Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT01597193
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2012-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540278', 'term': 'enzalutamide'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C056516', 'term': 'exemestane'}, {'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, '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}, 'limitationsAndCaveats': {'description': "Prioritization of outcome measures as primary and secondary was based on the study team's discretion."}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', '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 one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 21, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymph Node Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eye Movement Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eyelid Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abnormal Sensation In Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, 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'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hallucination, Visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis Erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'In-Stent Coronary Artery Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pathological Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tumour Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Obstructive Uropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ureteric Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 35', 'description': 'DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (\\>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade \\>=3 hematologic toxicity with the following modifications: 1) Grade \\>=3 platelet count associated with bleeding, 2) Grade \\>=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade \\>=3 any other non-hematological toxicity that was determined to be related to study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}, {'value': '37.5', 'groupId': 'OG004'}, {'value': '39.1', 'groupId': 'OG005'}, {'value': '36.4', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE Version 4.03 and defined as Grade 3 AEs = severe or medically significant events but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living; Grade 4 AEs = life-threatening, urgent intervention indicated; Grade 5 AEs = death related to adverse event.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '5.0', 'groupId': 'OG003'}, {'value': '31.3', 'groupId': 'OG004'}, {'value': '13.0', 'groupId': 'OG005'}, {'value': '18.2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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 or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}, {'value': '5.0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}, {'value': '13.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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 or incapacity, congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Require Dose Reductions Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}, {'value': '8.7', 'groupId': 'OG005'}, {'value': '18.2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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 or incapacity, congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Blood pressure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Heart rate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'Absolute systolic blood pressure (SBP) greater than (\\>) 180 millimeter of mercury (mm Hg) and an increase of \\>40 mm Hg from baseline; absolute SBP less than (\\<) 90 mm Hg and an decrease of \\>30 mm Hg from baseline. Absolute diastolic blood pressure (DBP) \\>105 mm Hg and an increase of \\>30 mm Hg from baseline; absolute DBP \\<50 mm Hg and an increase of \\>20 mm Hg from baseline. Absolute heart rate \\>120 beats per minute (bpm) and an increase of \\>30 bpm from baseline; absolute heart rate \\<50 bpm and decrease of \\>20 bpm from baseline. Participants with any of these abnormalities were reported for this outcome in each arm.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '1.90', 'spread': '0.757', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '2.09', 'groupId': 'OG001'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '0.0375', 'spread': '0.0286', 'groupId': 'OG000'}, {'value': '0.0707', 'spread': '0.0379', 'groupId': 'OG001'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '0.0879', 'spread': '0.0718', 'groupId': 'OG000'}, {'value': '0.184', 'spread': '0.0689', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '0.500', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.350', 'upperLimit': '4.00'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '25.1'}, {'value': '23.1', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '23.9'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '25.1'}, {'value': '23.7', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '24.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '17.3', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '41.6', 'spread': '8.19', 'groupId': 'OG001'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '0.632', 'spread': '0.385', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.648', 'groupId': 'OG001'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.916', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.', 'unitOfMeasure': 'micrograms*hour per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '107', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1', 'unitOfMeasure': 'micrograms*hour per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '208', 'spread': '66.0', 'groupId': 'OG000'}, {'value': '478', 'spread': '232', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).', 'unitOfMeasure': 'micrograms*hour per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '280', 'spread': '170', 'groupId': 'OG000'}, {'value': '198', 'spread': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Terminal elimination half-life is the time measured for the plasma concentration of Enzalutamide to decrease by one-half of its initial concentration.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.426', 'spread': '0.160', 'groupId': 'OG000'}, {'value': '0.382', 'spread': '0.115', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.', 'unitOfMeasure': 'liter per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'spread': '73.6', 'groupId': 'OG000'}, {'value': '94.5', 'spread': '13.