Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00699751
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2008-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'India']}, 'interventionBrowseModule': {'meshes': [{'id': 'C581106', 'term': 'radium Ra 223 dichloride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'No PI may disclose or publish information from the trial before publication of the principal and first communication arising from the trial, unless 12 months has elapsed after completion of the trial. There is restriction on the PI that the sponsor can review results communication prior to public release and can embargo regarding trial results for a period that is less/or equal to 60 days from the time submitted to the sponsor for review. Sponsor cannot require changes or extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent AEs (TEAEs) data were collected after the first injection of study treatment and within 12 weeks after the last injection of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Subjects received BSoC plus radium-223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.', 'otherNumAffected': 524, 'seriousNumAffected': 286}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase.', 'otherNumAffected': 254, 'seriousNumAffected': 185}, {'id': 'EG002', 'title': 'Placebo Randomized, Then Switched to Radium-223 Dichloride', 'description': 'Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.', 'otherNumAffected': 23, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 247, 'numAffected': 161}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 104, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 37, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 71, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 111, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 68, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 242, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 60, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 294, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 126, 'numAffected': 98}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 151, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 43, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 192, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 86, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 82, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 58, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 55, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 74, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 45, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 115, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 57, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 39, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 476, 'numAffected': 287}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 321, 'numAffected': 174}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 53, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 54, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 70, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 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'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Prostatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Scrotal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '16.1'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '12.8'}]}]}], 'analyses': [{'pValue': '0.00005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.691', 'ciLowerLimit': '0.578', 'ciUpperLimit': '0.827', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)', 'description': 'Overall survival was defined as the time from date of randomization to the date of death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population was defined as all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Time to Total Alkaline Phosphatase (ALP) Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'comment': '95% Confidence Interval upper limit is not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': 'NA'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.169', 'ciLowerLimit': '0.131', 'ciUpperLimit': '0.22', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first ALP progression until approximately 3 years after start of enrollment', 'description': 'The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Total ALP Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': '>=30% reduction of ALP in blood level', 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction of ALP in blood level', 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Confirmed Total ALP Response (>=30%)', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Confirmed Total ALP Response (>=50%)', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=30% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=50% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Confirmed Total ALP Response (\\>=30%)', 'groupDescription': 'The null hypothesis for the comparison of Confirmed Total ALP Response (\\>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Confirmed Total ALP Response (\\>=50%)', 'groupDescription': 'The null hypothesis for the comparison of Confirmed Total ALP Response (\\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline and Week 12', 'description': "ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either \\>/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': '>=30% reduction of ALP in blood level', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction of ALP in blood level', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Confirmed Total ALP Response (>=50%)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=30% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=50% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Confirmed Total ALP Response (\\>=50%)', 'groupDescription': 'The null hypothesis for the comparison of Confirmed Total ALP Response (\\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (\\>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Total ALP Normalization at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Total ALP normalization', 'groupDescription': 'The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline and Week 12', 'description': 'The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Total ALP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.2', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '2.