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Ignite Creation Date: 2025-12-25 @ 3:45 AM

Ignite Modification Date: 2026-03-03 @ 4:27 AM

Study NCT ID: NCT02799602

Status: COMPLETED

Last Update Posted: 2025-12-04

First Post: 2016-06-06

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607739', 'term': 'darolutamide'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer AG'}, 'certainAgreement': {'otherDetails': 'Bayer may recommend any changes to the Publication as deemed necessary for scientific purposes. If the Publication could hinder the ability to obtain patent protection for any Invention, Bayer may request a delay of the Publication for a reasonable period to be able to file the patent application, but not to exceed 6 months from the date publication is received for review. Bayer may request further delay in case the patent application has been filed and the priority application is incomplete.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug administration until 30 days after the last administration, including adverse event of all-cause mortality at any time during the study, up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)', 'description': 'Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.\n\nEvents causally related to treatment were considered as events causally related to either darolutamide / Docetaxel or Placebo / Docetaxel\n\nA total of 1305 patients were randomized for efficacy analysis, however 1302 patients only started treatment and were included to safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \\<=12 weeks before randomization.', 'otherNumAtRisk': 652, 'deathsNumAtRisk': 652, 'otherNumAffected': 636, 'seriousNumAtRisk': 652, 'deathsNumAffected': 231, 'seriousNumAffected': 306}, {'id': 'EG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \\<=12 weeks before randomization.', 'otherNumAtRisk': 650, 'deathsNumAtRisk': 650, 'otherNumAffected': 634, 'seriousNumAtRisk': 650, 'deathsNumAffected': 305, 'seriousNumAffected': 276}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 276, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 227, 'numAffected': 164}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 108, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 103, 'numAffected': 67}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 40, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 47, 'numAffected': 43}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 40, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 202, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 162, 'numAffected': 132}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 229, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 225, 'numAffected': 157}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 150, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 174, 'numAffected': 134}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 87, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 69, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 63, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 69, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 89, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 83, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 291, 'numAffected': 222}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 287, 'numAffected': 215}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 78, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 97, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 206, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 194, 'numAffected': 169}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 48, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 104, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 110, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 69, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 56, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 73, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 52, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 91, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 92, 'numAffected': 63}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 64, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 37, 'numAffected': 33}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 132, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 103, 'numAffected': 81}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 120, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 84, 'numAffected': 66}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 432, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 415, 'numAffected': 151}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 147, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 130, 'numAffected': 105}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 395, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 360, 'numAffected': 142}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 53, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 53, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 100, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 74, 'numAffected': 61}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 157, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 96, 'numAffected': 86}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 270, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 249, 'numAffected': 173}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 154, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 147, 'numAffected': 121}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 91, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 96, 'numAffected': 82}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 59, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 54, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 103, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 84, 'numAffected': 65}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 148, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 95, 'numAffected': 78}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 69, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 64, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 88, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 84, 'numAffected': 80}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 72, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 58, 'numAffected': 49}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 44, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 40, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 91, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 72, 'numAffected': 68}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 45, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 66, 'numAffected': 55}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 74, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 72, 'numAffected': 68}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 85, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 93, 'numAffected': 80}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 73, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 43, 'numAffected': 36}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 47, 'numAffected': 43}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 103, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 83, 'numAffected': 73}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 73, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 78, 'numAffected': 71}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 50, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 268, 'numAffected': 267}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 265, 'numAffected': 264}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 54, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nail discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 51, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 52, 'numAffected': 52}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 54, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 62, 'numAffected': 52}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 64, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 58, 'numAffected': 45}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 112, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 72, 'numAffected': 61}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 141, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 136, 'numAffected': 122}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 44, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Myelosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 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'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Loss of personal independence in daily activities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Orchidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Spinal laminectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bilateral orchidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Spinal fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Radical prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cancer surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrial appendage closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Product contamination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Device deposit issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 650, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'OS From Date of Randomization Until Death From Any Cause - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number of patients with event', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients censored', 'categories': [{'measurements': [{'value': '422', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.675', 'ciLowerLimit': '0.568', 'ciUpperLimit': '0.801', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)', 'description': 'Overall survival (OS) was defined as the time from the date of randomization until death from any cause.