Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-04-13 @ 9:44 AM
Study NCT ID:
NCT03085095
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561634', 'term': 'relugolix'}, {'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials@Myovant.com', 'phone': '650-278-8743', 'title': 'Clinical Trials at Myovant', 'organization': 'Myovant Sciences GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 (after dosing) through up to 52 weeks', 'description': 'All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.', 'otherNumAtRisk': 622, 'deathsNumAtRisk': 622, 'otherNumAffected': 493, 'seriousNumAtRisk': 622, 'deathsNumAffected': 7, 'seriousNumAffected': 76}, {'id': 'EG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection.', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 239, 'seriousNumAtRisk': 308, 'deathsNumAffected': 9, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 20}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 338}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 159}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 36}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Hypercalcaemia of malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Abdominal incarcerated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pulmonary contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Brachial plexus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Cystitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 622, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sustained Castration Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '97.9'}, {'value': '88.8', 'groupId': 'OG001', 'lowerLimit': '84.6', 'upperLimit': '91.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.9', 'ciLowerLimit': '4.1', 'ciUpperLimit': '11.8', 'estimateComment': 'Treatment difference= Relugolix - Leuprolide acetate', 'groupDescription': 'Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided type I error of 0.05.', 'nonInferiorityComment': 'If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.'}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)', 'description': 'Sustained castration rate defined as the cumulative probability of testosterone suppression to \\< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.\n\nThe lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Castration Rate At Week 1 Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.04', 'groupId': 'OG000', 'lowerLimit': '52.18', 'upperLimit': '59.97'}, {'value': '0.00', 'comment': 'Not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significance was met if p-value \\< 0.05.', 'groupDescription': 'Alpha-protected statistical analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided type I error rate of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 Day 4 (Day 4)', 'description': 'Castration rate was defined as the cumulative probability of testosterone suppression to \\< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Castration Rate At Week 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.71', 'groupId': 'OG000', 'lowerLimit': '97.56', 'upperLimit': '99.39'}, {'value': '12.05', 'groupId': 'OG001', 'lowerLimit': '8.88', 'upperLimit': '16.25'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significance was met if p-value \\< 0.05.', 'groupDescription': 'Alpha-protected statistical analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided type I error rate of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3 Day 1 (Day 15)', 'description': 'Castration rate was defined as the cumulative probability of testosterone suppression to \\< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Confirmed Prostate-specific Antigen (PSA) Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '76.03', 'upperLimit': '82.53'}, {'value': '19.8', 'groupId': 'OG001', 'lowerLimit': '15.50', 'upperLimit': '24.70'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significance was met if p-value \\< 0.05.', 'groupDescription': 'Alpha-protected statistical analysis.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)', 'description': 'Confirmed PSA response defined as \\> 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Profound Castration Rate At Week 3 Day 1 (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.38', 'groupId': 'OG000', 'lowerLimit': '75.06', 'upperLimit': '81.53'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '3.00'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.41', 'ciLowerLimit': '73.98', 'ciUpperLimit': '80.83', 'pValueComment': 'Statistically significance was met if p-value \\< 0.05.', 'estimateComment': 'Treatment difference= Relugolix - Leuprolide acetate', 'groupDescription': 'Alpha-protected statistical analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided type I error rate of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3 Day 1 (Day 15)', 'description': 'Castration rate defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Follicle-stimulating Hormone (FSH) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.72', 'spread': '1.376', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '3.071', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significance was met if p-value \\< 0.05.', 'groupDescription': 'Alpha-protected statistical analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided type I error rate of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 25 Day 1 (Day 169)', 'description': 'To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'PSA Response Rate At Week 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '76.70', 'upperLimit': '83.14'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '15.80', 'upperLimit': '25.05'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3 Day 1 (Day 15)', 'description': 'PSA response defined as \\> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'PSA Response Rate At Week 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '92.44', 'upperLimit': '96.19'}, {'value': '79.2', 'groupId': 'OG001', 'lowerLimit': '74.26', 'upperLimit': '83.