Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT01308567
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552428', 'term': 'cabazitaxel'}, {'id': 'C532412', 'term': 'XRP6258'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.', 'description': "Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population, which was randomized participants who received study drug and analyzed according to the treatment actually received.", 'eventGroups': [{'id': 'EG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.", 'otherNumAtRisk': 387, 'otherNumAffected': 353, 'seriousNumAtRisk': 387, 'seriousNumAffected': 126}, {'id': 'EG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.", 'otherNumAtRisk': 369, 'otherNumAffected': 323, 'seriousNumAtRisk': 369, 'seriousNumAffected': 127}, {'id': 'EG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.", 'otherNumAtRisk': 391, 'otherNumAffected': 354, 'seriousNumAtRisk': 391, 'seriousNumAffected': 188}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 74}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 120}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 190}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 125}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 51}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 91}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 90}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 126}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Incorrect dose administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}], 'seriousEvents': [{'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Abscess jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Abscess oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 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'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urethritis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urinary bladder rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Urinary tract pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Cystitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Recall phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Wrong drug administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}, {'term': 'Device issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 387, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 391, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '22.18', 'upperLimit': '27.60'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '21.75', 'upperLimit': '27.20'}, {'value': '25.2', 'groupId': 'OG002', 'lowerLimit': '22.90', 'upperLimit': '26.97'}]}]}], 'analyses': [{'pValue': '0.7574', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.975', 'ciLowerLimit': '0.819', 'ciUpperLimit': '1.16', 'pValueComment': 'P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479', 'estimateComment': 'Cabazitaxel 25 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.009', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.197', 'pValueComment': 'P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479', 'estimateComment': 'Cabazitaxel 20 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )', 'description': "OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '4.86', 'upperLimit': '5.78'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.91', 'upperLimit': '5.09'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '4.60', 'upperLimit': '5.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.989', 'ciLowerLimit': '0.849', 'ciUpperLimit': '1.152', 'estimateComment': 'Cabazitaxel 25 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.063', 'ciLowerLimit': '0.913', 'ciUpperLimit': '1.236', 'estimateComment': 'Cabazitaxel 20 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)', 'description': 'PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '11.30', 'upperLimit': '13.77'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '11.37', 'upperLimit': '14.75'}, {'value': '13.1', 'groupId': 'OG002', 'lowerLimit': '11.66', 'upperLimit': '14.32'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.958', 'ciLowerLimit': '0.785', 'ciUpperLimit': '1.17', 'estimateComment': 'Cabazitaxel 25 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.916', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.118', 'estimateComment': 'Cabazitaxel 20 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Objective Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '37.7'}, {'value': '32.4', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '39.1'}, {'value': '41.6', 'groupId': 'OG002', 'lowerLimit': '34.3', 'upperLimit': '49.