Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-08 @ 11:03 PM
Study NCT ID:
NCT01605227
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2012-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558660', 'term': 'cabozantinib'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'druginfo@exelixis.com', 'phone': '855-292-3935', 'title': 'Exelixis Medical Information', 'organization': 'Exelixis, Inc.'}, 'certainAgreement': {'otherDetails': "Our agreements with investigators vary; constant is our right to review results communications prior to public release, and embargo communications for a period of ≤60 days from submittal for review. We do not prohibit investigators from publishing, but we may require previously undisclosed confidential information, other than study results, to be removed from publications, and single-center publications are postponed until after publication of the trial's primary multicenter publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 92 weeks', 'description': 'Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).', 'eventGroups': [{'id': 'EG000', 'title': 'Cabozantinib', 'description': 'Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.\n\nCabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.', 'otherNumAtRisk': 681, 'otherNumAffected': 675, 'seriousNumAtRisk': 681, 'seriousNumAffected': 420}, {'id': 'EG001', 'title': 'Prednisone', 'description': 'Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.\n\nPrednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.', 'otherNumAtRisk': 342, 'otherNumAffected': 332, 'seriousNumAtRisk': 342, 'seriousNumAffected': 181}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 111}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 100}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 349}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 390}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Stomatits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 271}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 67}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 228}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 338}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 119}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Muscosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 237}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 41}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 407}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 99}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 64}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 63}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 180}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 46}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Stress cardiomyopathy', 'stats': 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'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Scrotal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Venous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Radiculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 681, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib', 'description': 'Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.\n\nCabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.'}, {'id': 'OG001', 'title': 'Prednisone', 'description': 'Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.\n\nPrednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '10.09', 'upperLimit': '11.63'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '9.00', 'upperLimit': '11.53'}]}]}], 'analyses': [{'pValue': '0.213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.06', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.'}], 'paramType': 'MEDIAN', 'timeFrame': 'OS was measured from the time of randomization until 614 events, approximately 24 months after study start', 'description': 'The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent to Treat (ITT) population was used and included 1028 randomized subjects (682 cabozantinib, 346 prednisone).'}, {'type': 'SECONDARY', 'title': 'Bone Scan Response (BSR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib', 'description': 'Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.\n\nCabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.'}, {'id': 'OG001', 'title': 'Prednisone', 'description': 'Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.\n\nPrednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '46'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.'}], 'paramType': 'NUMBER', 'timeFrame': 'BSR was measured at the end of Week 12 as determined by the IRF', 'description': 'BSR is defined as \\>=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was conducted on the ITT population (682 cabozantinib, 346 prednisone) for Bone Scan Response (BSR) at Week 12.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cabozantinib', 'description': 'Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.\n\nCabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.'}, {'id': 'OG001', 'title': 'Prednisone', 'description': 'Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.\n\nPrednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '5.49', 'upperLimit': '5.62'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': '2.86'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.57', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.'}], 'paramType': 'MEDIAN', 'timeFrame': "Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months", 'description': "The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent to Treat (ITT) population was used and include 1028 randomized subjects (682 cabozantinib, 346 prednisone) with a data cut off date of 07 July 2014.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cabozantinib', 'description': 'Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.\n\nCabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.'}, {'id': 'FG001', 'title': 'Prednisone', 'description': 'Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.\n\nPrednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '682'}, {'groupId': 'FG001', 'numSubjects': '346'}]}, {'type': 'COMPLETED', 'comment': 'Subjects still on study treatment at data cut-off date', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '621'}, {'groupId': 'FG001', 'numSubjects': '329'}]}], 'dropWithdraws': [{'type': 'Did not receive study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'Clinical Deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Started New Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Dose Held >6 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First patient enrolled: 02 July 2012 (first subject randomized), Data cut off date: 07 July 2014'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '1028', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cabozantinib', 'description': 'Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.\n\nCabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.'}, {'id': 'BG001', 'title': 'Prednisone', 'description': 'Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.\n\nPrednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '517', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '766', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '682', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '1028', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '520', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '785', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '528', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '784', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior cabazitaxel (per CRF)', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '421', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '635', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Brief Pain Inventory (BPI) Item 3 (per CRF)', 'classes': [{'categories': [{'title': '<4', 'measurements': [{'value': '389', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}, {'title': '≥4', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Pain will be assessed using the BPI Items #3 (worst pain over the last 24 hours by recall).', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status (per CRF)', 'classes': [{'title': '0/1 (asymptomatic or symptomatic but ambulatory)', 'categories': [{'measurements': [{'value': '605', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '908', 'groupId': 'BG002'}]}]}, {'title': "2 (ambulatory but can't carry out work activities)", 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Opioid narcotic use within 24 hours (per solicited oploid CRF)', 'classes': [{'categories': [{'measurements': [{'value': '454', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '682', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant prednisone/prednisolone at randomization', 'classes': [{'categories': [{'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from diagnosis to study entry', 'classes': [{'categories': [{'measurements': [{'value': '6.68', 'groupId': 'BG000', 'lowerLimit': '0.09', 'upperLimit': '26.6'}, {'value': '6.98', 'groupId': 'BG001', 'lowerLimit': '0.04', 'upperLimit': '22.2'}, {'value': '6.83', 'groupId': 'BG002', 'lowerLimit': '0.04', 'upperLimit': '26.