Viewing Study NCT00134056

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Ignite Creation Date: 2025-12-24 @ 11:18 PM
Ignite Modification Date: 2025-12-25 @ 8:59 PM
Study NCT ID: NCT00134056
Status: COMPLETED
Last Update Posted: 2021-10-27
First Post: 2005-08-22
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077868', 'term': 'Atrasentan'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D052117', 'term': 'Benzodioxoles'}, {'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'diquinn@med.usc.edu', 'phone': '3238653956', 'title': 'Dr. David I Quinn', 'organization': 'University of Southern California Norris Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Assessed every 3 weeks up to 52 weeks', 'description': 'Participants were monitored for toxicity every 3 weeks while on protocol therapy or at more frequent intervals appropriate for that participant, as judged by the treating physician.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.', 'otherNumAtRisk': 486, 'otherNumAffected': 476, 'seriousNumAtRisk': 486, 'seriousNumAffected': 172}, {'id': 'EG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.', 'otherNumAtRisk': 492, 'otherNumAffected': 475, 'seriousNumAtRisk': 492, 'seriousNumAffected': 153}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 350}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 331}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vision-blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Watery eye (epiphora, tearing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 41}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 176}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 149}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry mouth/salivary gland (xerostomia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Heartburn/dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (functional/symp) - Oral cav', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 188}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema: limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 284}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 178}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 357}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 346}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bruising (in absence of Gr 3-4 thrombocytopenia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 80}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 113}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 71}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 165}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 72}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic/Laboratory-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 180}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 47}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 90}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 106}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 75}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 202}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-high (hyperkalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 47}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 61}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle weakness, not d/t neuropathy - body/general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 86}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 156}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 45}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 119}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 104}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 96}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 202}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 223}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Taste alteration (dysgeusia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 132}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 80}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary frequency/urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 58}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 50}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 80}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 197}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 156}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, pulmonary/upper respiratory - Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 29}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nasal cavity/paranasal sinus reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hair loss/Alopecia (scalp or body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 192}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 149}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 70}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot flashes/flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 71}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 35}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 42}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'DIC (disseminated intravascular coagulation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry mouth/salivary gland (xerostomia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia (difficulty swallowing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, 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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Perforation, GI - Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Perforation, GI - Duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 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'Inf (clin/microbio) w/Gr 3-4 neuts - Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf (clin/microbio) w/Gr 3-4 neuts - UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway', 'stats': [{'groupId': 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'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Scrotum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Trachea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils - Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-peri', 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{'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Upper airway NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Urinary tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with unknown ANC - Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'CPK (creatine phosphokinase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac troponin I (cTnI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac troponin T (cTnT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fibrinogen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'INR (of prothrombin time)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 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'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Prolonged QTc interval', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acidosis (metabolic or respiratory)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-low (hypoglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Magnesium, serum-high (hypermagnesemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Phosphate, serum-low (hypophosphatemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-high (hyperkalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Joint-effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle weakness, not d/t neuropathy - Extrem-lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle weakness, not d/t neuropathy - body/general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal/Soft Tissue-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Osteonecrosis (avascular necrosis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Chest wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death - Disease progression 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1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, CNS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: CN III Pupil, eyelid, xtra ocular mvmt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: CN VII Motor-face; Sensory-taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: cranial - CN VI Lateral deviation of e', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Somnolence/depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Speech impairment (e.g., dysphasia or aphasia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope (fainting)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Taste alteration (dysgeusia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vasovagal episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Personality/behavioral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Psychosis (hallucinations/delusions)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, GU - Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, GU - Urinary NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, GU - Ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, GU - Urethra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/Genitourinary-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary retention (including neurogenic bladder)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Testicle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Adult respiratory distress syndrome (ARDS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema, larynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, Respiratory tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, pulmonary/upper respiratory - Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pleural effusion (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary fibrosis (radiographic changes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatology/Skin-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Induration/fibrosis (skin and subcutaneous tissue)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Scalp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 492, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '496', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '20.1'}, {'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '19.8'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.19', 'groupDescription': 'The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 18.0 months to 22.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 7 years after study opens', 'description': 'Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '496', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '10.2'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '9.9'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.16', 'groupDescription': 'The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 6.0 months to 7.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 7 years after study opens', 'description': 'Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compare Pain Progression Between the Two Study Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those patients who progressed on study were included in this analysis. The proportion of patients with pain progression is calculated using number of patients with pain progression as the numerator and the total number of patients who progressed on study as the denominator.'}, {'type': 'SECONDARY', 'title': 'Compare Qualitative and Quantitative Toxicity Between the Two Study Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.'}], 'classes': [{'title': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'AST, SGOT', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Adult respiratory distress syndrome (ARDS)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, serum-low (hypoalbuminemia)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Allergic reaction/hypersensitivity', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Allergy/Immunology-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Amylase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Arthritis (non-septic)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspiration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Auditory/Ear-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (hyperbilirubinemia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood/Bone Marrow-Other (Specify)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CNS cerebrovascular ischemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'CPK (creatine phosphokinase)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, serum-low (hypocalcemia)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Arrhythmia-Other (Specify)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac General-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac troponin I (cTnI)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac troponin T (cTnT)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac-ischemia/infarction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Conduction abnormality NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Confusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dry mouth/salivary gland (xerostomia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia (difficulty swallowing)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea (shortness of breath)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Edema: head and neck', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Edema: limb', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Edema: trunk/genital', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erectile dysfunction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Esophagitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue (asthenia, lethargy, malaise)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, serum-high (hyperglycemia)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, serum-low (hypoglycemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heartburn/dyspepsia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Hemolysis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhage, Respiratory