Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-27 @ 9:28 AM
Study NCT ID:
NCT01193257
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571806', 'term': 'orteronel'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days (Cycle 59 Day 58) after the last dose of study drug.', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.', 'otherNumAtRisk': 363, 'otherNumAffected': 341, 'seriousNumAtRisk': 363, 'seriousNumAffected': 148}, {'id': 'EG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.', 'otherNumAtRisk': 732, 'otherNumAffected': 703, 'seriousNumAtRisk': 732, 'seriousNumAffected': 384}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 103}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 319}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 272}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 222}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 201}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 223}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 77}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 113}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 113}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 101}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 208}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 45}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 139}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 112}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 89}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 110}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 86}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 57}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 76}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 78}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 67}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 67}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 63}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 84}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 63}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abscess oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '13.48', 'upperLimit': '16.86'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '15.45', 'upperLimit': '18.67'}]}]}], 'analyses': [{'pValue': '0.12085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.875', 'ciLowerLimit': '0.739', 'ciUpperLimit': '1.036', 'groupDescription': "Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\\[less than or equal to\\] \\<=4, greater than \\[\\>\\] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until death (approximately up to 4.5 years)', 'description': 'Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Radiographic Progression-free Survival (rPFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.46', 'upperLimit': '6.97'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '7.76', 'upperLimit': '8.48'}]}]}], 'analyses': [{'pValue': '0.00038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.760', 'ciLowerLimit': '0.653', 'ciUpperLimit': '0.885', 'groupDescription': "Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\\<=4, \\>4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '24.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'P-values test for odds ratio equal to 1.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '12.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12778', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'P-values test for odds ratio equal to 1.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (\\>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '732', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '732', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs Related to Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '732', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs Related to Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '732', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Weight increased', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'title': 'Baseline: 0; Overall: 0', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 0; Overall: 1', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 0; Overall: 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 0; Overall: 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 0; Overall: 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 1; Overall: 0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 1; Overall: 1', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 1; Overall: 2', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 1; Overall: 3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 1; Overall: 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2; Overall: 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2; Overall: 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2; Overall: 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2; Overall: 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58)', 'description': "ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\\>50% of waking hours \\[hrs\\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \\>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '732', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 59 Day 58', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '732', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'title': 'Digestive enzymes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Renal function analyses', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Liver function analyses', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Tissue enzyme analyses NEC', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Coagulation and bleeding analyses', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Mineral and electrolyte analyses', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell analyses', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Carbohydrate tolerance analyses-including diabetes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urinary tract function analyses NEC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Platelet analyses', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol analyses', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell analyses', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Protein analyses not elsewhere classified (NEC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Vascular tests NEC (including blood pressure)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal cortex tests', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism tests NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Skeletal and cardiac muscle analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urinalysis NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving PSA50 Response at Any Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'title': 'Cycle 4 (n= 283; 559)', 'categories': [{'measurements': [{'value': '12.72', 'groupId': 'OG000'}, {'value': '32.74', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 (n= 163; 403)', 'categories': [{'measurements': [{'value': '18.40', 'groupId': 'OG000'}, {'value': '38.21', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 (n= 102; 267)', 'categories': [{'measurements': [{'value': '22.55', 'groupId': 'OG000'}, {'value': '36.70', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13 (n= 55; 171)', 'categories': [{'measurements': [{'value': '23.64', 'groupId': 'OG000'}, {'value': '40.94', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 (n= 34; 107)', 'categories': [{'measurements': [{'value': '23.53', 'groupId': 'OG000'}, {'value': '44.86', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19 (n= 24; 68)', 'categories': [{'measurements': [{'value': '20.83', 'groupId': 'OG000'}, {'value': '42.65', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 (n= 14; 36)', 'categories': [{'measurements': [{'value': '28.57', 'groupId': 'OG000'}, {'value': '52.78', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 (n= 8; 16)', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000'}, {'value': '62.50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle: 4, 7, 10, 13, 16, 19, 22, and 25', 'description': 'The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000'}, {'value': '9.66', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving PSA90 Response at Any Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'title': 'Cycle 7 (n=163; 403)', 