Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00586105
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2007-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], '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': 'D007680', 'term': 'Kidney 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': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The median for ´Overall Survival (OS)´ and the median for ´Overall Response Duration´ reported are the median of each distribution including the censored data. The correct estimates of these medians were not evaluable.'}}, 'adverseEventsModule': {'timeFrame': 'From First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV).', 'description': 'Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Partial Thromboplastin Time (PTT), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)', 'eventGroups': [{'id': 'EG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)', 'otherNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'PTT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Edema: Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Supraventricular Arrhythmia, Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Mucositis (Functional/Symptomatic), Oral Cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Mucositis (Clinical Exam), Oral Cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'GI - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Periodontal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Chest/Thorax NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Chest Wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Dental/Teeth/Peridontal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Extremity - Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Head/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Flu-Like Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Infection With Normal ANC, Urinary Tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Infection With Unknown ANC, Skin (Cellulitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Alkaline Phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Amylase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Bilirubin (Hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Lipase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Metabolic/Lab - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Incontinence, Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Nasal/Paranasal Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Dyspnea (Shortness Of Breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Voice Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hand-Foot Skin Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Rash/Desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}], 'seriousEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Obstruction, GI, Small Bowel NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pain, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'No Code In CTCAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Infection With Normal ANC, Biliary Tree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Infection With Normal ANC, Paranasal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Infection With Normal ANC, Urinary Tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Infection With Unknown ANC, Skin (Cellulitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Pulmonary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hand-Foot Skin Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hemorrhage, GI, Duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hemorrhage - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hemorrhage Pulmonary, Bronchus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}, {'term': 'Hemorrhage, GU, Urinary NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC 3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'title': 'AUC (0-12h)', 'categories': [{'measurements': [{'value': '35.5', 'spread': '16.1', 'groupId': 'OG000'}]}]}, {'title': 'AUC norm', 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after at least 21 days of uninterrupted dosing', 'description': 'The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose \\[mg\\]/weight \\[kg\\]).', 'unitOfMeasure': 'mg*hour/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'title': 'Cmax', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Cmin', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after at least 21 days of uninterrupted dosing', 'description': 'Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'title': 'Cmax norm', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Cmin norm', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after at least 21 days of uninterrupted dosing', 'description': 'Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by \\[dose (mg)/weight (kg)\\].', 'unitOfMeasure': 'Kg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months', 'description': 'Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of drug (the intent to treat \\[ITT\\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '13.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from start of therapy to death up to 17.25 months', 'description': 'Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of drug (the intent to treat \\[ITT\\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months', 'description': 'Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of drug (the intent to treat \\[ITT\\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.'}, {'type': 'SECONDARY', 'title': 'Disease Control (DC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'title': 'disease control', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'no disease control', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'not evaluated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start to end of study medication up to 17.25 months', 'description': 'The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of drug (the intent to treat \\[ITT\\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.'}, {'type': 'SECONDARY', 'title': 'Overall Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'not evaluated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Best response observed from start to end of study medication up to 17.25 months', 'description': 'The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of drug (the intent to treat \\[ITT\\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.'}, {'type': 'SECONDARY', 'title': 'Overall Response Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '12.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From PR or CR to progression or death up to 17.25 months', 'description': 'Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of drug (the intent to treat \\[ITT\\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR.'