tract NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhage, GI - Rectum', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhage, GI - Stomach', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhage, GI - Upper GI NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhage, GU - Bladder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhage/Bleeding-Other (Specify)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhoids', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hot flashes/flushes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hypoxia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'INR (of prothrombin time)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Induration/fibrosis (skin and subcutaneous tissue)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Bladder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Blood', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Lung', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Nerve-periph', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Skin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - UTI', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Blood', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Colon', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Lung', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Muscle', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Scrotum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Sinus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Skin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Stomach', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Trachea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - UTI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/normal ANC or Gr 1-2 neutrophils - Ungual', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/unknown ANC - Middle ear (otitis media)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inf w/unknown ANC - Upper aerodigestive NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infection with unknown ANC - Blood', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infection with unknown ANC - Lung (pneumonia)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Infection with unknown ANC - Upper airway NOS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infection with unknown ANC - Urinary tract NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infection-Other (Specify)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Left ventricular diastolic dysfunction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Left ventricular systolic dysfunction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (total WBC)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Lipase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium, serum-high (hypermagnesemia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metabolic/Laboratory-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Mood alteration - agitation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mood alteration - depression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Mucositis/stomatitis (clinical exam) - Pharynx', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mucositis/stomatitis (clinical exam) - Stomach', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mucositis/stomatitis (functional/symp) - Esophagus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mucositis/stomatitis (functional/symp) - Oral cav', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Mucositis/stomatitis (functional/symp) - Pharynx', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mucositis/stomatitis (functional/symp) - Rectum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - Extrem-lower', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscle weakness, not d/t neuropathy - body/general', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Myocarditis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nail changes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nasal cavity/paranasal sinus reactions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Neuropathy: motor', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Neuropathy: sensory', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils/granulocytes (ANC/AGC)', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Opportunistic inf associated w/gt=Gr 2 lymphopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PTT (Partial thromboplastin time)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Abdomen NOS', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Back', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Bone', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Chest wall', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Chest/thorax NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Extremity-limb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Joint', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Muscle', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Neuralgia/peripheral nerve', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain - Pelvis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pain-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate, serum-low (hypophosphatemia)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonitis/pulmonary infiltrates', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pneumothorax', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, serum-high (hyperkalemia)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, serum-low (hypokalemia)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary/Upper Respiratory-Other (Specify)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rash: hand-foot skin reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal failure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Renal/Genitourinary-Other (Specify)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Right ventricular dysfunction (cor pulmonale)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SVT and nodal arrhythmia - Atrial fibrillation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'SVT and nodal arrhythmia - Atrial flutter', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SVT and nodal arrhythmia - Sinus tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, serum-low (hyponatremia)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence/depressed level of consciousness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Speech impairment (e.g., dysphasia or aphasia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sudden death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Syncope (fainting)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis/embolism (vascular access-related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Thrombosis/thrombus/embolism', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Vasovagal episode', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Watery eye (epiphora, tearing)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Weight gain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every 3 weeks up to 52 weeks', 'description': 'Only adverse events that are possibly, probably or definitely related to study drug are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo'}, {'type': 'SECONDARY', 'title': 'Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '496', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 years after study opens', 'description': 'PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'classes': [{'categories': [{'title': 'Partial response (confirmed)', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Complete response', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No response', 'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '450 (225 in each arm) of 461 patients with measurable disease at trial enrollment were assessable for response by RECIST.