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nLong-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '649', 'groupId': 'OG000'}, {'value': '643', 'groupId': 'OG001'}]}]}, {'title': 'TESAE', 'categories': [{'measurements': [{'value': '306', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to study drug dose modification', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to permanent discontinuation of study drug', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to docetaxel dose modification', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to permanent discontinuation of docetaxel', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Related to protocol-required procedure', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Any study drug-related TEAE', 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}]}, {'title': 'Study drug-related TESAE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Study drug-related TEAE leading to study drug dose modification', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Study drug-related TEAE leading to permanent discontinuation of study drug', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)', 'description': 'TEAEs = Treatment-emergent adverse events, were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients who started treatment is presented based on the randomized treatment assignment. One patient was randomized to the placebo+docetaxel arm but received at least one dose of darolutamide. This patient was included in the darolutamide+docetaxel arm in the analysis of all safety variables.'}, {'type': 'SECONDARY', 'title': 'Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number of patients with event', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients censored', 'categories': [{'measurements': [{'value': '426', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Castration-Resistant Prostate Cancer (CRPC) - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '21.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.357', 'ciLowerLimit': '0.302', 'ciUpperLimit': '0.421', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number of patients with event', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients censored', 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': 'NA'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '36.1'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.792', 'ciLowerLimit': '0.660', 'ciUpperLimit': '0.950', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number of patients with event', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients censored', 'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptomatic Skeletal Event Free Survival (SSE-FS) - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': 'NA'}, {'value': '39.7', 'groupId': 'OG001', 'lowerLimit': '36.0', 'upperLimit': '42.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.609', 'ciLowerLimit': '0.516', 'ciUpperLimit': '0.718', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Symptomatic Skeletal Event (SSE) - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number (%) of patients with event', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Number (%) of patients censored', 'categories': [{'measurements': [{'value': '556', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Symptomatic Skeletal Event (SSE) - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.712', 'ciLowerLimit': '0.539', 'ciUpperLimit': '0.940', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number (%) of patients with event', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}]}, {'title': 'Number (%) of patients censored', 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Initiation of Subsequent Antineoplastic Therapy - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '28.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.388', 'ciLowerLimit': '0.328', 'ciUpperLimit': '0.458', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Worsening of Disease-Related Physical Symptoms - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number (%) of patients with event', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}]}, {'title': 'Number (%) of patients censored', 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Worsening of Disease-Related Physical Symptoms - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '24.8'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '27.6'}]}]}], 'analyses': [{'pValue': '0.7073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.043', 'ciLowerLimit': '0.894', 'ciUpperLimit': '1.217', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Initiation of Opioid Use for ≥7 Consecutive Days - Number of Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'title': 'Number of patients with event', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients censored', 'categories': [{'measurements': [{'value': '559', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization of the first participant to the first opioid use for ≥7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Initiation of Opioid Use for ≥7 Consecutive Days - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.688', 'ciLowerLimit': '0.523', 'ciUpperLimit': '0.906', 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio \\< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).', 'otherAnalysisDescription': 'One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\\<ULN vs. \\>=ULN).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant to the first opioid use for ≥7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'OS From Date of Randomization Until Death From Any Cause - Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'OG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '48.9', 'comment': 'NA = Value cannot be estimated due to censored data', 'groupId': 'OG001', 'lowerLimit': '44.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)', 'description': 'Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nLong-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.\n\nMedian, percentile and other 95% CIs were computed using Kaplan-Meier estimates.\n\nNA = Value cannot be estimated due to censored data', 'unitOfMeasure': 'Month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'FG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized: 1306 patients were randomized. One patient was excluded from analysis due to a GCP violation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '651'}, {'groupId': 'FG001', 'numSubjects': '654'}]}, {'type': 'Started Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '651'}, {'groupId': 'FG001', 'numSubjects': '651'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing with treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '651'}, {'groupId': 'FG001', 'numSubjects': '654'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Additional primary malignancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Adverse event associated with clinical disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Progressive disease - clinical progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '276'}]}, {'type': 'Progressive disease - radiological progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'Adverse event not associated with clinical disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'Study drug never administered', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This multinational study was conducted between 30-Nov-2016 First Participant First Visit and 11-Apr-2023 Last Participant Last Visit, in 23 countries/regions:\n\nAustralia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russian Federation, South Korea, Spain, Sweden, Taiwan, UK, US', 'preAssignmentDetails': '1306 were randomly assigned in a 1:1 ratio to study treatment and 1305 were considered valid for efficacy analyses. A total of 1302 participants started treatment and were included to safety analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Darolutamide (BAY1841788) + Docetaxel', 'description': 'Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).