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.', 'unitOfMeasure': 'liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '11.6', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.521', 'groupId': 'OG000'}, {'value': '6.24', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '6.42', 'spread': '0.132', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '0.500', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '5.50'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.570', 'upperLimit': '4.00'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '5.70', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '24.0'}, {'value': '2.29', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '24.0'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '0.570', 'upperLimit': '24.0'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '207', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '325', 'spread': '61.6', 'groupId': 'OG001'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '33.0', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '120', 'spread': '56.0', 'groupId': 'OG001'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '140', 'spread': '6.08', 'groupId': 'OG000'}, {'value': '317', 'spread': '89.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.', 'unitOfMeasure': 'milligram*hour per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.390', 'spread': '0.0491', 'groupId': 'OG000'}, {'value': '0.507', 'spread': '0.0906', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.', 'unitOfMeasure': 'liter per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.400', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.174', 'groupId': 'OG001'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.407', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.388', 'groupId': 'OG001'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '0.999', 'spread': '0.0012', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.0420', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Peak-to-trough ratio was calculated by dividing Cmax with Cmin of Enzalutamide and its Metabolites. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'title': 'Enzalutamide', 'categories': [{'measurements': [{'value': '17.9', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '9.39', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': 'M1', 'categories': [{'measurements': [{'value': '47.6', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '68.0', 'spread': '35.8', 'groupId': 'OG001'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '157', 'spread': '48.2', 'groupId': 'OG000'}, {'value': '77.8', 'spread': '35.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50', 'description': 'Accumulation Ratio was defined as the ratio of AUC24 of Day 50 to AUC24 of Day 1, where AUC24 was area under the plasma concentration-time curve from time zero to 24 hours post-dose. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG001', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG002', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'OG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.40', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '14.33', 'spread': '3.99', 'groupId': 'OG001'}, {'value': '13.52', 'spread': '2.62', 'groupId': 'OG002'}, {'value': '12.41', 'spread': '3.76', 'groupId': 'OG003'}, {'value': '11.62', 'spread': '4.69', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose on Day 57', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 milligram (mg) (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'FG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'FG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'FG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'FG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'FG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'FG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}], 'periods': [{'title': 'Stage 1: Dose Escalation (141 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Stage 2: Dose Expansion (1067 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '11'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Stage 1: Included participants with incurable breast cancer. Stage 2: Included participants with hormone receptor-positive incurable breast cancer.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '99', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Escalation: Enzalutamide 80 mg', 'description': 'Participants received enzalutamide 80 mg (two 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'BG001', 'title': 'Dose Escalation: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'BG002', 'title': 'Dose Expansion: Enzalutamide 160 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsules, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'BG003', 'title': 'Dose Expansion: Enzalutamide 160 mg + Anastrozole 1 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the anastrozole 1 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'BG004', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 25 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 25 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'BG005', 'title': 'Dose Expansion: Enzalutamide 160 mg + Exemestane 50 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule in combination with the exemestane 50 mg tablet, orally, once daily until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'BG006', 'title': 'Dose Expansion: Enzalutamide 160 mg + Fulvestrant 500 mg', 'description': 'Participants received enzalutamide 160 mg (four 40 mg) capsule once daily in combination with the fulvestrant 500 mg intramuscular injection, once every 28 days until documented disease progression, initiation of a new antitumor treatment, an intolerable adverse event (including any seizure), noncompliance, withdrawal of consent, discontinuation by the sponsor, or investigator. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor or investigational therapy, whichever occurred first.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 65 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '63', 'groupId': 'BG007'}]}]}, {'title': 'Between 65 to 74 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}]}]}, {'title': 'Greater than or equal to (>=) 75 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '99', 'groupId': 'BG007'}]}, {'title': 'Male', '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 analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2012-05-09', 'resultsFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-07', 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)', 'timeFrame': 'Baseline up to Day 35', 'description': 'DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (\\>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade \\>=3 hematologic toxicity with the following modifications: 1) Grade \\>=3 platelet count associated with bleeding, 2) Grade \\>=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade \\>=3 any other non-hematological toxicity that was determined to be related to study drug.'}, {'measure': 'Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE Version 4.03 and defined as Grade 3 AEs = severe or medically significant events but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living; Grade 4 AEs = life-threatening, urgent intervention indicated; Grade 5 AEs = death related to adverse event.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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 or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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 or incapacity, congenital anomaly.'