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed for specified outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '7.66', 'upperLimit': '9.20'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.43', 'upperLimit': '8.90'}, {'value': '9.2', 'groupId': 'OG002', 'lowerLimit': '8.44', 'upperLimit': '9.92'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.948', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.123', 'estimateComment': 'Cabazitaxel 25 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.047', 'ciLowerLimit': '0.886', 'ciUpperLimit': '1.238', 'estimateComment': 'Cabazitaxel 20 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'Time to PSA-PFS: time interval between date of randomization \\& first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA \\<10 ng/mL):(a)in participants with baseline PSA\\>0 ng/mL\\&\\<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PSA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '63.5', 'upperLimit': '73.2'}, {'value': '60.7', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '65.8'}, {'value': '68.7', 'groupId': 'OG002', 'lowerLimit': '63.8', 'upperLimit': '73.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Pain Progression Free Survival (Pain PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.28', 'upperLimit': '11.76'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.90', 'upperLimit': '9.66'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '6.44', 'upperLimit': '9.30'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.189', 'ciLowerLimit': '0.986', 'ciUpperLimit': '1.434', 'estimateComment': 'Cabazitaxel 25 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.189', 'ciLowerLimit': '0.985', 'ciUpperLimit': '1.435', 'estimateComment': 'Cabazitaxel 20 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)', 'description': 'Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '51.4'}, {'value': '42.4', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '52.2'}, {'value': '39.4', 'groupId': 'OG002', 'lowerLimit': '30.0', 'upperLimit': '48.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)', 'description': 'Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. Number of participants analyzed=participants with pain score with median PPI \\>= 2 and/or mean analgesic score \\>= 10 points at baseline and at least one valid post-baseline value for specified outcome measure.'}, {'type': 'SECONDARY', 'title': 'Skeletal Related Events (SRE) Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '15.24', 'upperLimit': '22.44'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '15.21', 'upperLimit': '24.61'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '14.59', 'upperLimit': '20.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.121', 'ciLowerLimit': '0.886', 'ciUpperLimit': '1.417', 'estimateComment': 'Cabazitaxel 25 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.014', 'ciLowerLimit': '0.798', 'ciUpperLimit': '1.288', 'estimateComment': 'Cabazitaxel 20 mg/m\\^2 vs Docetaxel 75 mg/m\\^2', 'groupDescription': 'Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until occurrence of first SRE or death (maximum duration: 51 months)', 'description': 'SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'title': 'Change at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '321', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '7.05'}, {'value': '7.66', 'groupId': 'OG001', 'lowerLimit': '4.79', 'upperLimit': '10.53'}, {'value': '6.93', 'groupId': 'OG002', 'lowerLimit': '3.97', 'upperLimit': '9.88'}]}]}, {'title': 'Change at Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '323', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.33', 'groupId': 'OG000', 'lowerLimit': '2.46', 'upperLimit': '8.2'}, {'value': '7.15', 'groupId': 'OG001', 'lowerLimit': '4.28', 'upperLimit': '10.01'}, {'value': '5.28', 'groupId': 'OG002', 'lowerLimit': '2.32', 'upperLimit': '8.24'}]}]}, {'title': 'Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '316', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.94', 'groupId': 'OG000', 'lowerLimit': '2.06', 'upperLimit': '7.82'}, {'value': '6.79', 'groupId': 'OG001', 'lowerLimit': '3.93', 'upperLimit': '9.66'}, {'value': '4.61', 'groupId': 'OG002', 'lowerLimit': '1.64', 'upperLimit': '7.58'}]}]}, {'title': 'Change at Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.07', 'groupId': 'OG000', 'lowerLimit': '1.17', 'upperLimit': '6.96'}, {'value': '5.22', 'groupId': 'OG001', 'lowerLimit': '2.35', 'upperLimit': '8.09'}, {'value': '4.01', 'groupId': 'OG002', 'lowerLimit': '1.03', 'upperLimit': '6.99'}]}]}, {'title': 'Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '283', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.36', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '7.27'}, {'value': '5.16', 'groupId': 'OG001', 'lowerLimit': '2.26', 'upperLimit': '8.06'}, {'value': '4.09', 'groupId': 'OG002', 'lowerLimit': '1.09', 'upperLimit': '7.08'}]}]}, {'title': 'Change at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.46', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '6.39'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '6.73'}, {'value': '3.37', 