Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT00510718
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2007-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'C540278', 'term': 'enzalutamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.', 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.', 'otherNumAtRisk': 28, 'otherNumAffected': 27, 'seriousNumAtRisk': 28, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.', 'otherNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.', 'otherNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.', 'otherNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period', 'description': 'All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.', 'otherNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Nodal rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Intestinal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Coronary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG007', 'title': 'MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period', 'description': 'All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)', 'description': 'An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to first 35 days of the study treatment in multiple dose period', 'description': "DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) : All Participants', 'description': 'Participants received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to first 35 days of the study treatment in multiple dose period', 'description': 'Tolerability was defined as if less than (\\<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and \\< 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if \\<8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.', 'unitOfMeasure': 'milligrams per day', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.43', 'spread': '11.80', 'groupId': 'OG000'}, {'value': '15.64', 'spread': '3.50', 'groupId': 'OG001'}, {'value': '38.21', 'spread': '23.64', 'groupId': 'OG002'}, {'value': '58.39', 'spread': '47.64', 'groupId': 'OG003'}, {'value': '79.26', 'spread': '19.29', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose Period', 'unitOfMeasure': 'microgram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '145.3', 'spread': '10.0', 'groupId': 'OG002'}, {'value': '208.5', 'spread': '44.0', 'groupId': 'OG003'}, {'value': '320.2', 'spread': '12.9', 'groupId': 'OG004'}, {'value': '363.4', 'spread': '38.7', 'groupId': 'OG005'}, {'value': '391.9', 'spread': '14.0', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose Period', 'unitOfMeasure': 'microgram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '39.8', 'groupId': 'OG000'}, {'value': '92.7', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '331.5', 'spread': '14.6', 'groupId': 'OG002'}, {'value': '459.2', 'spread': '32.7', 'groupId': 'OG003'}, {'value': '706.7', 'spread': '17.7', 'groupId': 'OG004'}, {'value': '952.7', 'spread': '42.4', 'groupId': 'OG005'}, {'value': '865.0', 'spread': '34.6', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'unitOfMeasure': 'microgram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '4.00'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '1.00'}, {'value': '0.53', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '1.98'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '0.57', 'upperLimit': '1.00'}, {'value': '1.03', 'groupId': 'OG004', 'lowerLimit': '0.53', 'upperLimit': '2.20'}, {'value': '1.54', 'groupId': 'OG005', 'lowerLimit': '0.53', 'upperLimit': '2.08'}, {'value': '1.03', 'groupId': 'OG006', 'lowerLimit': '1.03', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '15.97', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '28.77', 'groupId': 'OG001'}, {'value': '3.30', 'spread': '22.85', 'groupId': 'OG002'}, {'value': '5.19', 'spread': '18.64', 'groupId': 'OG003'}, {'value': '6.68', 'spread': '39.61', 'groupId': 'OG004'}, {'value': '5.93', 'spread': '66.03', 'groupId': 'OG005'}, {'value': '5.17', 'spread': '19.51', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'unitOfMeasure': 'microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '164.9', 'spread': '69.8', 'groupId': 'OG000'}, {'value': '100.5', 'spread': '30.9', 'groupId': 'OG001'}, {'value': '143.7', 'spread': '34.8', 'groupId': 'OG002'}, {'value': '138.9', 'spread': '22.6', 'groupId': 'OG003'}, {'value': '149.1', 'spread': '26.1', 'groupId': 'OG004'}, {'value': '144.0', 'spread': '68.4', 'groupId': 'OG005'}, {'value': '130.4', 'spread': '37.7', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'description': 'T 1/2 is the time measured for the plasma concentration of MDV3100 to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '131.7', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '90.5', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '91.89', 'spread': '13.31', 'groupId': 'OG002'}, {'value': '103.8', 'spread': '48.5', 'groupId': 'OG003'}, {'value': '108.2', 'spread': '15.8', 'groupId': 'OG004'}, {'value': '97.4', 'spread': '30.7', 'groupId': 'OG005'}, {'value': '126.4', 'spread': '8.8', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of MDV3100 would need to be uniformly distributed to produce the desired plasma concentration of MDV3100. