytosine or fluconazole).\n\nFor this study, 168 HIV-infected people with CM participated for a duration of 24 weeks. This study proceeded with 2 stages and each stage consisted of up to 4 steps. Participants could take part in only one stage of the study. Stage 1 measured the maximum tolerated dose (MTD) of fluconazole in participants. Stage 2 consisted of dose validation and safety monitoring.\n\nIn Stage 1, participants were randomly assigned to receive either fluconazole only or an ampho B-based regimen (a regimen that is either ampho B alone or ampho B in combination with 5-fluorocytosine or fluconazole, according to the local standard of care).Three doses of fluconazole were tested, and the MTD was found to be 2000 mg/day. The two higher doses of fluconazole tested in Stage 1 (1600 mg/day and 2000 mg/day doses) were tested further in Stage 2 of the study.\n\nParticipants enrolled in Stage 2 were randomly assigned to receive treatment with either fluconazole only (at one of the 2 doses (1600 mg/day or 2000 mg/day) found to be safe in Stage 1) or an ampho B-based regimen.\n\nAfter randomization in Step 1, participants in both Stage 1 and Stage 2 could be enrolled in up to three additional steps. In Step 2, participants who were randomly assigned to receive the ampho B-based regimen and who were intolerant to the regimen (experienced a treatment limiting toxicity \\[TLT\\]) received fluconazole (400-800mg daily). Participants who received study-provided fluconazole in Step 1 or in Step 2 could be enrolled in Step 3 if they had a negative cerebrospinal fluid (CSF) culture. Participants in Step 3 received fluconazole (400mg daily) until Week 10. At Week 10, all participants were enrolled in Step 4 and received a daily dose of fluconazole of 200mg until the end of the study (Week 24). Participants in both stages beginning treatment with ampho B received daily ampho B intravenously for up to 2 weeks.\n\nBefore entering the study, potential participants attended a screening visit where they had CSF collected via lumbar puncture. HIV testing was also conducted, along with clinical assessments, and a health and medical history questionnaire. Participants had blood collection, an electrocardiogram (ECG), and a pregnancy test (if applicable) at that visit. Once accepted into the study, participants again answered questions about their health and medication history; had a complete physical exam, blood collection, HIV testing, neurological exam, lumbar puncture, and ECG; and may have had a pregnancy test (if applicable).\n\nStudy visits occurred during Weeks 1 (at Days 1, 4, and 7), 2, 4, 6, 8, 10, and 24, and extra visits could occur for individualized reasons. Total study duration was 24 weeks. Plasma, urine, serum, and CSF samples were collected from all participants and stored for possible future use.\n\nNote on efficacy population versus safety population: After entering the study, participants had their CM diagnosis confirmed by testing of the CSF collected via lumbar puncture. Confirmation could take up to 2 weeks after study entry. Due to the mortality rate of CM, participants received treatment before CM diagnosis confirmation. Post-entry 12 participants either reported non-confirmatory baseline results making them ineligible. An additional 2 participants were found to be ineligible for the study but died prior to being found ineligible (one had non-confirmatory baseline results, one was on a disallowed medication) All participants (n=168) are included in the safety population. Participants who were ineligible after study entry were excluded from the efficacy population (n=16). The efficacy population had 154 participants. Outcomes will specify if the efficacy population is used instead of the safety population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - Step 1\n\n* CM documented either by a positive CSF cryptococcal culture, a positive CSF India ink preparation, or a positive CSF cryptococcal antigen latex agglutination test within 7 days prior to entry. More information on this criterion can be found in the protocol.\n* CSF collection for quantitative cryptococcal culture within 72 hours prior to study entry or planned to be performed at study entry\n* HIV-1 infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by or within 10 days after study entry by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, by HIV-1 antigen, or by plasma HIV-1 RNA viral load. More information on this criterion can be found in the protocol.\n* Ability to take oral medications. NOTE: Administration of fluconazole tablets via nasogastric tube is permitted.\n* For patients with a co-morbid complication of HIV, including opportunistic infections, reasonable certainty that the site investigator will be able to perform CSF sampling and manage expected study drug toxicities. More information on this criterion can be found in the protocol.