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 Day 1 (Day 29)', 'description': 'PSA response defined as \\> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Testosterone Recovery Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': '≥ 50 ng/dL', 'categories': [{'measurements': [{'value': '93.01', 'groupId': 'OG000', 'lowerLimit': '87.82', 'upperLimit': '96.54'}, {'value': '10.12', 'groupId': 'OG001', 'lowerLimit': '3.84', 'upperLimit': '25.24'}]}]}, {'title': '> 280 ng/dL', 'categories': [{'measurements': [{'value': '53.93', 'groupId': 'OG000', 'lowerLimit': '45.20', 'upperLimit': '63.16'}, {'value': '3.23', 'groupId': 'OG001', 'lowerLimit': '0.46', 'upperLimit': '20.77'}]}]}, {'title': '> Baseline level or 280 ng/dL', 'categories': [{'measurements': [{'value': '54.73', 'groupId': 'OG000', 'lowerLimit': '45.97', 'upperLimit': '63.94'}, {'value': '3.23', 'groupId': 'OG001', 'lowerLimit': '0.46', 'upperLimit': '20.77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90 follow-up', 'description': 'The cumulative probability of testosterone recovery back to \\> 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to \\> 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and were followed in the testosterone recovery phase.'}, {'type': 'SECONDARY', 'title': 'Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '84.5'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '73.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '6.9', 'ciUpperLimit': '19.1', 'estimateComment': 'Treatment difference= Relugolix - Leuprolide acetate', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)', 'description': 'Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Profound Castration Rate At Week 1 Day 4 (Day 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.92', 'groupId': 'OG000', 'lowerLimit': '5.18', 'upperLimit': '9.22'}, {'value': '0.0', 'comment': 'Not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 1 Day 4 (Day 4)', 'description': 'Castration rate defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '87.3'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '90.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '2.0', 'estimateComment': 'Treatment difference= Relugolix - Leuprolide acetate', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)', 'description': 'Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Undetectable PSA Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '17.62', 'upperLimit': '24.14'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '16.39', 'upperLimit': '25.74'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 25 Day 1 (Day 169)', 'description': 'Defined as the proportion of participants with PSA concentration \\< 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Rate Of PSA Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.31', 'groupId': 'OG000', 'lowerLimit': '86.52', 'upperLimit': '91.55'}, {'value': '89.50', 'groupId': 'OG001', 'lowerLimit': '85.39', 'upperLimit': '92.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 49 Day 1 (Day 337)', 'description': 'PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '18.13', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '15.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': 'The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': 'Physical functioning', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '13.09', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '12.29', 'groupId': 'OG001'}]}]}, {'title': 'Role functioning', 'categories': [{'measurements': [{'value': '-6.2', 'spread': '19.92', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '17.84', 'groupId': 'OG001'}]}]}, {'title': 'Emotional functioning', 'categories': [{'measurements': [{'value': '0.5', 'spread': '16.12', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '13.23', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive functioning', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '16.77', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '16.37', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '18.31', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '18.18', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '6.1', 'spread': '19.46', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '18.40', 'groupId': 'OG001'}]}]}, {'title': 'Nausea and vomiting', 'categories': [{'measurements': [{'value': '0.2', 'spread': '7.12', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.02', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '1.7', 'spread': '20.19', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '21.96', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '5.3', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '20.25', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '4.8', 'spread': '25.88', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '21.82', 'groupId': 'OG001'}]}]}, {'title': 'Appetite loss', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '17.82', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '14.86', 'groupId': 'OG001'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '1.4', 'spread': '23.26', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '18.88', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '2.0', 'spread': '16.70', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '19.60', 'groupId': 'OG001'}]}]}, {'title': 'Financial difficulties', 'categories': [{'measurements': [{'value': '0.2', 'spread': '18.28', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '19.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': 'The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '537', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': 'Sexual activity', 'categories': [{'measurements': [{'value': '13.9', 'spread': '26.51', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '27.90', 'groupId': 'OG001'}]}]}, {'title': 'Sexual functioning', 'categories': [{'measurements': [{'value': '-9.0', 'spread': '23.37', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '21.10', 'groupId': 'OG001'}]}]}, {'title': 'Hormonal treatment-related symptoms', 'categories': [{'measurements': [{'value': '10.6', 'spread': '12.25', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '13.