Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-29 @ 3:58 AM
Study NCT ID:
NCT03518034
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2018-05-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
Sponsor:
Organization:
Raw JSON
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Non-serious adverse events (AEs): from first dose of study drug to 30 days post last dose (up to Month 48). All-cause mortality (ACM): entire study duration (up to approximately 52 months).', 'description': 'Other AEs were not collected prior to first dose, per protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'AndroGel 1.62% Predose', 'description': 'Participants randomized to the AndroGel 1.62% arm, prior to first dose.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 2601, 'otherNumAffected': 0, 'seriousNumAtRisk': 2601, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Placebo Predose', 'description': 'Participants randomized to the Placebo arm, prior to first dose.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 2603, 'otherNumAffected': 0, 'seriousNumAtRisk': 2603, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.', 'otherNumAtRisk': 2601, 'deathsNumAtRisk': 2601, 'otherNumAffected': 160, 'seriousNumAtRisk': 2601, 'deathsNumAffected': 144, 'seriousNumAffected': 585}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.', 'otherNumAtRisk': 2603, 'deathsNumAtRisk': 2603, 'otherNumAffected': 170, 'seriousNumAtRisk': 2603, 'deathsNumAffected': 148, 'seriousNumAffected': 562}], 'otherEvents': [{'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2596, 'numEvents': 169, 'numAffected': 160}, {'groupId': 'EG003', 'numAtRisk': 2602, 'numEvents': 183, 'numAffected': 170}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'BLOOD LOSS ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'IRON DEFICIENCY ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'LEUKOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'POLYCYTHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ACUTE LEFT VENTRICULAR FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 35, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'AORTIC VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 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'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 40, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 35, 'numAffected': 30}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ATRIAL TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ATRIOVENTRICULAR BLOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 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'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'CARDIOGENIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'CARDIOPULMONARY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'CARDIOVASCULAR DISORDER', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'AORTIC STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ARTERIAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ARTERIAL THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ARTERIOSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HYPERTENSIVE EMERGENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HYPERTENSIVE URGENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ILIAC ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'INTERMITTENT CLAUDICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'MALIGNANT HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL ARTERY ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL ARTERY THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'PERIPHERAL VENOUS DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'SHOCK HAEMORRHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'SUBCLAVIAN VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'VASCULAR COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'VASCULAR STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'VENOUS THROMBOSIS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2603, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2601, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2603, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months)', 'description': 'MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'PRIMARY', 'title': 'Time From Randomization to the First Component Event of MACE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% confidence interval (CI) could not be calculated due to an insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% confidence interval (CI) could not be calculated due to an insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.17', 'estimateComment': 'HR of AndroGel to placebo and 95% CI were estimated from Cox proportional-hazards regression model, with adjustment for pre-existing CVD.', 'groupDescription': "The hazard ratio (HR) and 2-sided 95% confidence interval (CI) were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing cardiovascular disease (CVD) status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of MACE. If a subject does not experience a MACE during the study, the time is right-censored at the time of participant's last available follow-up observation.", 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority margin in terms of HR is 1.5.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months)', 'description': 'MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to the First Component Event of CV Safety Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to an insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to an insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.21', 'estimateComment': 'HR of AndroGel to placebo and 2-sided 95% CI were estimated from a Cox proportional-hazards regression model with adjustment of pre-existing CVD status.', 'groupDescription': "The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of CV safety endpoint. If a participant does not experience a CV safety endpoint during the study, the time is right-censored at the time of participant's last available follow-up observation.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'SECONDARY', 'title': 'Incidence of High-Grade Prostate Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.39', 'ciUpperLimit': '6.77', 'estimateComment': 'Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior cardiovascular disease (CVD).', 'groupDescription': 'The high grade prostate cancer endpoint was analyzed using a discrete time proportional hazard regression model with event time intervals based on scheduled visits, and adjusting for pre-existing CVD status. The HR of AndroGel to Placebo and its 2-sided 95% CI were provided.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.24'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.75'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '1.23'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.76'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '1.28'}, {'value': '0.46', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.82'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is derived from the omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using linear mixed regression model.', 'groupDescription': 'A linear mixed regression model was used to analyze the change in PDQ-Q4 from baseline to months 6, 12, and 24, with the dependent variable being the change in PDQ-Q4 score. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CVD status. An unstructured covariance matrix was used to account for correlations among repeated measures within-subject.', 'statisticalMethod': 'linear mixed regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Omnibus likelihood-ratio chi-square test from linear mixed regression model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.79', 'estimateComment': 'LS mean difference (AndroGel - Placebo) at month 6 was derived from linear mixed regression model.', 'groupDescription': 'Month 6 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.83', 'estimateComment': 'LS mean difference (AndroGel - Placebo) at month 12 was derived from linear mixed regression model.', 'groupDescription': 'Month 12 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.96', 'estimateComment': 'LS mean difference (AndroGel - Placebo) at month 24 was derived from linear mixed regression model.', 'groupDescription': 'Month 24 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Months 6, 12, and 24', 'description': 'PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Sexual Function Sub-Study: participants in the TRAVERSE main study full analysis set (i.e., randomized, no duplicate/triplicate participant IDs) who were eligible for the sexual function sub-study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '0.96', 'ciUpperLimit': '3.86', 'groupDescription': 'Month 6 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.64', 'ciUpperLimit': '3.63', 'groupDescription': 'Month 12 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.94', 'groupDescription': 'Month 24 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.197', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The omnibus test p value is a test of the null hypothesis of no difference between AndroGel and placebo groups across all time points.', 'groupDescription': 'Risk ratio of remission of LG-PDD in the TRT versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.', 'statisticalMethod': 'GEE Poisson regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 12, 24', 'description': 'The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score \\<5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PDD Sub-Study participants (those included TRAVERSE main study full analysis set participants \\[i.e., randomized, no duplicate/triplicate participant IDs\\] who met the criteria for low-grade PDD) with an assessment at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2601', 'groupId': 'OG000'}, {'value': '2603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time From Randomization to First Clinical Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2601', 'groupId': 'OG000'}, {'value': '2603', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to an insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI could not be calculated due to an insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.97', 'estimateComment': 'Cox proportional-hazards model.', 'groupDescription': "The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a subject is defined as the time from randomization to the first occurrence of a clinical fracture. If a subject does not experience a clinic fracture during the study, the follow-up time is right-censored at the time of subject's last available follow-up observation.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to event or maximum follow-up (up to approximately 52 months).', 'description': 'Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.', 'groupDescription': 'Repeated measures log-binomial regression with effects for treatment, visit, treatment-by-visit interaction, and adjusted for pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.', 'statisticalMethod': 'omnibus likelihood-ratio chi-square test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 24, 36 and 48', 'description': 'The correction of anemia was defined as an increase in hemoglobin level \\>12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in TRAVERSE main study who had anemia at baseline; participants with an assessment at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '575', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.494', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.', 'groupDescription': 'The risk ratio of progression to diabetes in the AndroGel versus placebo group was estimated by a repeated measures log-binomial regression with fixed effects for treatment, visit, treatment-visit interaction, and pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.', 'statisticalMethod': 'Repeated measures log-binomial regr.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 24, 36 and 48', 'description': 'Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels \\>125 mg/dL, assessed at all available time points after baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in TRAVERSE main study who had prediabetes at baseline; participants with an assessment at given time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.23', 'estimateComment': 'Cox proportional-hazards model adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no date (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who died, regardless of cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.62', 'estimateComment': 'Cox proportional-hazards model adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no date (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.32', 'estimateComment': 'Cox proportional-hazards model adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no date (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.51', 'estimateComment': 'Cox proportional-hazards model adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Prostate Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.55', 'ciUpperLimit': '2.31', 'estimateComment': 'Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who underwent prostate biopsy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Prostate Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.47', 'ciUpperLimit': '2.42', 'estimateComment': 'Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Acute Urinary Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.65', 'ciUpperLimit': '2.41', 'estimateComment': 'Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.54', 'estimateComment': 'Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '0.95', 'ciUpperLimit': '3.84', 'estimateComment': 'Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Participants in Full Analysis Set (randomized, and no duplicate/triplicate participant IDs)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2601'}, {'groupId': 'FG001', 'numSubjects': '2603'}]}, {'type': 'Participants in Safety Analysis Set (Randomized, Treated, no Duplicate/Triplicate Participant IDs)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2596'}, {'groupId': 