\n\nDocetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'BG001', 'title': 'Placebo + Docetaxel', 'description': 'Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.\n\nADT administration started ≤12 weeks before randomization.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '408', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '828', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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': '651', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1305', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '561', 'groupId': 'BG000'}, {'value': '557', 'groupId': 'BG001'}, {'value': '1118', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', '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': '231', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '476', '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': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'More than one race includes: "American Indian or Alaska Native", "Native Hawaiian or other Pacific Islander", and "Multiple"', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-26', 'size': 1388344, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-24T23:00', 'hasProtocol': True}, {'date': '2021-11-11', 'size': 5467954, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-24T23:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2016-06-06', 'resultsFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-01-29', 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS From Date of Randomization Until Death From Any Cause - Number of Events', 'timeFrame': 'From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)', 'description': 'Overall survival (OS) was defined as the time from the date of randomization until death from any cause.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nLong-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.'}, {'measure': 'OS From Date of Randomization Until Death From Any Cause - Month', 'timeFrame': 'From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)', 'description': 'Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nLong-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.\n\nMedian, percentile and other 95% CIs were computed using Kaplan-Meier estimates.\n\nNA = Value cannot be estimated due to censored data'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With TEAEs', 'timeFrame': 'From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)', 'description': 'TEAEs = Treatment-emergent adverse events, were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.'}, {'measure': 'Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events', 'timeFrame': 'From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Time to Castration-Resistant Prostate Cancer (CRPC) - Month', 'timeFrame': 'From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data'}, {'measure': 'Time to Pain Progression - Number of Events', 'timeFrame': 'From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Time to Pain Progression - Month', 'timeFrame': 'From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data'}, {'measure': 'Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Symptomatic Skeletal Event Free Survival (SSE-FS) - Month', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data'}, {'measure': 'Time to First Symptomatic Skeletal Event (SSE) - Number of Events', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Time to First Symptomatic Skeletal Event (SSE) - Month', 'timeFrame': 'From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data'}, {'measure': 'Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events', 'timeFrame': 'From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Time to Initiation of Subsequent Antineoplastic Therapy - Month', 'timeFrame': 'From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data'}, {'measure': 'Time to Worsening of Disease-Related Physical Symptoms - Number of Events', 'timeFrame': 'From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Time to Worsening of Disease-Related Physical Symptoms - Month', 'timeFrame': 'From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire.\n\nTreatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Time to Initiation of Opioid Use for ≥7 Consecutive Days - Number of Events', 'timeFrame': 'From randomization of the first participant to the first opioid use for ≥7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.'}, {'measure': 'Time to Initiation of Opioid Use for ≥7 Consecutive Days - Month', 'timeFrame': 'From randomization of the first participant to the first opioid use for ≥7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 months', 'description': 'Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded.\n\nTreatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance.\n\nActive follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.\n\nNA = Value cannot be estimated due to censored data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Hormone-sensitive Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '36795843', 'type': 'DERIVED', 'citation': 'Hussain M, Tombal B, Saad F, Fizazi K, Sternberg CN, Crawford ED, Shore N, Kopyltsov E, Kalebasty AR, Bogemann M, Ye D, Cruz F, Suzuki H, Kapur S, Srinivasan S, Verholen F, Kuss I, Joensuu H, Smith MR. Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial. J Clin Oncol. 2023 Jul 10;41(20):3595-3607. doi: 10.1200/JCO.23.00041. Epub 2023 Feb 16.'}, {'pmid': '35656777', 'type': 'DERIVED', 'citation': 'Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford D, Manarite J, Muslin D, Farrington T, Tombal B. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial. Future Oncol. 2022 Jul;18(21):2585-2597. doi: 10.2217/fon-2022-0433. Epub 2022 Jun 3.'}, {'pmid': '35179323', 'type': 'DERIVED', 'citation': 'Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/study/17777', 'label': "Click here to find further information and, after study completion, the study results according to Bayer's transparency standards"}, {'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization.\n\nThe subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel.\n\nTreatment with darolutamide (ODM-201)/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the investigator or his/her designated associate(s), death, non-compliance, or if sponsor terminates the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of prostate.\n* Metastatic disease\n* Candidates for ADT and docetaxel.\n* Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate bone marrow, liver and renal function\n\nExclusion Criteria:\n\n* Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.\n* Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.\n* Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)\n* Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease-free\n* Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.\n* Inability to swallow oral medications'}, 'identificationModule': {'nctId': 'NCT02799602', 'acronym': 'ARASENS', 'briefTitle': 'Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer', 'orgStudyIdInfo': {'id': '17777'}, 'secondaryIdInfos': [{'id': '2015-002590-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel', 'description': 'Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel', 'interventionNames': ['Drug: BAY1841788 / darolutamide (ODM-201)', 'Drug: Standard ADT (androgen deprivation therapy)', 'Drug: Docetaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + standard ADT + Docetaxel', 'description': 'Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel', 'interventionNames': ['Drug: Standard ADT (androgen deprivation therapy)', 'Drug: Docetaxel', 'Drug: Placebo']}], 'interventions': [{'name': 'BAY1841788 / darolutamide (ODM-201)', 'type': 'DRUG', 'description': '600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel', 'armGroupLabels': ['BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel']}, {'name': 'Standard ADT (androgen deprivation therapy)', 'type': 'DRUG', 'description': 'As prescribed by the treating physician.', 'armGroupLabels': ['BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel', 'Placebo + standard ADT + Docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'As prescribed by the treating physician.', 'armGroupLabels': ['BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel', 'Placebo + standard ADT + Docetaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone \\[LHRH\\] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.', 'armGroupLabels': ['Placebo + standard ADT + Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, 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Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}