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': "Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '537', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': 'Urinary symptoms', 'categories': [{'measurements': [{'value': '1.1', 'spread': '15.29', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '13.78', 'groupId': 'OG001'}]}]}, {'title': 'Incontinence aid use', 'categories': [{'measurements': [{'value': '1.0', 'spread': '15.41', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.80', 'groupId': 'OG001'}]}]}, {'title': 'Bowel symptoms', 'categories': [{'measurements': [{'value': '1.2', 'spread': '8.92', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '9.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': "Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '14.36', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '14.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': 'The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': 'Week 1 Day 4 (Day 4)', 'categories': [{'measurements': [{'value': '-88.25', 'spread': '20.696', 'groupId': 'OG000'}, {'value': '147.71', 'spread': '122.735', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 Day 1 (Day 29)', 'categories': [{'measurements': [{'value': '-94.54', 'spread': '8.500', 'groupId': 'OG000'}, {'value': '-82.67', 'spread': '27.146', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 Day 1 (Day 169)', 'categories': [{'measurements': [{'value': '-93.93', 'spread': '7.242', 'groupId': 'OG000'}, {'value': '-93.45', 'spread': '13.202', 'groupId': 'OG001'}]}]}, {'title': 'Week 49 Day 1 (Day 337)', 'categories': [{'measurements': [{'value': '-91.54', 'spread': '16.779', 'groupId': 'OG000'}, {'value': '-95.14', 'spread': '4.507', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline In Serum Concentrations Of FSH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': 'Week 1 Day 4 (Day 4)', 'categories': [{'measurements': [{'value': '-62.59', 'spread': '9.051', 'groupId': 'OG000'}, {'value': '-4.74', 'spread': '36.121', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 Day 1 (Day 29)', 'categories': [{'measurements': [{'value': '-90.80', 'spread': '8.151', 'groupId': 'OG000'}, {'value': '-67.73', 'spread': '27.311', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 Day 1 (Day 169)', 'categories': [{'measurements': [{'value': '-86.32', 'spread': '10.699', 'groupId': 'OG000'}, {'value': '-47.53', 'spread': '32.560', 'groupId': 'OG001'}]}]}, {'title': 'Week 49 Day 1 (Day 337)', 'categories': [{'measurements': [{'value': '-79.39', 'spread': '21.987', 'groupId': 'OG000'}, {'value': '-47.23', 'spread': '30.112', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline In Serum Concentrations Of Dihydrotestosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': 'Week 5 Day 1 (Day 29)', 'categories': [{'measurements': [{'value': '-87.61', 'spread': '12.225', 'groupId': 'OG000'}, {'value': '-81.95', 'spread': '23.733', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 Day 1 (Day 169)', 'categories': [{'measurements': [{'value': '-88.06', 'spread': '11.810', 'groupId': 'OG000'}, {'value': '-85.45', 'spread': '32.261', 'groupId': 'OG001'}]}]}, {'title': 'Week 49 Day 1 (Day 337)', 'categories': [{'measurements': [{'value': '-88.23', 'spread': '11.235', 'groupId': 'OG000'}, {'value': '-87.56', 'spread': '12.088', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline In Serum Concentrations Of Sex Hormone-Binding Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'title': 'Week 5 Day 1 (Day 29)', 'categories': [{'measurements': [{'value': '1.08', 'spread': '22.068', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '20.430', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 Day 1 (Day 169)', 'categories': [{'measurements': [{'value': '7.24', 'spread': '28.265', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '24.947', 'groupId': 'OG001'}]}]}, {'title': 'Week 49 Day 1 (Day 337)', 'categories': [{'measurements': [{'value': '6.54', 'spread': '28.787', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '27.051', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) Of Relugolix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Single-Dose', 'description': 'Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Relugolix Repeat-Dose', 'description': 'Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '220', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2', 'description': 'The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of Japanese participants enrolled in study were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Single-Dose', 'description': 'Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Relugolix Repeat-Dose', 'description': 'Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '663', 'spread': '151', 'groupId': 'OG000'}, {'value': '373', 'spread': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2', 'description': 'The AUC0-τ of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.', 'unitOfMeasure': 'ng⸳hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of Japanese participants enrolled in study were included in the PK analysis.'}, {'type': 'SECONDARY', 'title': 'Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Single-Dose', 'description': 'Relugolix oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Relugolix Repeat-Dose', 'description': 'Relugolix 120-mg tablet administered orally once daily for 2 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.400', 'upperLimit': '4.05'}, {'value': '0.983', 'groupId': 'OG001', 'lowerLimit': '0.433', 'upperLimit': '4.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2', 'description': 'The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of Japanese participants enrolled in study were included in the PK analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'OG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)', 'description': 'MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Relugolix', 'description': 'Relugolix 120-milligram (mg) tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'FG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '624'}, {'groupId': 'FG001', 'numSubjects': '310'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'comment': 'Four participants (2 in each treatment group) were randomized but did not receive study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '622'}, {'groupId': 'FG001', 'numSubjects': '308'}]}, {'type': 'COMPLETED', 'comment': 'Completed 48 weeks of treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '563'}, {'groupId': 'FG001', 'numSubjects': '276'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Testosterone Suppression Level Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Did not Receive Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Dosing Interruption (Logistical Reason)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'To support registration in China, the study continued to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 90 participants.', 'preAssignmentDetails': 'The primary analysis of efficacy and safety included 934 participants. The primary analysis excluded additional participants with metastatic disease and a cohort of participants enrolled in China and Taiwan who will be included in the final analysis of the study (N=200).