\n* For female participants of reproductive potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months \\[i.e., who have had menses within the preceding 24 months, or have not undergone surgical sterilization, for example, a hysterectomy, or bilateral oophorectomy or salpingotomy\\]) a negative serum or urine pregnancy test result must be obtained within 2 days prior to study entry\n* All participants must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).\n* If participating in sexual activity that could lead to pregnancy, female study participants must agree to the simultaneous use of two forms of contraception (listed in protocol) during sexual activity, and male study participants must agree to use a condom during such sexual activity. This requirement continues while the study participant is on study treatment and for 6 weeks after fluconazole has been discontinued. More information on this criterion can be found in the protocol.\n* Study participants who are not of reproductive potential (defined as women who have been post-menopausal for at least 24 consecutive months, women who have undergone surgical sterilization \\[e.g., hysterectomy, or bilateral oophorectomy or salpingectomy\\], or men who have documented azoospermia) are eligible without the requirement to use contraceptives. More information on this criterion can be found in the protocol.\n* Willingness and ability to adhere to dose schedules and mandatory procedures\n* Measured or calculated creatinine clearance of 50 mL/min or more within 3 days prior to study entry. More information on this criterion can be found in the protocol.\n* The following laboratory values within 3 days prior to study entry: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase less than or equal to 5 times the upper limit of normal (ULN); total bilirubin less than or equal to 2.5 times ULN; absolute neutrophil count (ANC) equal to or greater than 750/mm\\^3; platelet count equal to or greater than 50,000/mm\\^3; hemoglobin equal to or greater than 7.0 g/dL\n* Ability and willingness of the participant or legal guardian/representative to give informed consent\n* Availability at the site for at least 2 weeks of its standard-of-care ampho B-based regimen\n\nExclusion Criteria - Step 1\n\n* Expected survival of 2 weeks or less, in the opinion of the site investigator and, if available, the primary care provider\n* For patients with a comorbid complication of HIV, anticipated difficulty, in the opinion of the site investigator, in judging response to study treatment as a result of the comorbid complication or the drugs used to treat it\n* Breastfeeding\n* A prior episode of CM, either as indicated by patient or as noted in patient medical records\n* Use of certain drugs within specified time periods. More information on this criterion can be found in the study protocol.\n* For candidates who are currently taking nevirapine, the inability to discontinue nevirapine and replace it with a drug that does not have fluconazole drug interactions at or by study entry in the event they are randomized to a high-dose fluconazole treatment arm. More information on this criterion can be found in the study protocol.\n* Known allergy, sensitivity to, or intolerance of fluconazole or other imidazole or triazole compounds or to ampho B or other components of the standard of care ampho B based regimen\n* History of clinically significant cardiac disease, in the opinion of the site investigator, including symptoms of ischemia, coronary artery disease, congestive heart failure, or arrhythmia\n* ECG with QTc interval greater than 450 msec within 7 days prior to study entry. More information on this criterion can be found in the study protocol.\n* History of CNS disorder (excluding mood disorders) or concurrent CNS disorder(s) that, in the opinion of the investigator, would interfere with assessment of efficacy (e.g., ability to perform CSF sampling) such as lymphoma, neurocysticercosis, or toxoplasmosis\n* Receipt of investigational drug therapy within 30 days prior to study entry without prior approval of the A5225/HiFLAC core team\n* Active drug or alcohol use, dependence, or other conditions that in the opinion of the site investigator would jeopardize the safety of a participant in the study or would render the person unable to comply with the study plan\n\nInclusion Criteria - Step 2\n\n* Randomization to an ampho B-based regimen in Step 1\n* Receipt of at least one dose of ampho B-based regimen in Step 1\n* Premature discontinuation of ampho B in response to the occurrence of any treatment-limiting toxicity, as described in Section 5 of the A5225/HiFLAC manual of operations (MOPS)\n\nExclusion Criteria - Step 2\n\n* Receipt of fluconazole monotherapy in Step 1\n* Receipt of 8.4 mg/kg or more of ampho B\n* At or beyond Day 17 in Step 1\n\nInclusion Criteria - Step 3\n\n* For participants in Step 1 who are currently receiving study-provided fluconazole and have no plans to discontinue study treatment (except as noted below), a negative CSF culture after 2 weeks incubation from a sample obtained at or before Week 6 (Days 35-49)\n* For participants in Step 1 who are currently receiving an ampho B-based regimen or alternative treatment, completion of approximately 2 weeks of treatment. More information on this criterion can be found in the study protocol.