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Bone scan lesion area', 'classes': [{'categories': [{'measurements': [{'value': '45,635.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '388,052'}, {'value': '41,746.0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '283,304'}, {'value': '44,782.0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '388,052'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Extent of metastasis', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Bone', 'categories': [{'measurements': [{'value': '681', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '1027', 'groupId': 'BG002'}]}]}, {'title': 'Lymph node', 'categories': [{'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}]}, {'title': 'Visceral', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Other soft tissue', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'No. of prior anticancer agents', 'classes': [{'title': '2', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': '≥3', 'categories': [{'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '940', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Excluding agents to maintain castration status', 'unitOfMeasure': 'participants'}, {'title': 'Baseline LDH', 'classes': [{'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '6004'}, {'value': '230', 'groupId': 'BG001', 'lowerLimit': '87', 'upperLimit': '3062'}, {'value': '230', 'groupId': 'BG002', 'lowerLimit': '59', 'upperLimit': '6004'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline PSA', 'classes': [{'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000', 'lowerLimit': '0.02', 'upperLimit': '10030'}, {'value': '195', 'groupId': 'BG001', 'lowerLimit': '0.54', 'upperLimit': '10963'}, {'value': '192', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '10963'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'FULL_RANGE'}, {'title': 'Baseline serum testosterone (<50 ng/dL)', 'classes': [{'categories': [{'measurements': [{'value': '677', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '1022', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1028}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2012-05-22', 'resultsFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-14', 'studyFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': "Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months", 'description': "The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration."}], 'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'OS was measured from the time of randomization until 614 events, approximately 24 months after study start', 'description': 'The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.'}], 'secondaryOutcomes': [{'measure': 'Bone Scan Response (BSR)', 'timeFrame': 'BSR was measured at the end of Week 12 as determined by the IRF', 'description': 'BSR is defined as \\>=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer', 'castration resistant prostate cancer', 'bone pain', 'CRPC'], 'conditions': ['Prostate Cancer', 'Castration Resistant Prostate Cancer', 'Pain', 'Prostatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '29272162', 'type': 'DERIVED', 'citation': 'Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.'}, {'pmid': '27400947', 'type': 'DERIVED', 'citation': 'Smith M, De Bono J, Sternberg C, Le Moulec S, Oudard S, De Giorgi U, Krainer M, Bergman A, Hoelzer W, De Wit R, Bogemann M, Saad F, Cruciani G, Thiery-Vuillemin A, Feyerabend S, Miller K, Houede N, Hussain S, Lam E, Polikoff J, Stenzl A, Mainwaring P, Ramies D, Hessel C, Weitzman A, Fizazi K. Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1. J Clin Oncol. 2016 Sep 1;34(25):3005-13. doi: 10.1200/JCO.2015.65.5597. Epub 2016 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL).\n* Evidence of bone metastasis related to prostate cancer on bone scans.\n* Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of prostate cancer progression on each agent independently.\n* Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.\n* Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable.\n* Adequate organ and marrow function.\n* Capable of understanding and complying with the protocol requirements and signed the informed consent form.\n* Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Prior treatment with cabozantinib.\n* Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.\n* Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization.\n* Known brain metastases or cranial epidural disease.\n* Requires concomitant treatment, in therapeutic doses, with anticoagulants.\n* Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).\n* Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.\n* Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.\n* Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.\n* QTcF \\> 500 ms within 7 days of randomization.\n* Unable to swallow capsules or tablets.\n* Previously-identified allergy or hypersensitivity to components of the study treatment formulations.\n* Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization."}, 'identificationModule': {'nctId': 'NCT01605227', 'acronym': 'COMET-1', 'briefTitle': 'Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exelixis'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100', 'orgStudyIdInfo': {'id': 'XL184-307'}, 'secondaryIdInfos': [{'id': '2012-001834-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cabozantinib', 'description': 'Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.', 'interventionNames': ['Drug: cabozantinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prednisone', 'description': 'Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.', 'interventionNames': ['Drug: prednisone']}], 'interventions': [{'name': 'cabozantinib', 'type': 'DRUG', 'otherNames': ['XL184'], 'description': 'Tablets taken orally once-daily', 'armGroupLabels': ['cabozantinib']}, {'name': 'prednisone', 'type': 'DRUG', 'description': 'Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.', 'armGroupLabels': ['prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92346', 'city': 'Highland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.12834, 'lon': -117.20865}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92069', 'city': 'San Marcos', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.14337, 'lon': -117.16614}}, {'zip': '94574', 'city': 'St. Helena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.50519, 'lon': -122.47026}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06489', 'city': 'Southington', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.59649, 'lon': -72.8776}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 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{'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '41701', 'city': 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'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01844', 'city': 'Methuen', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.7262, 'lon': -71.19089}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49509', 'city': 'Wyoming', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65109', 'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 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