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '622', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '930', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Relugolix', 'description': 'Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.'}, {'id': 'BG001', 'title': 'Leuprolide Acetate', 'description': 'Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '7.75', 'groupId': 'BG000'}, {'value': '71.0', 'spread': '8.03', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '7.84', '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': '622', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '930', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '558', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '827', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '434', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '636', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-23', 'size': 7886722, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-01T16:06', 'hasProtocol': True}, {'date': '2019-11-07', 'size': 4164491, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-27T16:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'dispFirstSubmitDate': '2020-10-05', 'completionDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2017-03-09', 'dispFirstSubmitQcDate': '2021-03-02', 'resultsFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2017-03-14', 'dispFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-02', 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)', 'timeFrame': 'From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)', 'description': 'MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause.'}], 'primaryOutcomes': [{'measure': 'Sustained Castration Rate', 'timeFrame': 'From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)', 'description': 'Sustained castration rate defined as the cumulative probability of testosterone suppression to \\< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.\n\nThe lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.'}], 'secondaryOutcomes': [{'measure': 'Castration Rate At Week 1 Day 4', 'timeFrame': 'Week 1 Day 4 (Day 4)', 'description': 'Castration rate was defined as the cumulative probability of testosterone suppression to \\< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Castration Rate At Week 3 Day 1', 'timeFrame': 'Week 3 Day 1 (Day 15)', 'description': 'Castration rate was defined as the cumulative probability of testosterone suppression to \\< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Confirmed Prostate-specific Antigen (PSA) Response Rate', 'timeFrame': 'Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)', 'description': 'Confirmed PSA response defined as \\> 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1.'}, {'measure': 'Profound Castration Rate At Week 3 Day 1 (Day 15)', 'timeFrame': 'Week 3 Day 1 (Day 15)', 'description': 'Castration rate defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Follicle-stimulating Hormone (FSH) Level', 'timeFrame': 'Week 25 Day 1 (Day 169)', 'description': 'To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.'}, {'measure': 'PSA Response Rate At Week 3 Day 1', 'timeFrame': 'Week 3 Day 1 (Day 15)', 'description': 'PSA response defined as \\> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'PSA Response Rate At Week 5 Day 1', 'timeFrame': 'Week 5 Day 1 (Day 29)', 'description': 'PSA response defined as \\> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Testosterone Recovery Rate', 'timeFrame': 'Day 90 follow-up', 'description': 'The cumulative probability of testosterone recovery back to \\> 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to \\> 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1', 'timeFrame': 'Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)', 'description': 'Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Profound Castration Rate At Week 1 Day 4 (Day 4)', 'timeFrame': 'At Week 1 Day 4 (Day 4)', 'description': 'Castration rate defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1', 'timeFrame': 'Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)', 'description': 'Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \\< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Undetectable PSA Rate', 'timeFrame': 'Week 25 Day 1 (Day 169)', 'description': 'Defined as the proportion of participants with PSA concentration \\< 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Rate Of PSA Progression-free Survival', 'timeFrame': 'Week 49 Day 1 (Day 337)', 'description': 'PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants.'}, {'measure': 'Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': 'The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).'}, {'measure': 'Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': 'The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).'}, {'measure': 'Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': "Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems)."}, {'measure': 'Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': "Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems)."}, {'measure': 'Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L)', 'timeFrame': 'Baseline, Week 49 Day 1 (Day 337)', 'description': 'The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement.'}, {'measure': 'Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone', 'timeFrame': 'Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.'