'groupId': 'OG002', 'lowerLimit': '0.35', 'upperLimit': '6.39'}]}]}, {'title': 'Change at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.16', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.12'}, {'value': '3.66', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '6.61'}, {'value': '3.42', 'groupId': 'OG002', 'lowerLimit': '0.38', 'upperLimit': '6.45'}]}]}, {'title': 'Change at Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '-0.37', 'upperLimit': '5.59'}, {'value': '2.71', 'groupId': 'OG001', 'lowerLimit': '-0.27', 'upperLimit': '5.68'}, {'value': '1.67', 'groupId': 'OG002', 'lowerLimit': '-1.39', 'upperLimit': '4.73'}]}]}, {'title': 'Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-0.87', 'upperLimit': '5.27'}, {'value': '2.67', 'groupId': 'OG001', 'lowerLimit': '-0.35', 'upperLimit': '5.68'}, {'value': '1.89', 'groupId': 'OG002', 'lowerLimit': '-1.22', 'upperLimit': '5.01'}]}]}, {'title': 'Change at Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000', 'lowerLimit': '-1.05', 'upperLimit': '5.21'}, {'value': '2.09', 'groupId': 'OG001', 'lowerLimit': '-0.99', 'upperLimit': '5.18'}, {'value': '1.84', 'groupId': 'OG002', 'lowerLimit': '-1.32', 'upperLimit': '5'}]}]}, {'title': 'Change at Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '-3.18', 'upperLimit': '3.47'}, {'value': '3.35', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '6.6'}, {'value': '2.68', 'groupId': 'OG002', 'lowerLimit': '-0.67', 'upperLimit': '6.02'}]}]}, {'title': 'Change at Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '-2.94', 'upperLimit': '3.97'}, {'value': '3.95', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '7.29'}, {'value': '0.63', 'groupId': 'OG002', 'lowerLimit': '-2.78', 'upperLimit': '4.05'}]}]}, {'title': 'Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000', 'lowerLimit': '-1.94', 'upperLimit': '5.53'}, {'value': '2.48', 'groupId': 'OG001', 'lowerLimit': '-0.95', 'upperLimit': '5.91'}, {'value': '0.55', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '4.09'}]}]}, {'title': 'Change at Cycle 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.78', 'groupId': 'OG000', 'lowerLimit': '-5.56', 'upperLimit': '2'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '-1.29', 'upperLimit': '5.69'}, {'value': '-0.42', 'groupId': 'OG002', 'lowerLimit': '-4.06', 'upperLimit': '3.21'}]}]}, {'title': 'Change at Cycle 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.49', 'groupId': 'OG000', 'lowerLimit': '-7.5', 'upperLimit': '0.51'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '-1.82', 'upperLimit': '5.3'}, {'value': '1.22', 'groupId': 'OG002', 'lowerLimit': '-2.51', 'upperLimit': '4.95'}]}]}, {'title': 'Change at Cycle 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.83', 'groupId': 'OG000', 'lowerLimit': '-7.89', 'upperLimit': '0.23'}, {'value': '1.62', 'groupId': 'OG001', 'lowerLimit': '-2.11', 'upperLimit': '5.35'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-3.3', 'upperLimit': '4.3'}]}]}, {'title': 'Change at Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.08', 'groupId': 'OG000', 'lowerLimit': '-4.15', 'upperLimit': '1.99'}, {'value': '-1.45', 'groupId': 'OG001', 'lowerLimit': '-4.48', 'upperLimit': '1.59'}, {'value': '-1.82', 'groupId': 'OG002', 'lowerLimit': '-4.97', 'upperLimit': '1.32'}]}]}, {'title': 'Change at Follow-up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-3.16', 'upperLimit': '3.13'}, {'value': '-1.98', 'groupId': 'OG001', 'lowerLimit': '-5.17', 'upperLimit': '1.21'}, {'value': '-1.78', 'groupId': 'OG002', 'lowerLimit': '-5.04', 'upperLimit': '1.47'}]}]}, {'title': 'Change at Follow-up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000', 'lowerLimit': '-3.83', 'upperLimit': '2.74'}, {'value': '-2.16', 'groupId': 'OG001', 'lowerLimit': '-5.47', 'upperLimit': '1.14'}, {'value': '-2.68', 'groupId': 'OG002', 'lowerLimit': '-6.08', 'upperLimit': '0.72'}]}]}, {'title': 'Change at Follow-up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.19', 'groupId': 'OG000', 'lowerLimit': '-4.61', 'upperLimit': '2.23'}, {'value': '-3.64', 'groupId': 'OG001', 'lowerLimit': '-7.18', 'upperLimit': '-0.1'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-5.25', 'upperLimit': '1.84'}]}]}, {'title': 'Change at Follow-up 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.05', 'groupId': 'OG000', 'lowerLimit': '-5.61', 'upperLimit': '1.51'}, {'value': '-6.73', 'groupId': 'OG001', 'lowerLimit': '-10.39', 'upperLimit': '-3.06'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-4.18', 'upperLimit': '2.99'}]}]}, {'title': 'Change at Follow-up 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'groupId': 'OG000', 'lowerLimit': '-4.92', 'upperLimit': '2.58'}, {'value': '-5.36', 'groupId': 'OG001', 'lowerLimit': '-9.32', 'upperLimit': '-1.4'}, {'value': '-4.05', 'groupId': 'OG002', 'lowerLimit': '-7.87', 