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Percentage Change from Baseline', 'groupDescription': 'The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Baseline and Week 12', 'description': "ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)\\*100", 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Percentage Decrease From Baseline in Total ALP up to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.9', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Maximum Percentage decrease from baseline to week 12', 'groupDescription': 'The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 12', 'description': "ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of \\[(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.9', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '62.1', 'spread': '4.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Percentage change from baseline', 'groupDescription': 'The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)\\*100", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.4', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Maximum Percentage decrease from baseline during the 24 week treatment', 'groupDescription': 'The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline During the 24 Week Treatment', 'description': "ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of \\[(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Time to Prostate Specific Antigen (PSA) Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '3.8'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.5'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.643', 'ciLowerLimit': '0.539', 'ciUpperLimit': '0.768', 'pValueComment': 'Time to Prostate Specific Antigen (PSA) progression', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first PSA progression until approximately 3 years after start of enrollment', 'description': 'The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PSA Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': '>=30% reduction of PSA in blood level', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction of PSA in blood level', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Confirmed PSA Response (>=50%)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=30% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '0.106', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=50% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Confirmed PSA Response(\\>=50%)', 'groupDescription': 'The null hypothesis for the comparison of Confirmed PSA Response(\\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline and Week 12', 'description': "PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (\\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': '>=30% reduction in blood level', 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': '>=50% reduction in blood level', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Confirmed PSA Response (>=50%)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=30% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\>=50% reduction in blood level', 'groupDescription': 'The null hypothesis for the comparison of \\>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Confirmed PSA Response(\\>=50%)', 'groupDescription': 'The null hypothesis for the comparison of Confirmed PSA Response(\\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (\\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in PSA at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'spread': '152.48', 'groupId': 'OG000'}, {'value': '543.8', 'spread': '233.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.160', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Percentage change from baseline in PSA at Week 12', 'groupDescription': 'The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Baseline and Week 12', 'description': "PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)\\*100", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Percentage Decrease From Baseline in PSA up to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.0', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Maximum Percentage Decrease from Baseline up to Week 12', 'groupDescription': 'The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline up to Week 12', 'description': "PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of \\[(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '144.3', 'spread': '15.38', 'groupId': 'OG000'}, {'value': '191.1', 'spread': '22.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Percentage change from baseline in PSA at EOT', 'groupDescription': 'The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)\\*100", 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.4', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period', 'groupDescription': 'The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to End of Treatment (Week 24; 4 weeks post last injection)', 'description': "PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of \\[(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline.", 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and had no missing values for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Time to First Skeletal Related Event (SRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '18.3'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '11.9'}]}]}], 'analyses': [{'pValue': '0.00012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.657', 'ciLowerLimit': '0.529', 'ciUpperLimit': '0.814', 'pValueComment': 'Time to first Skeletal Related Event (SRE)', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first first SRE until approximately 3 years after start of enrollment', 'description': 'A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '20.6'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '18.5'}]}]}], 'analyses': [{'pValue': '0.00008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.639', 'ciLowerLimit': '0.511', 'ciUpperLimit': '0.8', 'pValueComment': 'Time to External Beam Radiotherapy', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first EBRT until approximately 3 years after start of enrollment', 'description': 'The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median survival time is not reached', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median survival time is not reached', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.00191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.344', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.695', 