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.', 'unitOfMeasure': 'liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.585', 'spread': '39.810', 'groupId': 'OG000'}, {'value': '0.647', 'spread': '18.988', 'groupId': 'OG001'}, {'value': '0.453', 'spread': '14.583', 'groupId': 'OG002'}, {'value': '0.523', 'spread': '32.679', 'groupId': 'OG003'}, {'value': '0.509', 'spread': '17.711', 'groupId': 'OG004'}, {'value': '0.504', 'spread': '42.437', 'groupId': 'OG005'}, {'value': '0.694', 'spread': '34.625', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'description': 'Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.', 'unitOfMeasure': 'liters per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '109.8', 'spread': '34.4', 'groupId': 'OG001'}, {'value': '291.7', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '395.7', 'spread': '27.4', 'groupId': 'OG003'}, {'value': '488.9', 'spread': '23.9', 'groupId': 'OG004'}, {'value': '463.1', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period', 'unitOfMeasure': 'microgram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.92'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '23.67'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '25.80'}, {'value': '1.08', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '26.17'}, {'value': '1.57', 'groupId': 'OG004', 'lowerLimit': '0.48', 'upperLimit': '24.08'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'spread': '21.10', 'groupId': 'OG000'}, {'value': '5.49', 'spread': '28.88', 'groupId': 'OG001'}, {'value': '14.07', 'spread': '25.36', 'groupId': 'OG002'}, {'value': '18.91', 'spread': '26.57', 'groupId': 'OG003'}, {'value': '24.57', 'spread': '21.00', 'groupId': 'OG004'}, {'value': '27.90', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period', 'unitOfMeasure': 'microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG005'}, {'value': '1.89', 'spread': '0.55', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 of Multiple Dose Period', 'unitOfMeasure': 'microgram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.507', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '0.580', 'spread': '0.245', 'groupId': 'OG001'}, {'value': '0.530', 'spread': '0.149', 'groupId': 'OG002'}, {'value': '0.628', 'spread': '0.179', 'groupId': 'OG003'}, {'value': '0.755', 'spread': '0.176', 'groupId': 'OG004'}, {'value': '1.037', 'spread': 'NA', 'comment': 'Standard deviation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period', 'description': 'Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.', 'unitOfMeasure': 'liters per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Prostate Specific Antigen (PSA) Response at Day 84: Multiple Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'OG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '29.1', 'upperLimit': '70.9'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '44.7', 'upperLimit': '84.4'}, {'value': '75.0', 'groupId': 'OG003', 'lowerLimit': '50.9', 'upperLimit': '91.3'}, {'value': '71.4', 'groupId': 'OG004', 'lowerLimit': '47.8', 'upperLimit': '88.7'}, {'value': '45.5', 'groupId': 'OG005', 'lowerLimit': '16.7', 'upperLimit': '76.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 84', 'description': 'Prostate-specific antigen is a glycoprotein considered as a biomarker for the response to therapy in men with prostate cancer. A 50 percent (%) decline in PSA from baseline to the PSA level at Day 84 was considered as a PSA response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MDV3100 (Enzalutamide): No Previous Chemotherapy', 'description': 'Participants with no prior exposure to chemotherapy received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 milligram per day (mg/day) dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the maximum tolerated dose (MTD) was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, dose limiting toxicity (DLT) or disease progression occurred. Participants were followed up for 30 days after last dose of study drug for safety follow up.'}, {'id': 'FG001', 'title': 'MDV3100 (Enzalutamide): Post Chemotherapy', 'description': 'Participants with prior exposure to chemotherapy single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period, for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, DLT or disease progression occurred. Participants were followed up for 30 days after last dose.'}], 'periods': [{'title': 'Single Dose Period: 1 Week', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': '30 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '60 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '150/160 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': '240 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '360 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': '480 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': '600 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Multiple Dose Period: 12 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who completed single dose period + new participants enrolled in multiple dose period.', 'groupId': 'FG000', 'numSubjects': '65'}, {'comment': 'Participants who completed single dose period + new participants enrolled in multiple dose period.', 'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': '30 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '60 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': '150/160 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': '240 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': '360 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': '480 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': '600 mg/Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'PSA Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Radiologic Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Clinical Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '140', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'MDV3100 (Enzalutamide) 30 mg/Day', 'description': 'Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'BG001', 'title': 'MDV3100 (Enzalutamide) 60 mg /Day', 'description': 'Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'BG002', 'title': 'MDV3100 (Enzalutamide) 150/160 mg/Day', 'description': 'Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'BG003', 'title': 'MDV3100 (Enzalutamide) 240 mg /Day', 'description': 'Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'BG004', 'title': 'MDV3100 (Enzalutamide) 360 mg /Day', 'description': 'Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'BG005', 'title': 'MDV3100 (Enzalutamide) 480 mg /Day', 'description': 'Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'BG006', 'title': 'MDV3100 (Enzalutamide) 600 mg /Day', 'description': 'Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '86', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '140', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '134', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '135', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all enrolled participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2007-07-31', 'resultsFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2007-07-31', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-10', 'studyFirstPostDateStruct': {'date': '2007-08-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Prostate Specific Antigen (PSA) Response at Day 84: Multiple Dose Period', 'timeFrame': 'Baseline, Day 84', 'description': 'Prostate-specific antigen is a glycoprotein considered as a biomarker for the response to therapy in men with prostate cancer. A 50 percent (%) decline in PSA from baseline to the PSA level at Day 84 was considered as a PSA response.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)', 'description': 'An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.'}, {'measure': 'Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period', 'timeFrame': 'Baseline up to first 35 days of the study treatment in multiple dose period', 'description': "DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs."}, {'measure': 'Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period', 'timeFrame': 'Baseline up to first 35 days of the study treatment in multiple dose period', 'description': 'Tolerability was defined as if less than (\\<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and \\< 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if \\<8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose Period'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose Period'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period'}, {'measure': 'Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'description': 'T 1/2 is the time measured for the plasma concentration of MDV3100 to decrease by one half.'}, {'measure': 'Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of MDV3100 would need to be uniformly distributed to produce the desired plasma concentration of MDV3100. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.'}, {'measure': 'Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period', 'description': 'Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period'}, {'measure': 'Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period', 'timeFrame': 'Pre-dose on Day 1 of Multiple Dose Period'}, {'measure': 'Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period', 'description': 'Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate', 'Cancer', 'Hormone', 'Refractory', 'Castration'], 'conditions': ['Prostate Cancer', 'Hormone Refractory Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '25917876', 'type': 'DERIVED', 'citation': 'Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.'}, {'pmid': '20398925', 'type': 'DERIVED', 'citation': 'Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL; Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010 Apr 24;375(9724):1437-46. doi: 10.1016/S0140-6736(10)60172-9. Epub 2010 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.', 'detailedDescription': 'This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed adenocarcinoma of the prostate;\n2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);\n3. Progressive disease after medical or surgical castration,\n\nExclusion Criteria:\n\n1\\. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);'}, 'identificationModule': {'nctId': 'NCT00510718', 'briefTitle': 'A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer', 'nctIdAliases': ['NCT00513812'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, DOSE-ESCALATION SAFETY AND PHARMACOKINETIC STUDY OF MDV3100 IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER', 'orgStudyIdInfo': {'id': 'S-3100-1-01'}, 'secondaryIdInfos': [{'id': 'C3431009', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MDV3100', 'interventionNames': ['Drug: MDV3100']}], 'interventions': [{'name': 'MDV3100', 'type': 'DRUG', 'otherNames': ['enzalutamide', 'Xtandi'], 'description': 'MDV3100 daily until progression or dose-limiting toxicity', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute (DFCI)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center (BIDMC)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'MSKCC- Sidney Kimmel Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Pharmacy Services', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Pfizer Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, {'name': 'Medivation LLC, a wholly owned subsidiary of Pfizer Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}