'upperLimit': '-0.23'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)', 'description': 'FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'OG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'classes': [{'title': 'Change at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.31', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '5.58'}, {'value': '6.09', 'groupId': 'OG001', 'lowerLimit': '3.83', 'upperLimit': '8.35'}, {'value': '5.76', 'groupId': 'OG002', 'lowerLimit': '3.43', 'upperLimit': '8.09'}]}]}, {'title': 'Change at Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.37', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '6.64'}, {'value': '5.96', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '8.21'}, {'value': '4.26', 'groupId': 'OG002', 'lowerLimit': '1.92', 'upperLimit': '6.59'}]}]}, {'title': 'Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.31', 'groupId': 'OG000', 'lowerLimit': '2.04', 'upperLimit': '6.58'}, {'value': '5.28', 'groupId': 'OG001', 'lowerLimit': '3.02', 'upperLimit': '7.53'}, {'value': '3.65', 'groupId': 'OG002', 'lowerLimit': '1.31', 'upperLimit': '5.99'}]}]}, {'title': 'Change at Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.39', 'groupId': 'OG000', 'lowerLimit': '1.11', 'upperLimit': '5.67'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '6.36'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '0.85', 'upperLimit': '5.55'}]}]}, {'title': 'Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000', 'lowerLimit': '1.11', 'upperLimit': '5.7'}, {'value': '4.05', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '6.34'}, {'value': '3.1', 'groupId': 'OG002', 'lowerLimit': '0.74', 'upperLimit': '5.46'}]}]}, {'title': 'Change at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000', 'lowerLimit': '0.45', 'upperLimit': '5.07'}, {'value': '3.15', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '5.46'}, {'value': '2.88', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '5.26'}]}]}, {'title': 'Change at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '240', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.29', 'groupId': 'OG000', 'lowerLimit': '-0.05', 'upperLimit': '4.62'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '0.81', 'upperLimit': '5.47'}, {'value': '2.94', 'groupId': 'OG002', 'lowerLimit': '0.54', 'upperLimit': '5.34'}]}]}, {'title': 'Change at Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000', 'lowerLimit': '-0.69', 'upperLimit': '4.02'}, {'value': '2.26', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '4.61'}, {'value': '1.49', 'groupId': 'OG002', 'lowerLimit': '-0.92', 'upperLimit': '3.91'}]}]}, {'title': 'Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '4.18'}, {'value': '2.15', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '4.53'}, {'value': '1.73', 'groupId': 'OG002', 'lowerLimit': '-0.73', 'upperLimit': '4.19'}]}]}, {'title': 'Change at Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.52', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '4'}, {'value': '1.56', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '3.99'}, {'value': '1.62', 'groupId': 'OG002', 'lowerLimit': '-0.89', 'upperLimit': '4.12'}]}]}, {'title': 'Change at Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '-2.29', 'upperLimit': '3'}, {'value': '2.72', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '5.3'}, {'value': '2.19', 'groupId': 'OG002', 'lowerLimit': '-0.46', 'upperLimit': '4.84'}]}]}, {'title': 'Change at Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '3.79'}, {'value': '3.08', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '5.73'}, {'value': '0.75', 'groupId': 'OG002', 'lowerLimit': '-1.95', 'upperLimit': '3.46'}]}]}, {'title': 'Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000', 'lowerLimit': '-0.85', 'upperLimit': '5.11'}, {'value': '1.78', 'groupId': 'OG001', 'lowerLimit': '-0.94', 'upperLimit': '4.5'}, {'value': '0.82', 'groupId': 'OG002', 'lowerLimit': '-1.98', 'upperLimit': '3.62'}]}]}, {'title': 'Change at Cycle 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-3.15', 'upperLimit': '2.89'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '-1.18', 'upperLimit': '4.36'}, {'value': '-0.07', 'groupId': 'OG002', 'lowerLimit': '-2.95', 'upperLimit': '2.81'}]}]}, {'title': 'Change at Cycle 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-5.29', 'upperLimit': '1.09'}, {'value': '1.29', 'groupId': 'OG001', 'lowerLimit': '-1.53', 'upperLimit': '4.11'}, {'value': '1.49', 'groupId': 'OG002', 'lowerLimit': '-1.47', 'upperLimit': '4.45'}]}]}, {'title': 'Change at Cycle 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.26', 'groupId': 'OG000', 'lowerLimit': '-5.49', 'upperLimit': '0.97'}, {'value': '1.23', 'groupId': 'OG001', 'lowerLimit': '-1.73', 'upperLimit': '4.19'}, {'value': '1.44', 'groupId': 'OG002', 'lowerLimit': '-1.59', 'upperLimit': '4.47'}]}]}, {'title': 'Change at Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-3.38', 'upperLimit': '1.47'}, {'value': '-1.26', 'groupId': 'OG001', 'lowerLimit': '-3.66', 'upperLimit': '1.14'}, {'value': '-1.62', 'groupId': 'OG002', 'lowerLimit': '-4.11', 'upperLimit': '0.86'}]}]}, {'title': 'Change at Follow-up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-2.56', 'upperLimit': '2.42'}, {'value': '-1.12', 'groupId': 'OG001', 'lowerLimit': '-3.65', 'upperLimit': '1.41'}, {'value': '-1.05', 'groupId': 'OG002', 'lowerLimit': '-3.62', 'upperLimit': '1.53'}]}]}, {'title': 'Change at Follow-up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-2.92', 'upperLimit': '2.28'}, {'value': '-1.67', 'groupId': 'OG001', 'lowerLimit': '-4.29', 'upperLimit': '0.96'}, {'value': '-1.98', 'groupId': 'OG002', 'lowerLimit': '-4.68', 'upperLimit': '0.72'}]}]}, {'title': 'Change at Follow-up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'groupId': 'OG000', 'lowerLimit': '-3.62', 'upperLimit': '1.8'}, {'value': '-2.54', 'groupId': 'OG001', 'lowerLimit': '-5.36', 'upperLimit': '0.29'}, {'value': '-1.03', 'groupId': 'OG002', 'lowerLimit': '-3.84', 'upperLimit': '1.78'}]}]}, {'title': 'Change at Follow-up 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.15', 'groupId': 'OG000', 'lowerLimit': '-4.99', 'upperLimit': '0.69'}, {'value': '-5.36', 'groupId': 'OG001', 'lowerLimit': '-8.27', 'upperLimit': '-2.44'}, {'value': '-0.82', 'groupId': 'OG002', 'lowerLimit': '-3.67', 'upperLimit': '2.02'}]}]}, {'title': 'Change at Follow-up 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.77', 'groupId': 'OG000', 'lowerLimit': '-4.75', 'upperLimit': '1.2'}, {'value': '-5.32', 'groupId': 'OG001', 'lowerLimit': '-8.49', 'upperLimit': '-2.16'}, {'value': '-2.76', 'groupId': 'OG002', 'lowerLimit': '-5.82', 'upperLimit': '0.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)', 'description': 'FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = participants with available data for each specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal."}, {'id': 'FG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'FG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized', 'groupId': 'FG000', 'numSubjects': '391'}, {'comment': 'Randomized', 'groupId': 'FG001', 'numSubjects': '389'}, {'comment': 'Randomized', 'groupId': 'FG002', 'numSubjects': '388'}]}, {'type': 'Treated', 'achievements': [{'comment': 'For 1 participant, actual treatment received was Cabazitaxel 25 mg/m\\^2.', 'groupId': 'FG000', 'numSubjects': '388'}, {'comment': 'For 15 participants, actual treatment received was Cabazitaxel 25 mg/m\\^2.', 'groupId': 'FG001', 'numSubjects': '382'}, {'comment': 'For 2 participants, actual treatment received was Cabazitaxel 20 mg/m\\^2.', 'groupId': 'FG002', 'numSubjects': '377'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed participants included those who withdrew treatment consent but were followed for survival.', 'groupId': 'FG000', 'numSubjects': '389'}, {'comment': 'Completed participants included those who withdrew treatment consent but were followed for survival.', 'groupId': 'FG001', 'numSubjects': '385'}, {'comment': 'Completed participants included those who withdrew treatment consent but were followed for survival.', 'groupId': 'FG002', 'numSubjects': '384'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was conducted at 159 centers in 25 countries. A total of 1510 participants were screened between 17 May 2011 and 09 September 2015 of whom 1168 participants were randomized and 342 were considered as screen failures.', 'preAssignmentDetails': 'A total of 1168 participants randomized in this study. Of these, 21 participants randomized but not treated. These participants were included in intent-to-treat (ITT) population, not in safety population. "Study cut-off date" for outcome measures was up to "primary completion date" (PCD) only. After PCD, only adverse event (AE) data was updated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'BG000'}, {'value': '389', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}, {'value': '1168', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'BG001', 'title': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'BG002', 'title': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '376', 'groupId': 'BG003'}]}]}, {'title': '65-74 years', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '550', 'groupId': 'BG003'}]}]}, {'title': '≥75 years', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '389', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}, {'value': '1168', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2011-03-03', 'resultsFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-12', 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )', 'description': "OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method."}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)', 'description': 'PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.'