'categories': [{'measurements': [{'value': '4.91', 'groupId': 'OG000'}, {'value': '14.89', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 (n=102; 267)', 'categories': [{'measurements': [{'value': '6.86', 'groupId': 'OG000'}, {'value': '14.23', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13 (n=55; 171)', 'categories': [{'measurements': [{'value': '7.27', 'groupId': 'OG000'}, {'value': '15.20', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 (n=34; 107)', 'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000'}, {'value': '19.63', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19 (n=24; 68)', 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000'}, {'value': '23.53', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 (n=14; 36)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '27.78', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 (n=8; 16)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '43.75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle: 7, 10, 13, 16, 19, 22, and 25', 'description': 'The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Best PSA Response at Any Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'timeFrame': 'Cycle: 4, 7, 10, 13, 16, 19, 22, and 25', 'description': 'The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'Best PSA response was not evaluated due to change in planned analysis.'}, {'type': 'SECONDARY', 'title': 'Time to PSA Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '2.90'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.40', 'upperLimit': '5.56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.5 years)', 'description': 'Time to PSA progression was defined as time from randomization to a PSA increase of 25% and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, above the baseline PSA.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'title': 'Baseline: Favorable; EOT: Favorable', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Favorable; EOT: Unfavorable', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Unfavorable; EOT: Favorable', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Unfavorable; EOT: Unfavorable', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and EOT (Cycle 59 Day 58)', 'description': 'A favorable CTC count was defined as less than (\\<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as \\>=5 counts/7.5 mL in whole blood.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population where baseline and post-baseline assessments were available. ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (CR) was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response per RECIST-evaluable population was defined as a subset of participants who had measurable disease by RECIST 1.1 at baseline.'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'comment': 'The upper limit was not estimable.', 'groupId': 'OG000', 'lowerLimit': '20.48', 'upperLimit': 'NA'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '18.24', 'upperLimit': '24.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)', 'description': 'Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was \\>= 4 with a \\>= 2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was \\>= 4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was \\<= 3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Pain Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median: No data is reported since median time to pain response was not estimable (that is, not reached) in either treatment group due to low number of events. Confidence interval: Confidence interval was not estimable due to low number of events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median: No data is reported since median time to pain response was not estimable (that is, not reached) in either treatment group due to low number of events. Confidence interval: Confidence interval was not estimable due to low number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'Time to pain response was defined as the time from randomization until first pain response. Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A \\>= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Pain Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'Best pain response was evaluated in participants who had a pain response across the entire study were summarized by treatment group. The pain response was defined as a \\>=2-point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'OG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The global health status or quality of life (QOL) was measured as the HRQOL response rate at 12 weeks using the 2-item global health status index of the european organization for research and treatment of cancer-quality of life questionnaire-C30 (EORTC QLQ-C30) instrument. HRQOL response was defined as a 17-point increase from the baseline assessment on the QOL index, after the score had been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional, and social), 1 global health status, 3 symptom scales (fatigue, pain, nausea/vomiting) and 6 single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score representing better level of functioning or greater degree of symptoms.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'FG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '734'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}, {'groupId': 'FG001', 'numSubjects': '732'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '734'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '391'}]}, {'type': 'Study termination by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Unblinded due to futility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '251'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 260 investigative sites in North America, Europe, Argentina, Australia, Brazil, Chile, China, Colombia, Israel, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, and Taiwan from 15 November 2010 to 29 February 2016.', 'preAssignmentDetails': 'Male participants with a historical diagnosis of metastatic-castration resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy were enrolled in 1 of 2 treatment groups: Orteronel 400 mg + Prednisone 5 mg or Placebo + Prednisone 5 mg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '734', 'groupId': 'BG001'}, {'value': '1099', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Prednisone', 'description': 'Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'BG001', 'title': 'Orteronel + Prednisone', 'description': 'Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.4', 'spread': '7.95', 'groupId': 'BG000'}, {'value': '69.2', 'spread': '7.82', 'groupId': 'BG001'}, {'value': '69.3', 'spread': '7.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '365', 'groupId': 'BG000'}, {'value': '734', 'groupId': 'BG001'}, {'value': '1099', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '890', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '620', 'groupId': 'BG001'}, {'value': '925', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Belarus', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan, Province Of China', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic Of', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.33', 'spread': '7.675', 'groupId': 'BG000'}, {'value': '172.52', 'spread': '7.156', 'groupId': 'BG001'}, {'value': '172.12', 'spread': '7.350', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Height data was available for 1096 participants as follows: n= 364, 732.', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.85', 'spread': '15.183', 'groupId': 'BG000'}, {'value': '82.77', 'spread': '15.200', 'groupId': 'BG001'}, {'value': '81.80', 'spread': '15.249', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Weight data was available for 1098 participants as follows: n= 365, 733.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.14', 'spread': '4.491', 'groupId': 'BG000'}, {'value': '27.73', 'spread': '4.370', 'groupId': 'BG001'}, {'value': '27.54', 'spread': '4.418', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI data was available for 1095 participants as follows: n= 364, 731.', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) population included all subjects who were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1099}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'dispFirstSubmitDate': '2016-03-04', 'completionDateStruct': {'date': '2016-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2010-08-31', 'dispFirstSubmitQcDate': '2016-03-04', 'resultsFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2010-08-31', 'dispFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-28', 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Baseline until death (approximately up to 4.5 years)', 'description': 'Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.'