'pValueComment': 'stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first use of radioisotopes until approximately 3 years after start of enrollment', 'description': 'The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median survival time is not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median survival time is not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.53277', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.847', 'ciLowerLimit': '0.504', 'ciUpperLimit': '1.426', 'pValueComment': 'Time to Pathological Bone Fracture', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment', 'description': 'The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median survival time is not reached', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median survival time is not reached', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.89567', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.949', 'ciLowerLimit': '0.435', 'ciUpperLimit': '2.07', 'pValueComment': 'Time to Surgical Intervention', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment', 'description': 'The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of First Spinal Cord Compression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median survival time is not reached', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median survival time is not reached', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.14486', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.404', 'ciUpperLimit': '1.145', 'pValueComment': 'Time to Spinal Cord Compression', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first spinal cord compression until approximately 3 years after start of enrollment', 'description': 'The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of First Start of Any Other Anti-cancer Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '17'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '14.7'}]}]}], 'analyses': [{'pValue': '0.00932', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.727', 'ciLowerLimit': '0.571', 'ciUpperLimit': '0.925', 'pValueComment': 'Time to Other Cancer Treatment', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment', 'description': 'The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000', 'lowerLimit': '20.4', 'upperLimit': '26.5'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '24.5'}]}]}], 'analyses': [{'pValue': '0.00187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.546', 'ciUpperLimit': '0.873', 'pValueComment': 'Time to Marked Deterioration of ECOG PS', 'estimateComment': 'The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'groupDescription': 'The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment', 'description': 'ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'ECOG Grade 0', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 1', 'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 2', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and with ECOG analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'ECOG Grade 0', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 1', 'categories': [{'measurements': [{'value': '315', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 2', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and with ECOG analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'ECOG Grade 0', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 1', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 2', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 3', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and with ECOG analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'ECOG Grade 0', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 1', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 2', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 3', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ECOG Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in The ITT population and with ECOG analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'Week 0 (Baseline)', 'categories': [{'measurements': [{'value': '65.00', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '104.0'}, {'value': '64.00', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '96.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '65.00', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '98.0'}, {'value': '61.31', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '96.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '61.00', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '102.0'}, {'value': '60.00', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '97.0'}]}]}, {'title': 'Follow-up Visit 2 (Week 42)', 'categories': [{'measurements': [{'value': '61.00', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '95.0'}, {'value': '60.5', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '97.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'At Week 16', 'categories': [{'measurements': [{'value': '-1.55', 'groupId': 'OG000', 'lowerLimit': '-49.3', 'upperLimit': '38.0'}, {'value': '-4.15', 'groupId': 'OG001', 'lowerLimit': '-43.0', 'upperLimit': '46.0'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '-4.00', 'groupId': 'OG000', 'lowerLimit': '-60.4', 'upperLimit': '40.0'}, {'value': '-5.67', 'groupId': 'OG001', 'lowerLimit': '-39.0', 'upperLimit': '41.0'}]}]}, {'title': 'At Follow-up Visit 2 (Week 42)', 'categories': [{'measurements': [{'value': '-5.00', 'groupId': 'OG000', 'lowerLimit': '-89.0', 'upperLimit': '44.5'}, {'value': '-5.5', 'groupId': 'OG001', 'lowerLimit': '-47.4', 'upperLimit': '25.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'physical well being', 'categories': [{'measurements': [{'value': '20.00', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '28.0'}, {'value': '19.83', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '28.0'}]}]}, {'title': 'social/family well being', 'categories': [{'measurements': [{'value': '22.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '28.0'}, {'value': '21.50', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.0'}]}]}, {'title': 'emotional well being', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '24.0'}, {'value': '16.80', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '24.0'}]}]}, {'title': 'functional well being', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '28.0'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.0'}]}]}, {'title': 'the prostate cancer subscale', 'categories': [{'measurements': [{'value': '29.00', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '46.9'}, {'value': '27.60', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '42.