}, {'measure': 'Time to Tumor Progression Free Survival', 'timeFrame': 'Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.'}, {'measure': 'Percentage of Participants With Overall Objective Tumor Response', 'timeFrame': 'Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)', 'timeFrame': 'Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'Time to PSA-PFS: time interval between date of randomization \\& first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA \\<10 ng/mL):(a)in participants with baseline PSA\\>0 ng/mL\\&\\<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.'}, {'measure': 'Percentage of Participants With PSA Response', 'timeFrame': 'Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)', 'description': 'PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.'}, {'measure': 'Time to Pain Progression Free Survival (Pain PFS)', 'timeFrame': 'Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)', 'description': 'Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.'}, {'measure': 'Percentage of Participants With Pain Response', 'timeFrame': 'Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)', 'description': 'Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.'}, {'measure': 'Skeletal Related Events (SRE) Free Survival', 'timeFrame': 'Baseline until occurrence of first SRE or death (maximum duration: 51 months)', 'description': 'SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.'}, {'measure': 'Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)', 'timeFrame': 'Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)', 'description': 'FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.'}, {'measure': 'Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL', 'timeFrame': 'Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)', 'description': 'FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '38364191', 'type': 'DERIVED', 'citation': 'Carrot A, Oudard S, Colomban O, Fizazi K, Maillet D, Sartor O, Freyer G, You B. Prognostic Value of the Modeled Prostate-Specific Antigen KELIM Confirmation in Metastatic Castration-Resistant Prostate Cancer Treated With Taxanes in FIRSTANA. JCO Clin Cancer Inform. 2024 Feb;8:e2300208. doi: 10.1200/CCI.23.00208.'}, {'pmid': '33740734', 'type': 'DERIVED', 'citation': 'Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.'}, {'pmid': '29500065', 'type': 'DERIVED', 'citation': 'Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.'}, {'pmid': '28753384', 'type': 'DERIVED', 'citation': 'Oudard S, Fizazi K, Sengelov L, Daugaard G, Saad F, Hansen S, Hjalm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.'}, {'pmid': '24722180', 'type': 'DERIVED', 'citation': 'de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.'}, {'pmid': '23228299', 'type': 'DERIVED', 'citation': 'Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\\^2 (Arm A) or 20 mg/m\\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.\n\nSecondary Objectives:\n\n* To evaluate safety in the 3 treatment arms.\n* To compare efficacy of cabazitaxel at 20 mg/m\\^2 and 25 mg/m\\^2 to docetaxel for:\n\n * Progression Free Survival (PFS) (RECIST 1.1)\n * Tumor progression free survival (RECIST 1.1)\n * Tumor response in participants with measurable disease (RECIST 1.1),\n * PSA response\n * PSA-Progression free survival (PSA-PFS).\n * Pain response in participants with stable pain at baseline\n * Pain progression free survival\n * Time to occurrence of any skeletal related events (SRE)\n* To compare Health-Related Quality of Life (HRQL).\n* To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.', 'detailedDescription': "Participants were treated until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever comes first."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* I 01. Histologically- or cytologically-confirmed prostate adenocarcinoma.\n* I 02. Metastatic disease.\n* I 03. Progressive disease while receiving hormonal therapy or after surgical castration.\n* I 04. Effective castration (serum testosterone levels ≤0.50 ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone (LHRH) agonists or antagonist with or without anti-androgens.\n\nExclusion criteria:\n\n* E 01. Prior chemotherapy for prostate cancer,\n* E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Participants on biphosphonates prior to study entry.\n* E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to \\>30% of bone marrow.\n* E 04. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade \\>1(National Cancer Institute Common Terminology Criteria \\[NCI CTCAE\\] v4.03) at the time of randomization.\n* E 05. Less than 18 years (or country's legal age of majority if the legal age is \\>18 years).\n* E 06. Eastern Cooperative Oncology Group (ECOG) performance status \\>2.\n* E 07. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.