Viewing Study NCT00065468


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Study NCT ID: NCT00065468
Status: COMPLETED
Last Update Posted: 2012-10-25
First Post: 2003-07-24
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'C401859', 'term': 'temsirolimus'}], 'ancestors': [{'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Efficacy data was not collected or analyzed after the primary analysis was completed.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal', 'otherNumAtRisk': 200, 'otherNumAffected': 197, 'seriousNumAtRisk': 200, 'seriousNumAffected': 99}, {'id': 'EG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal', 'otherNumAtRisk': 208, 'otherNumAffected': 208, 'seriousNumAtRisk': 208, 'seriousNumAffected': 82}, {'id': 'EG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal', 'otherNumAtRisk': 208, 'otherNumAffected': 205, 'seriousNumAtRisk': 208, 'seriousNumAffected': 122}], 'otherEvents': [{'term': 'ASTHENIA', 'notes': 'Body as a whole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 127}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 126}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ALLERGIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 72}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'FACE EDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ACCIDENTAL INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'FLU SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'LAB TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPERTENSION', 'notes': 'Cardiovascular system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'VASODILATATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'NAUSEA', 'notes': 'Digestive system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'MUCOSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'MOUTH ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ORAL MONILIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ANEMIA', 'notes': 'Hemic and Lymphatic system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 123}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 77}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 65}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPERLIPEMIA', 'notes': 'Metabolic and Nutritional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 80}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'PERIPHERAL EDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPERCHOLESTEREMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 55}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPERGLYCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'WEIGHT LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 65}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 42}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPOKALEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'EDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPOPHOSPHATEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'SGOT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 43}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPOPROTEINEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'LACTIC DEHYDROGENASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'SGPT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPOCALCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPERCALCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPERKALEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPONATREMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'BUN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ARTHRALGIA', 'notes': 'Musculoskeletal system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'INSOMNIA', 'notes': 'Nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 18}, 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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 6}], 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208, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HEMORRHAGIC GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HEPATIC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HEPATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 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'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HYPERCALCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 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disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'RESPIRATORY DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'RESPIRATORY DISTRESS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'SKIN CARCINOMA', 'notes': 'Skin and Appendages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'CATARACT SPECIFIED', 'notes': 'Special senses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DIPLOPIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'ACUTE KIDNEY FAILURE', 'notes': 'Urogenital system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'GLOMERULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'KIDNEY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'UREMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'HEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'KIDNEY FUNCTION ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'OLIGURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'URINARY INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'URINARY TRACT DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'DEVICE MALFUNCTION', 'notes': 'Adverse event associated with miscellaneous factors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '8.8'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '12.7'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '6.6', 'upperLimit': '10.3'}]}]}], 'analyses': [{'pValue': '0.0252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.97', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': True, 'nonInferiorityComment': '2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.'}, {'pValue': '0.4902', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': True, 'nonInferiorityComment': '2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Month 80', 'description': 'Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) Population: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.0'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '7.2'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '6.0'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}, {'pValue': '0.0107', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, monthly until tumor progression or death (up to Month 80)', 'description': 'PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '8.4'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '13.0'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '13.5'}]}]}], 'analyses': [{'pValue': '0.1361', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}, {'pValue': '0.1062', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, every 2 months until tumor progression or death (up to Month 80)', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '21.5'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '27.6', 'upperLimit': '40.4'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '23.8', 'upperLimit': '36.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, every 2 months until tumor progression or death (up to Month 80)', 'description': 'Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '18.4'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '13.8'}, {'value': '9.3', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': '23.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, every month until tumor progression or death (up to Month 80)', 'description': 'DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT subset of participants who had a response'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '1.9'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '3.9'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.76', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.89', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by prior nephrectomy and region', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, every month until tumor progression or death (up to Month 80)', 'description': 'TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9083', 'groupId': 'OG000'}, {'value': '8.3707', 'groupId': 'OG001'}, {'value': '7.4821', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 80', 'description': 'The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the "dispersion" of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.', 'unitOfMeasure': 'months', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'European Quality of Life Health Questionnaire (EQ-5D) - Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'OG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'OG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'classes': [{'categories': [{'measurements': [{'value': '0.656', 'groupId': 'OG000', 'lowerLimit': '-0.319', 'upperLimit': '1.000'}, {'value': '0.689', 'groupId': 'OG001', 'lowerLimit': '-0.181', 'upperLimit': '1.000'}, {'value': '0.689', 'groupId': 'OG002', 'lowerLimit': '-0.239', 'upperLimit': '1.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'FG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'FG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 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'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Discontinuation of study by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}, {'value': '626', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Interferon Alfa', 'description': 'Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal'}, {'id': 'BG001', 'title': 'Temsirolimus', 'description': 'Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal'}, {'id': 'BG002', 'title': 'Interferon Alfa and Temsirolimus', 'description': 'Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '59.1', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '432', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 626}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-24', 'studyFirstSubmitDate': '2003-07-24', 'resultsFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2003-07-24', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-24', 'studyFirstPostDateStruct': {'date': '2003-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline up to Month 80', 'description': 'Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline, monthly until tumor progression or death (up to Month 80)', 'description': 'PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Baseline, every 2 months until tumor progression or death (up to Month 80)', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}, {'measure': 'Percentage of Participants With Clinical Benefit', 'timeFrame': 'Baseline, every 2 months until tumor progression or death (up to Month 80)', 'description': 'Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline, every month until tumor progression or death (up to Month 80)', 'description': 'DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'Baseline, every month until tumor progression or death (up to Month 80)', 'description': 'TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.'}, {'measure': 'Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)', 'timeFrame': 'Baseline to Month 80', 'description': 'The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the "dispersion" of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.'}, {'measure': 'European Quality of Life Health Questionnaire (EQ-5D) - Index Score', 'timeFrame': 'Baseline', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced Renal Cell Carcinoma', 'Kidney Cancer'], 'conditions': ['Carcinoma, Renal Cell', 'Kidney Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37146227', 'type': 'DERIVED', 'citation': 'Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.'}, {'pmid': '28410911', 'type': 'DERIVED', 'citation': 'de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.'}, {'pmid': '27238653', 'type': 'DERIVED', 'citation': 'Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.'}, {'pmid': '25577718', 'type': 'DERIVED', 'citation': 'Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.'}, {'pmid': '17538086', 'type': 'DERIVED', 'citation': "Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81. doi: 10.1056/NEJMoa066838."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-304&StudyName=Study%20Evaluating%20Interferon%20And%20CCI-779%20In%20Advanced%20Renal%20Cell%20Carcinoma', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \\[Temsirolimus\\], administered intravenously \\[IV\\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \\[IFN alfa\\] subcutaneously \\[SC\\] three times per week \\[TIW\\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,\n\nExclusion Criteria:\n\n* Subjects with central nervous system (CNS) metastases\n* Prior anticancer therapy for RCC\n* Prior investigational therapy/agents within 4 weeks 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