'FG001', 'numSubjects': '2602'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1594'}, {'groupId': 'FG001', 'numSubjects': '1581'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1007'}, {'groupId': 'FG001', 'numSubjects': '1022'}]}], 'dropWithdraws': [{'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '351'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '446'}, {'groupId': 'FG001', 'numSubjects': '458'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COVID-19 Logistical Restriction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Serum Testosterone Level >750 ng/dL', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other, Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Reason Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited in the study across 316 sites in the US and Puerto Rico.', 'preAssignmentDetails': 'Of the 5246 participants randomized in the study, 42 participant identification numbers (IDs; AndroGel: 22 IDs; Placebo: 20 IDs) were randomized to 20 unique participants and these 42 duplicate/triplicate IDs were excluded from the Full Analysis Set. Additionally, a total of 6 randomized participants (AndroGel: 5 participants; Placebo: 1 participant) did not receive treatment and were excluded from the from the Safety Analysis Set, which resulted in 5198 participants in the Safety Analysis Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'BG000'}, {'value': '2602', 'groupId': 'BG001'}, {'value': '5198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AndroGel 1.62%', 'description': 'Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received matching placebo OD.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '7.93', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '7.85', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '7.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2596', 'groupId': 'BG000'}, {'value': '2602', 'groupId': 'BG001'}, {'value': '5198', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '409', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '848', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2186', 'groupId': 'BG000'}, {'value': '2161', 'groupId': 'BG001'}, {'value': '4347', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '445', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '877', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2066', 'groupId': 'BG000'}, {'value': '2083', 'groupId': 'BG001'}, {'value': '4149', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'TRAVERSE Main Study Safety Set: All participants randomized with no duplicates who received at least one dose of study drug, grouped according to actual treatment received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-06', 'size': 3294772, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-05T09:46', 'hasProtocol': True}, {'date': '2023-01-01', 'size': 2804421, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-05T09:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2018-05-03', 'resultsFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-14', 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24', 'timeFrame': 'From Baseline to Months 6, 12, and 24', 'description': 'PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.'}, {'measure': 'Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition', 'timeFrame': 'Months 6, 12, 24', 'description': 'The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score \\<5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome.'}, {'measure': 'Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded.'}, {'measure': 'Time From Randomization to First Clinical Fracture', 'timeFrame': 'Randomization to event or maximum follow-up (up to approximately 52 months).', 'description': 'Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded.'}, {'measure': 'Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period', 'timeFrame': 'Baseline, Months 6, 12, 24, 36 and 48', 'description': 'The correction of anemia was defined as an increase in hemoglobin level \\>12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline.'}, {'measure': 'Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48', 'timeFrame': 'Baseline, Months 6, 12, 24, 36 and 48', 'description': 'Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels \\>125 mg/dL, assessed at all available time points after baseline.'}, {'measure': 'Tertiary Endpoint: Incidence Rate of All Cause Mortality', 'timeFrame': 'Randomization to event or last known date if no date (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who died, regardless of cause.'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Heart Failure', 'timeFrame': 'Randomization to event or last known date if no date (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC.'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events', 'timeFrame': 'Randomization to event or last known date if no date (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC.'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Prostate Biopsy', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who underwent prostate biopsy.'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Prostate Cancer', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC).'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Acute Urinary Retention', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC.'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms.'}, {'measure': 'Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure.'}], 'primaryOutcomes': [{'measure': 'Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months)', 'description': 'MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).'}, {'measure': 'Time From Randomization to the First Component Event of MACE', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months)', 'description': 'MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.'}], 'secondaryOutcomes': [{'measure': 'Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.'}, {'measure': 'Time From Randomization to the First Component Event of CV Safety Endpoint', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC.'}, {'measure': 'Incidence of High-Grade Prostate Cancer', 'timeFrame': 'Randomization to event or last known date if no event (up to approximately 52 months).', 'description': 'Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypogonadism', 'cardiovascular (CV) disease', 'AndroGel', 'testosterone replacement therapy (TRT)'], 'conditions': ['Hypogonadism', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '40246046', 'type': 'DERIVED', 'citation': 'Gagliano-Juca T, Pencina KM, Shang YV, Travison TG, Lincoff AM, Nissen SE, Artz AS, Li X, Chan A, Patel R, Miller MG, Bhasin S. Association of testosterone-induced increase in neutrophil and monocyte counts with thromboembolic events: The TRAVERSE trial. Am Heart J. 2025 Oct;288:77-88. doi: 10.1016/j.ahj.2025.04.004. Epub 2025 Apr 15.'