}], 'secondaryOutcomes': [{'measure': 'Radiographic Progression-free Survival (rPFS)', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria.'}, {'measure': 'Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12', 'timeFrame': 'Week 12', 'description': 'The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline.'}, {'measure': 'Percentage of Participants With Pain Response at Week 12', 'timeFrame': 'Week 12', 'description': 'Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (\\>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.'}, {'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)'}, {'measure': 'Number of Participants With Abnormal Physical Examination Findings', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)'}, {'measure': 'Number of Participants With TEAEs Related to Vital Signs', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)'}, {'measure': 'Number of Participants With TEAEs Related to Weight', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)'}, {'measure': 'Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status', 'timeFrame': 'Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58)', 'description': "ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\\>50% of waking hours \\[hrs\\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \\>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period."}, {'measure': 'Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings', 'timeFrame': 'Cycle 59 Day 58'}, {'measure': 'Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel', 'timeFrame': 'Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)'}, {'measure': 'Percentage of Participants Achieving PSA50 Response at Any Time During the Study', 'timeFrame': 'Cycle: 4, 7, 10, 13, 16, 19, 22, and 25', 'description': 'The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline.'}, {'measure': 'Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12', 'timeFrame': 'Week 12', 'description': 'The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.'}, {'measure': 'Percentage of Participants Achieving PSA90 Response at Any Time During the Study', 'timeFrame': 'Cycle: 7, 10, 13, 16, 19, 22, and 25', 'description': 'The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.'}, {'measure': 'Best PSA Response at Any Time During the Study', 'timeFrame': 'Cycle: 4, 7, 10, 13, 16, 19, 22, and 25', 'description': 'The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline.'}, {'measure': 'Time to PSA Progression', 'timeFrame': 'Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.5 years)', 'description': 'Time to PSA progression was defined as time from randomization to a PSA increase of 25% and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, above the baseline PSA.'}, {'measure': 'Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)', 'timeFrame': 'Baseline and EOT (Cycle 59 Day 58)', 'description': 'A favorable CTC count was defined as less than (\\<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as \\>=5 counts/7.5 mL in whole blood.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (CR) was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \\<10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes.'}, {'measure': 'Time to Pain Progression', 'timeFrame': 'Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)', 'description': 'Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was \\>= 4 with a \\>= 2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was \\>= 4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was \\<= 3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use.'}, {'measure': 'Time to Pain Response', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'Time to pain response was defined as the time from randomization until first pain response. Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A \\>= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method.'}, {'measure': 'Number of Participants With Best Pain Response', 'timeFrame': 'Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)', 'description': 'Best pain response was evaluated in participants who had a pain response across the entire study were summarized by treatment group. The pain response was defined as a \\>=2-point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline.'}, {'measure': 'Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12', 'timeFrame': 'Week 12', 'description': "The global health status or quality of life (QOL) was measured as the HRQOL response rate at 12 weeks using the 2-item global health status index of the european organization for research and treatment of cancer-quality of life questionnaire-C30 (EORTC QLQ-C30) instrument. HRQOL response was defined as a 17-point increase from the baseline assessment on the QOL index, after the score had been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional, and social), 1 global health status, 3 symptom scales (fatigue, pain, nausea/vomiting) and 6 single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score representing better level of functioning or greater degree of symptoms."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '29272162', 'type': 'DERIVED', 'citation': 'Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.'}, {'pmid': '26031410', 'type': 'DERIVED', 'citation': 'Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.'}, {'pmid': '25624429', 'type': 'DERIVED', 'citation': 'Fizazi K, Jones R, Oudard S, Efstathiou E, Saad F, de Wit R, De Bono J, Cruz FM, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak DP, Lee SY, Webb IJ, Tejura B, Borgstein N, Dreicer R. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol. 2015 Mar 1;33(7):723-31. doi: 10.1200/JCO.2014.56.5119. Epub 2015 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEach participant must meet all of the following inclusion criteria:\n\n* Voluntary written consent\n* Male 18 years or older\n* Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma\n* Radiograph-documented metastatic disease\n* Progressive disease\n* Prior surgical castration or concurrent use of an agent for medical castration\n* Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (\\>=) 360 milligram per square meter (mg/m\\^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving \\>= 360 mg/m\\^2 are also eligible if they have received at least 225 mg/m\\^2 of docetaxel within a 6-month period and meet the other study entry criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse\n* Screening laboratory values as specified in protocol\n* Stable medical condition\n* Life expectancy of 6 months or more\n* Participants who have had up to 2 prior chemotherapy treatments are eligible to participate\n\nExclusion Criteria:\n\nParticipants meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n* Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue\n* Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone\n* Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug\n* Radioisotope therapy or external beam radiation therapy within 4 weeks of first dose of study drug\n* Documented central nervous system metastases\n* Treatment with any investigational compound within 30 days prior to first dose of study drug (Participants who are in long-term follow-up following active treatment in other trials are eligible)\n* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected\n* Uncontrolled cardiovascular condition as specified in study protocol\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C\n* Unwilling or unable to comply with protocol\n* Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel\n* Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy\n* Prostate cancer confined to just the prostrate bed or immediate adjacent tissue'}, 'identificationModule': {'nctId': 'NCT01193257', 'briefTitle': 'Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.', 'orgStudyIdInfo': {'id': 'C21005'}, 'secondaryIdInfos': [{'id': '2010-018662-23', 'type': 'EUDRACT_NUMBER'}, {'id': 'CTR20131423', 'type': 'REGISTRY', 'domain': 'SFDA CTR'}, {'id': '0991413212', 'type': 'REGISTRY', 'domain': 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