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 16', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'physical well being', 'categories': [{'measurements': [{'value': '19.00', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '28.0'}, {'value': '18.67', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '28.0'}]}]}, {'title': 'social/family well being', 'categories': [{'measurements': [{'value': '21.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '28.0'}, {'value': '21.00', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '28.0'}]}]}, {'title': 'emotional well being', 'categories': [{'measurements': [{'value': '17.00', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '24.0'}, {'value': '16.00', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '24.0'}]}]}, {'title': 'functional well being', 'categories': [{'measurements': [{'value': '15.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '28.0'}, {'value': '14.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.0'}]}]}, {'title': 'the prostate cancer subscale', 'categories': [{'measurements': [{'value': '28.00', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '46.0'}, {'value': '27.64', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 24', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'physical well being', 'categories': [{'measurements': [{'value': '19.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '28.0'}, {'value': '18.00', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '28.0'}]}]}, {'title': 'social/family well being', 'categories': [{'measurements': [{'value': '22.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '28.0'}, {'value': '22.00', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '33.8'}]}]}, {'title': 'emotional well being', 'categories': [{'measurements': [{'value': '17.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '24.0'}, {'value': '16.00', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '24.0'}]}]}, {'title': 'functional well being', 'categories': [{'measurements': [{'value': '14.00', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '28.0'}, {'value': '14.00', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '28.0'}]}]}, {'title': 'the prostate cancer subscale', 'categories': [{'measurements': [{'value': '28.00', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '42.0'}, {'value': '29.00', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'At Week 16', 'categories': [{'measurements': [{'value': '100.68', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '147.0'}, {'value': '99.90', 'groupId': 'OG001', 'lowerLimit': '33.7', 'upperLimit': '144.0'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '98.00', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '152.0'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '47.0', 'upperLimit': '149.0'}]}]}, {'title': 'At Follow-up Visit 2 (Week 42)', 'categories': [{'measurements': [{'value': '97.83', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '145.0'}, {'value': '97.38', 'groupId': 'OG001', 'lowerLimit': '40.9', 'upperLimit': '147.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'At Week 16', 'categories': [{'measurements': [{'value': '-2.00', 'groupId': 'OG000', 'lowerLimit': '-58.0', 'upperLimit': '58.0'}, {'value': '-5.67', 'groupId': 'OG001', 'lowerLimit': '-58.0', 'upperLimit': '47'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '-5.00', 'groupId': 'OG000', 'lowerLimit': '-67.2', 'upperLimit': '63.5'}, {'value': '-9.40', 'groupId': 'OG001', 'lowerLimit': '-42.8', 'upperLimit': '48.8'}]}]}, {'title': 'At Follow-up Visit 2 (Week 42)', 'categories': [{'measurements': [{'value': '-6.17', 'groupId': 'OG000', 'lowerLimit': '-97.0', 'upperLimit': '63.5'}, {'value': '-7.00', 'groupId': 'OG001', 'lowerLimit': '-54.7', 'upperLimit': '23.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'At Week 16', 'categories': [{'measurements': [{'value': '73.00', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '106.0'}, {'value': '72.00', 'groupId': 'OG001', 'lowerLimit': '27.7', 'upperLimit': '108.0'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '71.00', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '107.0'}, {'value': '69.00', 'groupId': 'OG001', 'lowerLimit': '37.0', 'upperLimit': '106.0'}]}]}, {'title': 'At Follow-up Visit 2 (Week 42)', 'categories': [{'measurements': [{'value': '70.00', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '107.0'}, {'value': '70.25', 'groupId': 'OG001', 'lowerLimit': '32.2', 'upperLimit': '104.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'At Week 16', 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-38.3', 'upperLimit': '40.0'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-53.0', 'upperLimit': '32.8'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '-4.08', 'groupId': 'OG000', 'lowerLimit': '-49.0', 'upperLimit': '49.5'}, {'value': '-7.00', 'groupId': 'OG001', 'lowerLimit': '-35.8', 'upperLimit': '41.8'}]}]}, {'title': 'At Follow-up Visit 2 (Week 42)', 'categories': [{'measurements': [{'value': '-3.67', 'groupId': 'OG000', 'lowerLimit': '-58.0', 'upperLimit': '40.5'}, {'value': '-6.00', 'groupId': 'OG001', 'lowerLimit': '-33.8', 'upperLimit': '18.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'mobility - Grade 1', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Grade 2', 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 1', 'categories': [{'measurements': [{'value': '346', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 2', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 1', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 2', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 3', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 1', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 2', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 3', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 1', 'categories': [{'measurements': [{'value': '285', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 2', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 3', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects with with EQ-5D analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'mobility - Grade 1', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Grade 2', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Grade 3', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 1', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 2', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 1', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 2', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 3', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 1', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 2', 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 3', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 1', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 2', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects with with EQ-5D analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}], 'classes': [{'title': 'mobility - Grade 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Grade 2', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'mobility - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 1', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 2', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'self-care - Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'self-care - MIssing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Grade 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'usual activities - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 2', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'pain/discomfort - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'anxiety/depression - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up Visit 8 (Week 139)', 'description': "The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was all randomized subjects with with EQ-5D analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Participants received BSoC plus radium223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.'}], 'periods': [{'title': 'Period 1: Without/Before Drug Switch', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '614'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '600'}, {'groupId': 'FG001', 'numSubjects': '301'}]}, {'type': 'Entered 3-Year Follow-up Period', 'achievements': [{'comment': 'Participants were not required to complete all 6 injections to enter to 3-year follow-up period.', 'groupId': 'FG000', 'numSubjects': '407'}, {'comment': 'Participants were not required to complete all 6 injections to enter to 3-year follow-up period.', 'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'Completed 3-Year Follow-up Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed all 6 injections', 'groupId': 'FG000', 'numSubjects': '389'}, {'comment': 'Completed all 6 injections', 'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '162'}]}], 'dropWithdraws': [{'type': 'Investigator Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Subject Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '63'}]}]}, {'title': 'Period 2:Switched From Placebo to Xofigo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants in the placebo group switched to Xofigo treatment', 'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Entered 3-Year Follow-up Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Completed 3-Year Follow-up Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Completed all 6 injections', 'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Investigator Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Completion page not expected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Subjects with progressive symptomatic hormone refractory prostate cancer (HRPC), with at least 2 skeletal metastases on bone scan and no known visceral metastases, could participate in the study.', 'preAssignmentDetails': 'Subjects were to be randomized in a 2:1, a total of 921 subjects were enrolled in the study and were randomized to receive either Alpharadin \\[Radium-223 dichloride (Xofigo, BAY88-8223)\\] or placebo study treatment, which resulted in 614 subjects enrolled in the Alpharadin group and 307 enrolled in the placebo group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '921', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Radium-223 Dichloride (Xofigo, BAY88-8223)', 'description': 'Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'spread': '8.10', 'groupId': 'BG000'}, {'value': '70.8', 'spread': '7.87', 'groupId': 'BG001'}, {'value': '70.4', 'spread': '8.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '614', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '921', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Alkaline Phosphatase (ALP)', 'classes': [{'title': '< 220 U/L', 'categories': [{'measurements': [{'value': '348', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}]}, {'title': '≥ 220 U/L', 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The total amount of ALP in the blood was determined at baseline.', 'unitOfMeasure': 'Participants'}, {'title': 'Current use of bisphosphonates', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '547', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects may have been on bisphosphonate therapy during the study.', 'unitOfMeasure': 'Participants'}, {'title': 'Any prior use of docetaxel', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '526', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 921}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2008-06-17', 'resultsFirstSubmitDate': '2013-06-29', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-08', 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.', 'timeFrame': 'Week 0', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.'}, {'measure': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.', 'timeFrame': 'Week 8', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.'}, {'measure': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.', 'timeFrame': 'Week 16', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.'}, {'measure': 'Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.', 'timeFrame': 'Week 24', 'description': 'ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about \\> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.'}, {'measure': 'Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI)', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).'}, {'measure': 'Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.'}, {'measure': 'Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16', 'timeFrame': 'At Week 16', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.'