}, {'pmid': '38315466', 'type': 'DERIVED', 'citation': 'Bhasin S, Lincoff AM, Nissen SE, Wannemuehler K, McDonnell ME, Peters AL, Khan N, Snabes MC, Li X, Li G, Buhr K, Pencina KM, Travison TG. Effect of Testosterone on Progression From Prediabetes to Diabetes in Men With Hypogonadism: A Substudy of the TRAVERSE Randomized Clinical Trial. JAMA Intern Med. 2024 Apr 1;184(4):353-362. doi: 10.1001/jamainternmed.2023.7862.'}, {'pmid': '38231621', 'type': 'DERIVED', 'citation': 'Snyder PJ, Bauer DC, Ellenberg SS, Cauley JA, Buhr KA, Bhasin S, Miller MG, Khan NS, Li X, Nissen SE. Testosterone Treatment and Fractures in Men with Hypogonadism. N Engl J Med. 2024 Jan 18;390(3):203-211. doi: 10.1056/NEJMoa2308836.'}, {'pmid': '38150256', 'type': 'DERIVED', 'citation': "Bhasin S, Travison TG, Pencina KM, O'Leary M, Cunningham GR, Lincoff AM, Nissen SE, Lucia MS, Preston MA, Khera M, Khan N, Snabes MC, Li X, Tangen CM, Buhr KA, Thompson IM Jr. Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2348692. doi: 10.1001/jamanetworkopen.2023.48692."}, {'pmid': '37889486', 'type': 'DERIVED', 'citation': 'Pencina KM, Travison TG, Artz AS, Lincoff AM, Nissen SE, Flevaris P, Chan A, Li X, Diegel SA, Wannemuehler K, Bhasin S. Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340030. doi: 10.1001/jamanetworkopen.2023.40030.'}, {'pmid': '37326322', 'type': 'DERIVED', 'citation': 'Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, Cunningham GR, Granger CB, Khera M, Thompson IM Jr, Wang Q, Wolski K, Davey D, Kalahasti V, Khan N, Miller MG, Snabes MC, Chan A, Dubcenco E, Li X, Yi T, Huang B, Pencina KM, Travison TG, Nissen SE; TRAVERSE Study Investigators. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023 Jul 13;389(2):107-117. doi: 10.1056/NEJMoa2215025. Epub 2023 Jun 16.'}], 'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men between 45 and 80 years age\n* Participants with low serum testosterone concentrations (\\< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.\n\nExclusion Criteria:\n\n* Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate\n* Participants with prostate specific antigen (PSA) \\> 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)\n* Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated\n* Confirmed testosterone \\< 100 ng/dL\n* Body Mass Index (BMI) \\> 50\n* Hemoglobin A1c (HbA1C) \\> 11%\n* Hematocrit (Hct) \\> 50%\n* Estimated Glomerular Filtration Rate (eGFR) \\< 30 ml/min\n* History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).'}, 'identificationModule': {'nctId': 'NCT03518034', 'acronym': 'TRAVERSE', 'briefTitle': 'A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study', 'orgStudyIdInfo': {'id': 'M16-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AndroGel 1.62%', 'description': 'Participants receive topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may receive a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations are necessary.', 'interventionNames': ['Drug: AndroGel®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive matching placebo OD.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AndroGel®', 'type': 'DRUG', 'description': 'testosterone administered topically', 'armGroupLabels': ['AndroGel 1.62%']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo administered topically', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35007-8978', 'city': 'Alabaster', 'state': 'Alabama', 'country': 'United States', 'facility': 'Wright Clinical Research, LLC /ID# 210864', 'geoPoint': {'lat': 33.24428, 'lon': -86.81638}}, {'zip': '35211-1320', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Simon-Williamson Clinic /ID# 210249', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235-3430', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics /ID# 202982', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Research, Inc. /ID# 167928', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Alabama', 'country': 'United States', 'facility': 'Atlanta VAHCS /ID# 170318', 'geoPoint': {'lat': 34.60593, 'lon': -86.98334}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'G & L Research, LLC /ID# 170365', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '36542', 'city': 'Gulf Shores', 'state': 'Alabama', 'country': 'United States', 'facility': 'Fundamental Research /ID# 170504', 'geoPoint': {'lat': 30.24604, 'lon': -87.70082}}, {'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Centers of Alabama /ID# 206197', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Longwood Research /ID# 201754', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center, Inc. /ID# 170569', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608-6705', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mostellar Medical Center /ID# 170329', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35674-1773', 'city': 'Tuscumbia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Terence T. Hart, MD /ID# 201561', 'geoPoint': {'lat': 34.7312, 'lon': -87.70253}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Urological Institute /ID# 167894', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85224-6278', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus Clinical Research US, INC /ID# 170530', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85268-3791', 'city': 'Fountain Hills', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fountain Hills Family Practice P.C /ID# 170419', 'geoPoint': {'lat': 33.61171, 'lon': -111.71736}}, {'zip': '85295', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Horizon Clinical Research Asoc /ID# 202937', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85308-5125', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Lenzmeier Family Medicine /ID# 202945', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus - Desert Clinical Research /ID# 170428', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Medical Group, PC /ID# 170516', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Health Care System /ID# 167968', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies, LLC /ID# 168058', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Family Practice Specialists /ID# 167859', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Central Phoenix Medical Clinic /ID# 170333', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tatum Highlands Medical Assoc /ID# 208277', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85283-1527', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fiel Family & Sports Medicine /ID# 203034', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85712-2142', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Assoc /ID# 170421', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85712-2822', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Quality of Life Medical & Research Center /ID# 167915', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southern Arizona VA Health Care System /ID# 167600', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724-0001', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Verde Valley Medical Center /ID# 202955', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Eclipse Clinical Research /ID# 170381', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'B.G. 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