\n* For participants in Step 2 who are currently receiving study-provided fluconazole and have no plans to discontinue study treatment, negative CSF culture after 2 weeks incubation from a sample obtained at or before Week 6 (Days 35-49).\n\nExclusion Criteria - Step 3\n\n* On study treatment beyond Week 10 (Day 77) in Step 1 or Step 2\n* Currently off study treatment\n\nInclusion Criteria - Step 4\n\n\\- On study treatment at Week 10 (Days 63-77) with no plans to discontinue study treatment\n\nExclusion Criteria - Step 4\n\n\\- Currently off study treatment'}, 'identificationModule': {'nctId': 'NCT00885703', 'briefTitle': 'High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis', 'orgStudyIdInfo': {'id': 'A5225 (HiFLAC)'}, 'secondaryIdInfos': [{'id': '10149', 'type': 'REGISTRY', 'domain': 'DAIDS-ES'}, {'id': 'ACTG A5225'}, {'id': 'HiFLAC'}, {'id': 'A5225/HiFLAC'}, {'id': 'A5225'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1, Fluconazole 1200mg', 'description': 'Participants receive Fluconazole 1200mg induction dose in Stage 1', 'interventionNames': ['Drug: Fluconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 1', 'interventionNames': ['Drug: Fluconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1, Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 1', 'interventionNames': ['Drug: Fluconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 1, Ampho B', 'description': 'Participants receive Amphotericin B followed by Fluconazole in Stage 1', 'interventionNames': ['Drug: Fluconazole', 'Drug: Amphotericin B']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2, Fluconazole 1600mg', 'description': 'Participants receive Fluconazole 1600mg induction dose in Stage 2', 'interventionNames': ['Drug: Fluconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2, Fluconazole 2000mg', 'description': 'Participants receive Fluconazole 2000mg induction dose in Stage 2', 'interventionNames': ['Drug: Fluconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2, Ampho B', 'description': 'Participants receive Amphotericin B followed by Fluconazole in Stage 2', 'interventionNames': ['Drug: Fluconazole', 'Drug: Amphotericin B']}], 'interventions': [{'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan'], 'description': 'Step 1: \\[For participants randomized to Fluconazole\\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).\n\nStep 2: \\[For participants randomized to Ampho B only\\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.\n\nStep 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.\n\nStep 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.', 'armGroupLabels': ['Stage 1, Ampho B', 'Stage 1, Fluconazole 1200mg', 'Stage 1, Fluconazole 1600mg', 'Stage 1, Fluconazole 2000mg', 'Stage 2, Ampho B', 'Stage 2, Fluconazole 1600mg', 'Stage 2, Fluconazole 2000mg']}, {'name': 'Amphotericin B', 'type': 'DRUG', 'otherNames': ['Amphotericin B deoxycholate', 'Ampho B', 'Amphocin', 'Fungizone', 'AmBisome', 'Abelecet', 'Amphotec'], 'description': "Step 1: \\[For participants randomized to Ampho B\\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight", 'armGroupLabels': ['Stage 1, Ampho B', 'Stage 2, Ampho B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033-1079', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Byramjee Jeejeebhoy Medical College (BJMC) CRS', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '20200', 'city': 'Kericho', 'state': 'Rift Valley', 'country': 'Kenya', 'facility': 'Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS', 'geoPoint': {'lat': -0.36774, 'lon': 35.28314}}, {'zip': '30100', 'city': 'Eldoret', 'country': 'Kenya', 'facility': 'Moi University Clinical Research Center (MUCRC) CRS', 'geoPoint': {'lat': 0.52036, 'lon': 35.26993}}, {'zip': '32', 'city': 'Lima', 'country': 'Peru', 'facility': 'San Miguel CRS', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '2092', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Wits Helen Joseph Hospital CRS (Wits HJH CRS)', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '4013', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Durban International Clinical Research Site CRS', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Parirenyatwa CRS', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Umesh G. Lalloo, MD, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Nelson R. Mandela School of Medicine'}, {'name': 'Robert A. Larsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'USC School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}