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Ignite Creation Date: 2025-12-25 @ 4:32 AM

Ignite Modification Date: 2026-03-02 @ 3:44 PM

Study NCT ID: NCT02489318

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-12-22

First Post: 2015-07-01

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C572045', 'term': 'apalutamide'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}], 'ancestors': [{'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Executive Medical Director', 'organization': 'Aragon Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 57 months', 'description': 'Safety Analysis set included all participants who received at least 1 dose of randomized study drug. Crossover participants were counted twice (in Placebo + ADT arm and in Placebo + ADT to Apalutamide + ADT arm) for safety analysis. For crossover participants, adverse events after initiation of crossover treatment were summarized separately in Placebo + ADT to Apalutamide + ADT arm. However, adverse events occurred before crossover treatment were summarized in Placebo + ADT arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.', 'otherNumAtRisk': 527, 'deathsNumAtRisk': 527, 'otherNumAffected': 485, 'seriousNumAtRisk': 527, 'deathsNumAffected': 35, 'seriousNumAffected': 115}, {'id': 'EG001', 'title': 'Placebo + ADT to Apalutamide + ADT', 'description': 'After interim analysis and unblinding, participants receiving placebo +ADT crossed over to receive 240 mg apalutamide orally qd along with ADT in open-label extension phase.', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 153, 'seriousNumAtRisk': 208, 'deathsNumAffected': 10, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.', 'otherNumAtRisk': 524, 'deathsNumAtRisk': 524, 'otherNumAffected': 494, 'seriousNumAtRisk': 524, 'deathsNumAffected': 31, 'seriousNumAffected': 153}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 68}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 23}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 47}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Lactate Dehydrogenase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Blood Thyroid Stimulating Hormone Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 55}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 47}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Vitamin D Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 101}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 106}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Groin Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 69}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pathological Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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527, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Urinary Tract Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Benign Prostatic Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Organising Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Paranasal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pleuritic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pneumothorax Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pulmonary Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pulmonary Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Venous Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 524, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiographic Progression-free Survival (rPFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'OG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.08', 'groupId': 'OG000', 'lowerLimit': '18.46', 'upperLimit': '32.92'}, {'value': 'NA', 'comment': 'Here NA signifies that the median, lower limit and upper limit of confidence interval (CI) were not estimable due to lesser number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.484', 'ciLowerLimit': '0.391', 'ciUpperLimit': '0.600', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 35 months', 'description': 'rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'OG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.17', 'comment': 'Here NA signifies that the upper limit of CI was not estimable due to lesser number of events.', 'groupId': 'OG000', 'lowerLimit': '41.86', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.651', 'ciLowerLimit': '0.534', 'ciUpperLimit': '0.793', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 57 months', 'description': 'OS was defined as the time from date of randomization to date of death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Time to Initiation of Cytotoxic Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'OG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.469', 'ciLowerLimit': '0.350', 'ciUpperLimit': '0.630', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 57 months', 'description': 'Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'OG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Here NA signifies that the median and upper limit of CI were not estimable due to lesser number of events.', 'groupId': 'OG000', 'lowerLimit': '51.32', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.868', 'ciLowerLimit': '0.700', 'ciUpperLimit': '1.076', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 57 months', 'description': 'Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Time to Chronic Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'OG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Here NA signifies that the median and upper limit of CI was not estimable due to lesser number of events.', 'groupId': 'OG000', 'lowerLimit': '51.32', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1563', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.794', 'ciLowerLimit': '0.576', 'ciUpperLimit': '1.094', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 57 months', 'description': 'Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (\\>=) 3 weeks for oral or \\>=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a \\>=30 percent (%) increase in total daily dose of the opioid analgesics lasting for \\>= 3 weeks for oral or \\>= 7 days for non-oral formulation.