}, {'measure': 'Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24', 'timeFrame': 'At Week 24', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.'}, {'measure': 'Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)', 'timeFrame': 'At Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.'}, {'measure': 'Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'timeFrame': 'At Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).'}, {'measure': 'Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)', 'description': 'The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.'}, {'measure': 'Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'timeFrame': 'At Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).'}, {'measure': 'Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'timeFrame': 'Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)', 'description': 'The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.'}, {'measure': 'Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16', 'timeFrame': 'Week 16', 'description': "The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems')."}, {'measure': 'Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24', 'timeFrame': 'Week 24', 'description': "The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems')."}, {'measure': 'Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)', 'timeFrame': 'Follow-up Visit 8 (Week 139)', 'description': "The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems')."}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)', 'description': 'Overall survival was defined as the time from date of randomization to the date of death.'}], 'secondaryOutcomes': [{'measure': 'Time to Total Alkaline Phosphatase (ALP) Progression', 'timeFrame': 'From randomization to first ALP progression until approximately 3 years after start of enrollment', 'description': 'The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later'}, {'measure': 'Percentage of Participants With Total ALP Response at Week 12', 'timeFrame': 'At Baseline and Week 12', 'description': "ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either \\>/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later."}, {'measure': 'Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (\\>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later."}, {'measure': 'Percentage of Participants With Total ALP Normalization at Week 12', 'timeFrame': 'At Baseline and Week 12', 'description': 'The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.'}, {'measure': 'Percentage Change From Baseline in Total ALP at Week 12', 'timeFrame': 'At Baseline and Week 12', 'description': "ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)\\*100"}, {'measure': 'Maximum Percentage Decrease From Baseline in Total ALP up to Week 12', 'timeFrame': 'From baseline to Week 12', 'description': "ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of \\[(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline."}, {'measure': 'Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)\\*100"}, {'measure': 'Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment', 'timeFrame': 'From baseline During the 24 Week Treatment', 'description': "ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of \\[(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline."}, {'measure': 'Time to Prostate Specific Antigen (PSA) Progression', 'timeFrame': 'From randomization to first PSA progression until approximately 3 years after start of enrollment', 'description': 'The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later'}, {'measure': 'Percentage of Participants With PSA Response at Week 12', 'timeFrame': 'At Baseline and Week 12', 'description': "PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (\\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later."}, {'measure': 'Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (\\>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later."}, {'measure': 'Percentage Change From Baseline in PSA at Week 12', 'timeFrame': 'At Baseline and Week 12', 'description': "PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)\\*100"}, {'measure': 'Maximum Percentage Decrease From Baseline in PSA up to Week 12', 'timeFrame': 'From baseline up to Week 12', 'description': "PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of \\[(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline."}, {'measure': 'Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)', 'timeFrame': 'At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)', 'description': "PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)\\*100"}, {'measure': 'Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period', 'timeFrame': 'From baseline to End of Treatment (Week 24; 4 weeks post last injection)', 'description': "PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of \\[(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)\\*100\\] by participant, and set to zero if no decrease from baseline."}, {'measure': 'Time to First Skeletal Related Event (SRE)', 'timeFrame': 'From randomization to first first SRE until approximately 3 years after start of enrollment', 'description': 'A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.'}, {'measure': 'Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms', 'timeFrame': 'From randomization to first EBRT until approximately 3 years after start of enrollment', 'description': 'The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.'}, {'measure': 'Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms', 'timeFrame': 'From randomization to first use of radioisotopes until approximately 3 years after start of enrollment', 'description': 'The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.'}, {'measure': 'Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral', 'timeFrame': 'From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment', 'description': 'The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.'}, {'measure': 'Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention', 'timeFrame': 'From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment', 'description': 'The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.'}, {'measure': 'Time to Occurrence of First Spinal Cord Compression', 'timeFrame': 'From randomization to first spinal cord compression until approximately 3 years after start of enrollment', 'description': 'The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.'