}, {'measure': 'Percent Change From Baseline In Serum Concentrations Of FSH', 'timeFrame': 'Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.'}, {'measure': 'Percent Change From Baseline In Serum Concentrations Of Dihydrotestosterone', 'timeFrame': 'Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.'}, {'measure': 'Percent Change From Baseline In Serum Concentrations Of Sex Hormone-Binding Globulin', 'timeFrame': 'Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)', 'description': 'Blood samples were collected from participants for hormonal measurements.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) Of Relugolix', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2', 'description': 'The Cmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose pharmacokinetics (PK) was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.'}, {'measure': 'Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2', 'description': 'The AUC0-τ of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.'}, {'measure': 'Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix', 'timeFrame': 'Predose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 and Week 2', 'description': 'The Tmax of relugolix was determined for single and repeat doses in subsets of participants from Japan. Single dose PK was assessed on Day 1 following an initial 360 mg dose of relugolix. Repeat dose PK was assessed following repeat dosing of relugolix 120 mg once daily for 2 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '32469183', 'type': 'BACKGROUND', 'citation': 'Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B; HERO Study Investigators. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187-2196. doi: 10.1056/NEJMoa2004325. Epub 2020 May 29.'}, {'pmid': '37713020', 'type': 'DERIVED', 'citation': 'Shore ND, Mehlhaff BA, Cookson MS, Saltzstein DR, Tutrone R, Brown B, Lu S, Fallick M, Hanson S, Saad F. Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer. Adv Ther. 2023 Nov;40(11):4919-4927. doi: 10.1007/s12325-023-02634-7. Epub 2023 Sep 15.'}, {'pmid': '35587650', 'type': 'DERIVED', 'citation': 'Shore ND, Sutton J. Plain language summary of the HERO study comparing relugolix with leuprolide for men with advanced prostate cancer. Future Oncol. 2022 Jul;18(21):2575-2584. doi: 10.2217/fon-2022-0172. Epub 2022 May 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\\< 50 nanograms/deciliter \\[ng/dL\\]) in participants with androgen-sensitive advanced prostate cancer.', 'detailedDescription': 'This is a phase 3, multinational, randomized, open-label, parallel group study to evaluate the efficacy and safety of oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year of continuous androgen-deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan based on local labels), every 3 months by subcutaneous injection will be administered to participants.\n\nThere are 2 analyses for this study, a primary analysis and a final analysis.\n\nPrimary Analysis:\n\nThe primary analysis of efficacy and safety has been completed (N=934). Participants were randomized 2:1 to receive relugolix or leuprolide for 48 weeks, followed by a 30-day safety follow-up visit or early termination 30-day safety follow-up.\n\nFinal Analysis:\n\nThe final analysis will occur after additional participants with metastatic disease (approximately 130) have been enrolled and randomized from any sites to the study, and have completed the 48-week treatment period. A cohort of participants enrolled in China and Taiwan will be analyzed separately once they have completed treatment to support registration in China.\n\nEligible participants were randomized 2:1 to relugolix or leuprolide arm and will attend visits monthly (every 4 weeks) where serum testosterone and prostate-specific antigen will be assessed. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms.\n\nCastration resistance-free survival will be assessed up to Week 49, Day 1 of the study and reported as part of the final analysis.\n\nThe study enrolled 1134 participants, including 139 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of castration resistance-free survival and 93 Chinese participants (enrolled in China and Taiwan) to support registration in China.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.\n2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations:\n\n 1. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery; or\n 2. Newly diagnosed androgen-sensitive metastatic disease; or\n 3. Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent.\n3. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles \\[nmol\\]/liter \\[L\\]).\n4. Has a serum PSA concentration at the Screening visit of \\> 2.0 ng/milliliter (mL) (2.0 microgram \\[μg\\]/L), or, when applicable, post radical prostatectomy of \\> 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound \\> 2.0 ng/mL (2.0 μg/L) above the post interventional nadir.\n5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.\n\nKey Exclusion Criteria:\n\n1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy.\n2. Previously received gonadotropin-releasing hormone analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for \\> 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot.\n3. Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen).\n4. Metastases to brain per prior clinical evaluation.\n5. Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months.\n6. Active conduction system abnormalities.\n7. Uncontrolled hypertension."}, 'identificationModule': {'nctId': 'NCT03085095', 'acronym': 'HERO', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myovant Sciences GmbH'}, 'officialTitle': 'HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer', 'orgStudyIdInfo': {'id': 'MVT-601-3201'}, 'secondaryIdInfos': [{'id': '2017-000160-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relugolix', 'description': 'Relugolix for 48 weeks', 'interventionNames': ['Drug: Relugolix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leuprolide Acetate', 'description': 'Leuprolide acetate for 48 weeks', 'interventionNames': ['Drug: Leuprolide Acetate']}], 'interventions': [{'name': 'Relugolix', 'type': 'DRUG', 'otherNames': 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