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Time to Skeletal-related Event (SRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'OG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Here NA signifies that the median and upper limit of CI were not estimable due to lesser number of events. .', 'groupId': 'OG000', 'lowerLimit': '51.78', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3608', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.857', 'ciLowerLimit': '0.615', 'ciUpperLimit': '1.194', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 57 months', 'description': 'Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'FG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}], 'periods': [{'title': 'Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '525'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '524'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Treated', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '524'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants crossed over from placebo to apalutamide after positive results at interim analysis.', 'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '319'}, {'groupId': 'FG001', 'numSubjects': '524'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Other: Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '267'}]}]}], 'preAssignmentDetails': 'Per protocol, 208 participants randomized to receive placebo+ADT were switched over to receive apalutamide+ADT after interim analysis and unblinding. Randomized treatment disposition has been reported in participant flow. Response/progression that occurred during a non-randomized switch-over to apalutamide+ADT were not counted towards efficacy outcome measures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '525', 'groupId': 'BG001'}, {'value': '1052', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Androgen Deprivation Therapy (ADT)', 'description': 'Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'BG001', 'title': 'Apalutamide + ADT', 'description': 'Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '8.42', 'groupId': 'BG000'}, {'value': '68.9', 'spread': '8.11', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '8.28', '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': '527', 'groupId': 'BG000'}, {'value': '525', 'groupId': 'BG001'}, {'value': '1052', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '231', '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': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '365', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '719', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'BRAZIL', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'CHINA', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'CZECH REPUBLIC', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'ISRAEL', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'JAPAN', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'SOUTH KOREA', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'TURKEY', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'UKRAINE', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '365', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '719', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-16', 'size': 1956104, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-06T08:33', 'hasProtocol': True}, {'date': '2019-01-10', 'size': 889548, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-06T08:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1052}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2015-07-01', 'resultsFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-12-17', 'studyFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Progression-free Survival (rPFS)', 'timeFrame': 'Up to 35 months', 'description': 'rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 57 months', 'description': 'OS was defined as the time from date of randomization to date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Time to Initiation of Cytotoxic Chemotherapy', 'timeFrame': 'Up to 57 months', 'description': 'Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.'}, {'measure': 'Time to Pain Progression', 'timeFrame': 'Up to 57 months', 'description': 'Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.'}, {'measure': 'Time to Chronic Opioid Use', 'timeFrame': 'Up to 57 months', 'description': 'Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (\\>=) 3 weeks for oral or \\>=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a \\>=30 percent (%) increase in total daily dose of the opioid analgesics lasting for \\>= 3 weeks for oral or \\>= 7 days for non-oral formulation.'}, {'measure': 'Time to Skeletal-related Event (SRE)', 'timeFrame': 'Up to 57 months', 'description': 'Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'JNJ-56021927', 'Androgen Deprivation Therapy', 'ARN-509', 'Apalutamide', 'TITAN', 'Metastatic Hormone-sensitive Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '39163505', 'type': 'DERIVED', 'citation': 'Karsh LI, Bevans KB, Saad F, Chung BH, Oudard S, Brookman-May SD, McCarthy SA, Smith MR, Chi KN, Small EJ, Agarwal N. Prostate-specific antigen and health-related quality of life in individuals with advanced prostate cancer treated with apalutamide: a plain language summary of the SPARTAN and TITAN studies. Future Oncol. 