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 18 months study period', 'description': 'Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of "0" will be defined as "stable" if their WPS remains "0" for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There was a large amount of missing data points due to the difficulty of data collection of pain medication logs in addition to a questionnaire.The study team and site staff were only able to obtain complete data for the patients included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With a Change in Functional Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'OG001', 'title': 'Arm II: Atrasentan Hydrochloride', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 18 months study period', 'description': 'Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'FG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '518'}, {'groupId': 'FG001', 'numSubjects': '520'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '496'}, {'groupId': 'FG001', 'numSubjects': '500'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Not eligible for assigned treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}, {'title': 'Eligible for Protocol Assigned Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '496'}, {'groupId': 'FG001', 'numSubjects': '500'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '327'}, {'groupId': 'FG001', 'numSubjects': '315'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '56'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '496', 'groupId': 'BG000'}, {'value': '498', 'groupId': 'BG001'}, {'value': '994', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I: Placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally\n\nplacebo: Given orally'}, {'id': 'BG001', 'title': 'Arm II: Atrasentan', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.\n\natrasentan hydrochloride: Given orally\n\ndocetaxel: Docetaxel given IV and prednisone given orally\n\nprednisone: Docetaxel given IV and prednisone given orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '89'}, {'value': '69', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '92'}, {'value': '69', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '496', 'groupId': 'BG000'}, {'value': '498', 'groupId': 'BG001'}, {'value': '994', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '476', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '953', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '806', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Serum PSA', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'groupId': 'BG000', 'lowerLimit': '24.6', 'upperLimit': '202.4'}, {'value': '79.0', 'groupId': 'BG001', 'lowerLimit': '23.5', 'upperLimit': '228.3'}, {'value': '72.7', 'groupId': 'BG002', 'lowerLimit': '24.4', 'upperLimit': '213.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ug/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Type of Progression at study entry', 'classes': [{'categories': [{'title': 'Measurable or evaluable', 'measurements': [{'value': '394', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}, {'title': 'PSA increase only', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bisphosphonate use at study entry', 'classes': [{'categories': [{'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '609', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Brief Pain Inventory, worst pain', 'classes': [{'categories': [{'title': '>= 4', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}]}, {'title': '<4', 'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '571', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'score \\>=4 vs \\<4 in the Brief Pain Inventory scale for worst pain', 'unitOfMeasure': 'Participants'}, {'title': 'Metastases', 'classes': [{'categories': [{'title': 'Skeletal only', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'Lymph nodes', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': 'Lung, liver or brain', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Extraskeletal', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous prostatectomy', 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Performance status', 'classes': [{'categories': [{'title': '2-3', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': '0-1', 'measurements': [{'value': '457', 'groupId': 'BG000'}, {'value': '462', 'groupId': 'BG001'}, {'value': '919', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'SWOG Performance status:\n\n0 = Fully active, able to carry on all pre-disease performance without restriction.\n\n1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.\n2. = Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.\n3. = Capable of limited self-care, confined to bed or chair more than 50% of waking hours.', 'unitOfMeasure': 'Participants'}, {'title': 'Gleason score', 'classes': [{'categories': [{'title': '5-6', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': '7', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': '8-10', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '547', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Pathologists grade prostate cancers using numbers from 1 to 5 based on how much the cells in the cancerous tissue look like normal tissue. This is called the Gleason system.\n\nIf the cancerous tissue looks like normal tissue, a grade of 1 is assigned. If the cancer cells look very abnormal, a grade of 5 is assigned. Grades 2-4 have features in between these extremes.\n\nSince prostate cancers often have areas with different grades, a grade is assigned to the 2 areas that make up most of the cancer. These 2 grades are added to yield the Gleason score. The highest a Gleason score can be is 10.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 1038 patients were randomized to this study, 42 of which were ineligible. Baseline analysis population includes 994 patients (excluding the 42 ineligible patients and 2 additional patients who withdrew all consent prior to receiving protocol treatment).