}, {'measure': 'Percentage of Participants Who Require Dose Reductions Due to Adverse Events', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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 or incapacity, congenital anomaly.'}, {'measure': 'Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)', 'description': 'Absolute systolic blood pressure (SBP) greater than (\\>) 180 millimeter of mercury (mm Hg) and an increase of \\>40 mm Hg from baseline; absolute SBP less than (\\<) 90 mm Hg and an decrease of \\>30 mm Hg from baseline. Absolute diastolic blood pressure (DBP) \\>105 mm Hg and an increase of \\>30 mm Hg from baseline; absolute DBP \\<50 mm Hg and an increase of \\>20 mm Hg from baseline. Absolute heart rate \\>120 beats per minute (bpm) and an increase of \\>30 bpm from baseline; absolute heart rate \\<50 bpm and decrease of \\>20 bpm from baseline. Participants with any of these abnormalities were reported for this outcome in each arm.'}, {'measure': 'Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.'}, {'measure': 'Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.'}, {'measure': 'Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.'}, {'measure': 'Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1'}, {'measure': 'Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).'}, {'measure': 'Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Terminal elimination half-life is the time measured for the plasma concentration of Enzalutamide to decrease by one-half of its initial concentration.'}, {'measure': 'Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.'}, {'measure': 'Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.'}, {'measure': 'Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.'}, {'measure': 'Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.'}, {'measure': 'Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.'}, {'measure': 'Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.'}, {'measure': 'Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50', 'description': 'Peak-to-trough ratio was calculated by dividing Cmax with Cmin of Enzalutamide and its Metabolites. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.'}, {'measure': 'Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing', 'timeFrame': 'pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50', 'description': 'Accumulation Ratio was defined as the ratio of AUC24 of Day 50 to AUC24 of Day 1, where AUC24 was area under the plasma concentration-time curve from time zero to 24 hours post-dose. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.'}], 'secondaryOutcomes': [{'measure': 'Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide', 'timeFrame': 'pre-dose on Day 57'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['enzalutamide', 'MDV3100', 'breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed breast cancer with accompanying pathology report;\n* Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides\n* Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);\n* Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;\n* Estimated life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;\n* Pregnant or lactating;\n* Known or suspected brain metastasis or leptomeningeal disease;\n* History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;\n* For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.'}, 'identificationModule': {'nctId': 'NCT01597193', 'briefTitle': 'Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER', 'orgStudyIdInfo': {'id': 'MDV3100-08'}, 'secondaryIdInfos': [{'id': 'C3431006', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'enzalutamide (80-mg with increase to 160 mg)', 'description': 'enzalutamide be provided as two or four 40-mg capsules by mouth daily', 'interventionNames': ['Drug: enzalutamide']}, {'type': 'EXPERIMENTAL', 'label': 'enzalutamide and anastrozole', 'description': 'enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily.', 'interventionNames': ['Drug: anastrozole', 'Drug: enzalutamide']}, {'type': 'EXPERIMENTAL', 'label': 'enzalutamide and exemestane 25 mg', 'description': 'enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily', 'interventionNames': ['Drug: exemestane', 'Drug: enzalutamide']}, {'type': 'EXPERIMENTAL', 'label': 'enzalutamide and exemestane 50 mg', 'description': 'enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily', 'interventionNames': ['Drug: enzalutamide', 'Drug: exemestane']}, {'type': 'EXPERIMENTAL', 'label': 'enzalutamide and fulvestrant', 'description': 'enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days', 'interventionNames': ['Drug: fulvestrant', 'Drug: enzalutamide']}], 'interventions': [{'name': 'enzalutamide', 'type': 'DRUG', 'otherNames': ['MDV3100, Xtandi'], 'description': '80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.', 'armGroupLabels': ['enzalutamide (80-mg with increase to 160 mg)']}, {'name': 'anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex'], 'description': '1 mg/day', 'armGroupLabels': ['enzalutamide and anastrozole']}, {'name': 'exemestane', 'type': 'DRUG', 'otherNames': ['Aromasin'], 'description': 'The exemestane dose is 25mg daily.', 'armGroupLabels': ['enzalutamide and exemestane 25 mg']}, {'name': 'fulvestrant', 'type': 'DRUG', 'otherNames': ['Faslodex'], 'description': '500 mg every 28 days', 'armGroupLabels': ['enzalutamide and fulvestrant']}, {'name': 'enzalutamide', 'type': 'DRUG', 'otherNames': ['MDV3100', 'Xtandi'], 'description': '160 mg (4 capsules) taken orally daily.', 'armGroupLabels': ['enzalutamide and anastrozole', 'enzalutamide and exemestane 25 mg', 'enzalutamide and exemestane 50 mg', 'enzalutamide and fulvestrant']}, {'name': 'exemestane', 'type': 'DRUG', 'otherNames': ['Aromasin'], 'description': 'The exemestane dose is 50 mg daily.', 'armGroupLabels': ['enzalutamide and exemestane 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'ATTN-Research Pharmacist', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital, Anschutz Outpatient Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06082', 'city': 'Enfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Multispecialty Group', 'geoPoint': {'lat': 41.97621, 'lon': -72.59176}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '38834', 'city': 'Corinth', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The West Clinic, PC', 'geoPoint': {'lat': 34.93425, 'lon': -88.52227}}, {'zip': '38671', 'city': 'Southaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 34.98898, 'lon': -90.01259}}, {'zip': '10022', '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': 'Memorial Sloan Kettering Cancer Center - IDS Pharmacy', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center - OPD Pharmacy', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'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': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], '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'}}}}