2024;20(35):2689-2698. doi: 10.1080/14796694.2024.2384257. Epub 2024 Aug 20.'}, {'pmid': '38940282', 'type': 'DERIVED', 'citation': 'Merseburger AS, Agarwal N, Bjartell A, Uemura H, Soto AJ, Bhaumik A, Bohm J, Tran N, Krochmann N, Nematian-Samani M, Mundle SD, Brookman-May SD, Lopez-Gitlitz A, McCarthy SA, Chi K, Chowdhury S. Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) study: ultralow prostate-specific antigen decline with apalutamide plus androgen-deprivation therapy. BJU Int. 2024 Dec;134(6):982-991. doi: 10.1111/bju.16449. Epub 2024 Jun 28.'}, {'pmid': '37951974', 'type': 'DERIVED', 'citation': 'Shen J, Chowdhury S, Agarwal N, Karsh LI, Oudard S, Gartrell BA, Feyerabend S, Saad F, Pieczonka CM, Chi KN, Brookman-May SD, Rooney B, Bhaumik A, McCarthy SA, Bevans KB, Mundle SD, Small EJ, Smith MR, Graff JN. Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN. Br J Cancer. 2024 Jan;130(1):73-81. doi: 10.1038/s41416-023-02492-8. Epub 2023 Nov 11.'}, {'pmid': '37708629', 'type': 'DERIVED', 'citation': 'Merseburger AS, Agarwal N, Bhaumik A, Lefresne F, Karsh LI, Pereira de Santana Gomes AJ, Soto AJ, Given RW, Brookman-May SD, Mundle SD, McCarthy SA, Uemura H, Chowdhury S, Chi KN, Bjartell A. Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study. Eur J Cancer. 2023 Nov;193:113290. doi: 10.1016/j.ejca.2023.113290. Epub 2023 Aug 11.'}, {'pmid': '34039013', 'type': 'DERIVED', 'citation': 'Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Basch E, Miladinovic B, Lopez-Gitlitz A, Chi KN. Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study. J Urol. 2021 Oct;206(4):914-923. doi: 10.1097/JU.0000000000001841. Epub 2021 May 27.'}, {'pmid': '33914595', 'type': 'DERIVED', 'citation': 'Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29.'}, {'pmid': '32878613', 'type': 'DERIVED', 'citation': 'Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0.'}, {'pmid': '31578173', 'type': 'DERIVED', 'citation': 'Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29.'}, {'pmid': '31150574', 'type': 'DERIVED', 'citation': 'Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez Soto A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.', 'detailedDescription': "This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multinational, multicenter study of apalutamide in participants with mHSPC. The study consists of 4 Phases: Screening Phase (up to 28 days before randomization), Treatment Phase (28 day treatment cycles until disease progression or the occurrence of unacceptable treatment related toxicity), an End of Treatment Phase (until 30 days after the last dose of study drug), and then a Survival Follow up Phase. In the event of a positive study result and notification of unblinding at either of the interim analyses or at the final analysis, participants in the treatment Phase will have the opportunity to enroll in an Open-label Extension Phase, which will allow participants to receive active drug (apalutamide) for approximately 3 years. Participants who are receiving apalutamide in the Open-label Extension Phase may continue receiving apalutamide in the Long-term Extension (LTE) Phase if they will continue to derive benefit from treatment (based on investigator assessment). Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of prostate adenocarcinoma as confirmed by the investigator\n* Metastatic disease documented by greater than or equal to (\\>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1\n* Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel \\<=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization\n* Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (\\<=) 6 months of ADT prior to randomization\n* Allowed prior treatments for localized prostate cancer (all treatments must have been completed \\>= 1 year prior to randomization) a) \\<= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies\n\nExclusion Criteria:\n\n* Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate\n* Known brain metastases\n* Lymph nodes as only sites of metastases\n* Visceral (ie, liver or lung) metastases as only sites of metastases\n* Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer\n* Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer\n* History of seizures or medications known to lower seizure threshold'}, 'identificationModule': {'nctId': 'NCT02489318', 'acronym': 'TITAN', 'briefTitle': 'A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aragon Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)', 'orgStudyIdInfo': {'id': 'CR107614'}, 'secondaryIdInfos': [{'id': '56021927PCR3002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2015-000735-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apalutamide plus ADT', 'description': 'Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.', 'interventionNames': ['Drug: Apalutamide', 'Drug: Androgen Deprivation Therapy (ADT)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo plus ADT', 'description': 'Participants will receive matching Placebo with ADT.', 'interventionNames': ['Drug: Placebo', 'Drug: Androgen Deprivation Therapy (ADT)']}], 'interventions': [{'name': 'Apalutamide', 'type': 'DRUG', 'otherNames': ['JNJ-56021927', 'ARN-509'], 'description': 'Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.', 'armGroupLabels': ['Apalutamide plus ADT']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive Placebo orally once daily in each 28 day treatment cycles.', 'armGroupLabels': ['Placebo plus ADT']}, {'name': 'Androgen Deprivation Therapy (ADT)', 'type': 'DRUG', 'description': 'All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.', 'armGroupLabels': ['Apalutamide plus ADT', 'Placebo plus ADT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United 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