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1038}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2005-08-22', 'resultsFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2005-08-22', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-21', 'studyFirstPostDateStruct': {'date': '2005-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)', 'timeFrame': 'up to 18 months study period', 'description': 'Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of "0" will be defined as "stable" if their WPS remains "0" for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment'}, {'measure': 'Number of Patients With a Change in Functional Status', 'timeFrame': 'up to 18 months study period', 'description': 'Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment.'}], 'primaryOutcomes': [{'measure': 'Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.', 'timeFrame': 'Up to 7 years after study opens', 'description': 'Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.'}, {'measure': 'Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.', 'timeFrame': 'Up to 7 years after study opens', 'description': 'Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression.'}], 'secondaryOutcomes': [{'measure': 'Compare Pain Progression Between the Two Study Arms.', 'timeFrame': 'Up to 52 weeks', 'description': 'Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization.'}, {'measure': 'Compare Qualitative and Quantitative Toxicity Between the Two Study Arms', 'timeFrame': 'Assessed every 3 weeks up to 52 weeks', 'description': 'Only adverse events that are possibly, probably or definitely related to study drug are reported.'}, {'measure': 'Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.', 'timeFrame': 'Up to 7 years after study opens', 'description': 'PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression.'}, {'measure': 'Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.', 'timeFrame': 'Up to 52 weeks', 'description': 'Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage IV prostate cancer', 'recurrent prostate cancer', 'bone metastases'], 'conditions': ['Metastatic Cancer', 'Prostate Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Goldkorn A, Ely B, Quinn DI, et al.: Results of telomerase activity measurements from live circulating tumor cells captured on a slot microfilter in a phase III SWOG-coordinated prostate cancer trial (S0421). [Abstract] J Clin Oncol 30 (Suppl 15): A-4663, 2012.'}, {'type': 'RESULT', 'citation': 'Lara P, Ely B, Quinn DI, et al.: SWOG 0421: prognostic and predictive value of bone metabolism biomarkers (BMB) in castration resistant prostate cancer (CRPC) patients (pts) with skeletal metastases treated with docetaxel (DOC) with or without atrasentan (ATR). [Abstract] J Clin Oncol 30 (Suppl 15): A-4547, 2012.'}, {'type': 'RESULT', 'citation': 'Quinn DI, Tangen CM, Hussain M, et al.: SWOG S0421: phase III study of docetaxel (D) and atrasentan (A) versus docetaxel and placebo (P) for men with advanced castrate resistant prostate cancer (CRPC). [Abstract] J Clin Oncol 30 (Suppl 15): A-4511, 2012.'}, {'pmid': '24616308', 'type': 'RESULT', 'citation': 'Goldkorn A, Ely B, Quinn DI, Tangen CM, Fink LM, Xu T, Twardowski P, Van Veldhuizen PJ, Agarwal N, Carducci MA, Monk JP 3rd, Datar RH, Garzotto M, Mack PC, Lara P Jr, Higano CS, Hussain M, Thompson IM Jr, Cote RJ, Vogelzang NJ. Circulating tumor cell counts are prognostic of overall survival in SWOG S0421: a phase III trial of docetaxel with or without atrasentan for metastatic castration-resistant prostate cancer. J Clin Oncol. 2014 Apr 10;32(11):1136-42. doi: 10.1200/JCO.2013.51.7417. Epub 2014 Mar 10.'}, {'type': 'RESULT', 'citation': 'Goldkorn A, Xu T, Lu B, et al.: Circulating tumor cell capture and analysis in a multicenter SWOG-coordinated prostate cancer trial. [Abstract] J Clin Oncol 28 (Suppl 15): A-TPS342, 2010.'}, {'pmid': '24565955', 'type': 'DERIVED', 'citation': 'Lara PN Jr, Ely B, Quinn DI, Mack PC, Tangen C, Gertz E, Twardowski PW, Goldkorn A, Hussain M, Vogelzang NJ, Thompson IM, Van Loan MD. Serum biomarkers of bone metabolism in castration-resistant prostate cancer patients with skeletal metastases: results from SWOG 0421. J Natl Cancer Inst. 2014 Apr;106(4):dju013. doi: 10.1093/jnci/dju013. Epub 2014 Feb 24.'}, {'pmid': '23871417', 'type': 'DERIVED', 'citation': 'Quinn DI, Tangen CM, Hussain M, Lara PN Jr, Goldkorn A, Moinpour CM, Garzotto MG, Mack PC, Carducci MA, Monk JP, Twardowski PW, Van Veldhuizen PJ, Agarwal N, Higano CS, Vogelzang NJ, Thompson IM Jr. Docetaxel and atrasentan versus docetaxel and placebo for men with advanced castration-resistant prostate cancer (SWOG S0421): a randomised phase 3 trial. Lancet Oncol. 2013 Aug;14(9):893-900. doi: 10.1016/S1470-2045(13)70294-8. Epub 2013 Jul 17.'}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer.\n\nPURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the survival and progression-free survival of patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo.\n\nSecondary\n\n* Compare pain progression of patients treated with these regimens.\n* Compare the qualitative and quantitative toxicity of these regimens in these patients.\n* Compare the quality of life, in terms of palliation of metastatic bone pain and improvement in functional status, of patients treated with these regimens.\n* Compare prostate-specific antigen (PSA) response rates in patients treated with these regimens.\n* Compare objective response in patients with measurable disease treated with these regimens.\n* Determine whether a 30% reduction in PSA and the slope of PSA from baseline to 3 months is a surrogate marker for survival in patients treated with these regimens.\n* Correlate PSA progression with clinical progression and death in patients treated with these regimens.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease progression (measurable or non-measurable disease progression vs prostate-specific antigen progression only), use of bisphosphonates at study entry (yes vs no), worst pain, measured by the Brief Pain Inventory "pain" scale (\\< grade 4 vs ≥ grade 4), and extraskeletal metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks in the absence of disease progression\\* or unacceptable toxicity.\n* Arm II: Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks in the absence of disease progression\\* or unacceptable toxicity.\n\nNOTE: \\*Patients with PSA progression alone will be allowed to continue treatment\n\nQuality of life is assessed at baseline, before courses 4, 7, and 10, and then after completion of study treatment.\n\nAfter completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years from study entry.