}, {'measure': 'Time to Occurrence of First Start of Any Other Anti-cancer Treatment', 'timeFrame': 'From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment', 'description': 'The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.'}, {'measure': 'Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline', 'timeFrame': 'From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment', 'description': 'ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hormone Refractory Prostate Cancer', 'Bone Metastases', 'Radium-223'], 'conditions': ['Hormone Refractory Prostate Cancer', 'Bone Metastases']}, 'referencesModule': {'references': [{'pmid': '23863050', 'type': 'RESULT', 'citation': "Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755."}, {'pmid': '25439694', 'type': 'RESULT', 'citation': "Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17."}, {'pmid': '24836273', 'type': 'RESULT', 'citation': "Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland OS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13."}, {'pmid': '25840395', 'type': 'RESULT', 'citation': 'Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. Nursing management of patients with castration-resistant prostate cancer undergoing radium-223 dichloride treatment. Clin J Oncol Nurs. 2015 Apr;19(2):E31-5. doi: 10.1188/15.CJON.E31-E35.'}, {'pmid': '25832684', 'type': 'RESULT', 'citation': 'Humm JL, Sartor O, Parker C, Bruland OS, Macklis R. Radium-223 in the treatment of osteoblastic metastases: a critical clinical review. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):898-906. doi: 10.1016/j.ijrobp.2014.12.061.'}, {'pmid': '24857093', 'type': 'RESULT', 'citation': 'Nilsson S. Alpha-emitter radium-223 in the management of solid tumors: current status and future directions. Am Soc Clin Oncol Educ Book. 2014:e132-9. doi: 10.14694/EdBook_AM.2014.34.e132.'}, {'pmid': '24775727', 'type': 'RESULT', 'citation': 'Den RB, Doyle LA, Knudsen KE. Practical guide to the use of radium 223 dichloride. Can J Urol. 2014 Apr;21(2 Supp 1):70-6.'}, {'pmid': '24610703', 'type': 'RESULT', 'citation': 'Shirley M, McCormack PL. Radium-223 dichloride: a review of its use in patients with castration-resistant prostate cancer with symptomatic bone metastases. Drugs. 2014 Apr;74(5):579-86. doi: 10.1007/s40265-014-0198-4.'}, {'pmid': '24052017', 'type': 'RESULT', 'citation': 'Wissing MD, van Leeuwen FW, van der Pluijm G, Gelderblom H. Radium-223 chloride: Extending life in prostate cancer patients by treating bone metastases. Clin Cancer Res. 2013 Nov 1;19(21):5822-7. doi: 10.1158/1078-0432.CCR-13-1896. Epub 2013 Sep 19.'}, {'pmid': '23977665', 'type': 'RESULT', 'citation': 'Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride in castration-resistant prostate cancer. Drugs Today (Barc). 2013 Aug;49(8):483-90. doi: 10.1358/dot.2013.49.8.1968670.'}, {'pmid': '27930924', 'type': 'DERIVED', 'citation': "Parker C, Zhan L, Cislo P, Reuning-Scherer J, Vogelzang NJ, Nilsson S, Sartor O, O'Sullivan JM, Coleman RE. Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. Eur J Cancer. 2017 Jan;71:1-6. doi: 10.1016/j.ejca.2016.10.020. Epub 2016 Dec 6."}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.', 'detailedDescription': "The aim of the study was to compare, in patients with symptomatic hormone refractory prostate cancer (HRPC) and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).\n\nPatients were randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consisted of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient were followed until 3 years after first study drug administration.\n\nWithin the U.S., the trial was conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals.\n\nAll patients received BSoC (Best Standard of Care).\n\nThis study has the original PCD as 14 October 2010, when a total of 316 deaths had been observed; this resulted in the Independent Data Monitoring Committee's (IDMC's) recommendation to stop the study as the primary efficacy analysis of overall survival had crossed the pre-specified boundary for efficacy. Later an updated analysis of primary endpoint in the first addendum was done with cut-off of 15 July 2011."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Known hormone refractory disease\n* Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy\n* No intention to use cytotoxic chemotherapy within the next 6 months\n* Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain\n\nExclusion Criteria:\n\n* Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period\n* Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available\n* Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago\n* Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks\n* Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)\n* History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks'}, 'identificationModule': {'nctId': 'NCT00699751', 'acronym': 'ALSYMPCA', 'briefTitle': 'A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases', 'orgStudyIdInfo': {'id': '15245'}, 'secondaryIdInfos': [{'id': 'BC1-06', 'type': 'OTHER', 'domain': 'Algeta ASA'}, {'id': '2007-006195-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radium-223 dichloride (Xofigo, BAY88-8223)', 'description': 'Participants received radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).', 'interventionNames': ['Drug: Radium-223 dichloride (Xofigo, BAY88-8223)', 'Drug: Best standard of care (BSoC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).', 'interventionNames': ['Drug: Placebo', 'Drug: Best standard of care (BSoC)']}], 'interventions': [{'name': 'Radium-223 dichloride (Xofigo, BAY88-8223)', 'type': 'DRUG', 'otherNames': ['Alpharadin'], 'description': 'Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.', 'armGroupLabels': ['Radium-223 dichloride (Xofigo, BAY88-8223)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Isotonic saline 6 IV administrations separated by 4 weeks intervals.', 'armGroupLabels': ['Placebo']}, {'name': 'Best standard of care (BSoC)', 'type': 'DRUG', 'description': 'Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.', 'armGroupLabels': ['Placebo', 'Radium-223 dichloride (Xofigo, BAY88-8223)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048-0750', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '19111-2497', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '2521', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4350', 'city': 'Toowoomba', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 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