\n* E 08. Prior malignancy.\n* E 09. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.\n* E 10. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack.\n* E 11. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.\n* E 12. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.\n* E 13. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or interfere with interpretation of study results, or participants unable to comply with the study procedures.\n* E 14. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study.\n* E 15. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period.\n* E 16. History of hypersensitivity to docetaxel, or polysorbate 80.\n* E 17. Inadequate organ and bone marrow function\n* E 18. Contraindications to the use of corticosteroid treatment.\n* E 19. Symptomatic peripheral neuropathy grade \\>2 (National Cancer Institute Common Terminology Criteria \\[NCI CTCAE\\] v.4.03).\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01308567', 'acronym': 'FIRSTANA', 'briefTitle': 'Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy', 'orgStudyIdInfo': {'id': 'EFC11784'}, 'secondaryIdInfos': [{'id': '2010-022064-12', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1117-8356', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabazitaxel 25 mg/m^2', 'description': "Cabazitaxel 25 mg/m\\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.", 'interventionNames': ['Drug: Cabazitaxel (XRP6258)', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Cabazitaxel 20 mg/m^2', 'description': "Cabazitaxel 20 mg/m\\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.", 'interventionNames': ['Drug: Cabazitaxel (XRP6258)', 'Drug: Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel 75 mg/m^2', 'description': "Docetaxel (TXT) 75 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.", 'interventionNames': ['Drug: Docetaxel (XRP6976)', 'Drug: Prednisone']}], 'interventions': [{'name': 'Cabazitaxel (XRP6258)', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Intravenous', 'armGroupLabels': ['Cabazitaxel 20 mg/m^2', 'Cabazitaxel 25 mg/m^2']}, {'name': 'Docetaxel (XRP6976)', 'type': 'DRUG', 'description': "Pharmaceutical form: Solution for injection'; Route of administration: Intravenous", 'armGroupLabels': ['Docetaxel 75 mg/m^2']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet; Route of administration: Oral', 'armGroupLabels': ['Cabazitaxel 20 mg/m^2', 'Cabazitaxel 25 mg/m^2', 'Docetaxel 75 mg/m^2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840004', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840009', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840014', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840030', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92404', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840003', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840012', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840019', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840013', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840035', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840001', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840015', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site 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'Belarus', 'facility': 'Investigational Site Number 112002', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '210603', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Investigational Site Number 112004', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '99010-260', 'city': 'Passo Fundo', 'country': 'Brazil', 'facility': 'Investigational Site Number 076006', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'zip': '90035-001', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Investigational Site Number 076001', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Investigational Site Number 076002', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '20230-130', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Investigational Site Number 076004', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'country': 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'Germany', 'facility': 'Investigational Site Number 276002', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Investigational Site Number 276006', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Investigational Site Number 376004', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Investigational Site Number 376003', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Investigational Site Number 376002', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '06156', 'city': 'Arezzo', 'country': 'Italy', 'facility': 'Investigational Site Number 380001', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Investigational Site Number 380004', 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