\n\nPROJECTED ACCRUAL: A total of 930 patients will be accrued for this study within 4 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n\n * Stage IV disease (any T, any N, M1b)\n\n * Evidence of bone metastases by bone scan or MRI\n* Measurable or nonmeasurable disease\n\n * Soft tissue disease that has been irradiated within the past 2 months is not assessable as measurable disease\n* Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria:\n\n * Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels\\* taken ≥ 1 week apart\n\n * PSA ≥ 5 ng/mL NOTE: \\*If the third confirmatory PSA level is \\< the second level, the patient is considered eligible provided a fourth PSA level is \\> the second level\n * Progression of measurable disease\n * Progression of nonmeasurable disease by bone scan\n* Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone \\[LHRH\\] agonist \\[e.g., leuprolide or goserelin\\] or LHRH antagonist therapy) castration\n\n * Patients who have undergone medical castration must continue LHRH agonist or antagonist therapy during study treatment\n* Must have completed 12 courses of blinding protocol treatment (atrasentan/placebo) AND stopped docetaxel for any reason (including completion of 12 courses) other than progressive disease\n* No symptomatic pleural effusion\n* No third space fluid accumulation (e.g., ascites)\n* No prior or concurrent brain metastases\n\n * Patients with clinical evidence of brain metastases must have a negative brain CT scan or MRI within the past 8 weeks\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-3\\* NOTE: For a performance status of 3, the cause must be due to pain secondary to bone metastases\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* Fertile patients must use effective contraception\n* Able to take oral medication without crushing, dissolving, or chewing tablets\n* No major infection\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission\n* No symptomatic sensory neuropathy ≥ grade 2\n* No history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80\n* No other significant, active medical illness that would preclude study treatment or survival\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No more than 1 prior systemic vaccine or biologic therapy\n\n * At least 4 weeks since prior vaccine or biologic therapy and recovered\n* No concurrent biological response modifiers\n* No concurrent prophylactic colony-stimulating factors\n\nChemotherapy\n\n* More than 2 years since prior adjuvant therapy with a single non-taxane-containing cytotoxic regimen\n* No prior cytotoxic chemotherapy for metastatic prostate cancer\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* At least 6 weeks since prior bicalutamide or nilutamide AND has subsequent disease progression\n* At least 4 weeks since prior flutamide or ketoconazole AND has subsequent disease progression\n* Prior or concurrent megestrol for treatment of hot flashes allowed\n* No other concurrent corticosteroid or hormonal therapy unless continuing luteinizing hormone-releasing hormone treatment and/or bisphosphonate therapy\n\nRadiotherapy\n\n* See Disease Characteristics\n* Prior samarium allowed\n* At least 3 weeks since prior radiotherapy and recovered\n* No prior radiotherapy to ≥ 30% of the bone marrow\n* No prior strontium\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* At least 3 weeks since prior surgery and recovered\n\nOther\n\n* More than 4 weeks since prior investigational drugs\n* Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression\n\n * No initiation of bisphosphonates during the first 12 weeks of study treatment\n* No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum \\[St. John's wort\\])\n\n * Concurrent daily vitamins and calcium supplements allowed\n* At least 14 days since prior and no concurrent administration of any of the following:\n\n * Antibiotics (e.g., clarithromycin, erythromycin, troleandomycin, rifampin, rifabutin, and rifapentine)\n * Antifungals (e.g., itraconazole, ketoconazole, fluconazole \\[doses \\> 200 mg/day\\], and voriconazole)\n * Antidepressants (e.g., nefazodone and fluvoxamine)\n * Calcium channel blockers (e.g., verapamil, diltiazem)\n * Miscellaneous (e.g., amiodarone \\[no use within 6 months prior to study entry\\], grapefruit juice, bitter orange, or modafinil)\n * Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, and oxcarbazepine)\n * Antibiotics (e.g., rifampin, rifabutin, and rifapentine)"}, 'identificationModule': {'nctId': 'NCT00134056', 'briefTitle': 'S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000439434'}, 'secondaryIdInfos': [{'id': 'S0421', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I: placebo', 'description': 'Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.', 'interventionNames': ['Drug: docetaxel', 'Drug: prednisone', 'Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II: atrasentan hydrochloride', 'description': 'Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.', 'interventionNames': ['Drug: atrasentan hydrochloride', 'Drug: docetaxel', 'Drug: prednisone']}], 'interventions': [{'name': 'atrasentan hydrochloride', 'type': 'DRUG', 'otherNames': ['atrasentan'], 'description': 'Given orally', 'armGroupLabels': ['Arm II: atrasentan hydrochloride']}, {'name': 'docetaxel', 'type': 'DRUG', 'otherNames': ['taxotere'], 'description': 'Docetaxel given IV and prednisone given orally', 'armGroupLabels': ['Arm I: placebo', 'Arm II: atrasentan hydrochloride']}, {'name': 'prednisone', 'type': 'DRUG', 'otherNames': ['steroid'], 'description': 'Docetaxel given IV and prednisone given orally', 'armGroupLabels': ['Arm I: placebo', 'Arm II: atrasentan hydrochloride']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally', 'armGroupLabels': ['Arm I: placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Providence Cancer Center at Providence Hospital', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Regional Hospital Cancer Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99701', 'city': 'Fairbanks', 'state': 'Alaska', 'country': 'United States', 'facility': 'Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital', 'geoPoint': {'lat': 64.83778, 'lon': -147.71639}}, {'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Hembree Mercy Cancer Center at St. Edward Mercy Medical Center', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Radiation Oncology Center', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Eden Medical Center', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Valley Medical Oncology Consultants - 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Division of Ortho Biotech Products, LP', 'geoPoint': {'lat': 39.14573, 'lon': -121.59135}}, {'zip': '93940', 'city': 'Monterey', 'state': 'California', 'country': 'United States', 'facility': 'Community Hospital of the Monterey Peninsula Comprehensive Cancer Center', 'geoPoint': {'lat': 36.60024, 'lon': -121.89468}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Camino Medical Group - Treatment Center', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Hospital Cancer Center', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94602', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Highland General Hospital', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - 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