}, {'type': 'SECONDARY', 'title': 'Time to Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '18.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from start of study medication to first documented PR or CR up to 17.25 months', 'description': 'Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of drug (the intent to treat \\[ITT\\] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Switched to commercial drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Reason not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were outpatients with histologically or cytologically confirmed, unresectable and/or metastatic, measurable clear Renal Cell Carcinoma (RCC) who had received not more than one prior systemic therapy. They were enrolled between 29 Dec 2005 and 29 Sep 2006 at 4 centers in China and 4 in Taiwan.', 'preAssignmentDetails': 'A total of 51 Asian subjects were enrolled in the trial. Twelve failed screening (11 protocol violations, 1 adverse event); the remaining 39 received at least 1 dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '14.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Scale', 'classes': [{'title': 'ECOG 0', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'ECOG 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study must have had an ECOG score of 0 or 1 (restricted in physically strenuous activity but ambulatory).', 'unitOfMeasure': 'participants'}, {'title': 'Motzer risk factors', 'classes': [{'title': 'Low-risk (no risk factors)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate-risk (1 or 2 risk factors)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The 5 Motzer risk factors correlate with overall survival in metastatic RCC. Patients with no factors (low-risk) have a favorable survival risk, patients with 1 or 2 risk factors survive a shorter time and constitute an intermediate-risk group, and those with 3 or more risk factors have the poorest survival and represent a poor-risk group.', 'unitOfMeasure': 'participants'}, {'title': 'Renal Cell Carcinoma subtype', 'classes': [{'title': 'Clear cell', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Predominantly clear cell', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients were categorized into 1 or 2 subgroups depending on the tumor histology: Clear cell or predominantly clear cell.', 'unitOfMeasure': 'participants'}, {'title': 'Time since first progression', 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Time since first progression was defined as the time from the first progression of the patient's disease after initial diagnosis until randomization into this study.", 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since initial diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Time since initial diagnosis was the mean time from initial diagnosis to randomization into the study.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-25', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2008-01-03', 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-10', 'studyFirstPostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])', 'timeFrame': '12 hours after at least 21 days of uninterrupted dosing', 'description': 'The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose \\[mg\\]/weight \\[kg\\]).'}, {'measure': 'Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)', 'timeFrame': '12 hours after at least 21 days of uninterrupted dosing', 'description': 'Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.'}, {'measure': 'Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)', 'timeFrame': '12 hours after at least 21 days of uninterrupted dosing', 'description': 'Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by \\[dose (mg)/weight (kg)\\].'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months', 'description': 'Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Time from start of therapy to death up to 17.25 months', 'description': 'Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months', 'description': 'Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.'}, {'measure': 'Disease Control (DC)', 'timeFrame': 'From start to end of study medication up to 17.25 months', 'description': 'The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).'}, {'measure': 'Overall Best Response', 'timeFrame': 'Best response observed from start to end of study medication up to 17.25 months', 'description': 'The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.'}, {'measure': 'Overall Response Duration', 'timeFrame': 'From PR or CR to progression or death up to 17.25 months', 'description': 'Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.'}, {'measure': 'Time to Objective Response', 'timeFrame': 'Time from start of study medication to first documented PR or CR up to 17.25 months', 'description': 'Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sorafenib', 'Nexavar', 'Metastatic RCC', 'Renal Cell Carcinoma', 'Unresectable RCC'], 'conditions': ['Carcinoma, Renal Cell']}, 'descriptionModule': {'briefSummary': 'A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have a life expectancy of at least 12 weeks\n* Patients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients with rare subtypes of RCC such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors are excluded from study participation.\n* Patients who have received not more than one prior systemic therapy for advanced disease which was completed at least 30 days prior to the first dose of study medication.\n* Patients who have at least one uni-dimensional measurable lesion by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST)\n* Patients with "Intermediate" or "low" risk per the Motzer score\n* Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate bone marrow, liver and renal function at screening as assessed by the following:\n* Total bilirubin \\< 1.5 x the upper limit of normal.\n* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\< 2.5 x upper limit of normal (\\< 5 x upper limit of normal for patients with liver involvement of their cancer).\n* Amylase and lipase \\< 1.5 x the upper limit of normal.\n\n * Serum creatinine \\< 2.0 x the upper limit of normal.\n * Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) \\< 1.5 x upper limit of normal\n\nExclusion Criteria:\n\n* Previous or concurrent cancer that is distinct in primary sit or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors \\[Ta (Noninvasive papillary carcinoma), Tis (Carcinoma in situ: "flat tumor") and T1 (Tumor invades subepithelial connective tissue)\\] or any cancer curatively treated \\> 3 years prior to study entry)\n* Patients who completed their prior systemic treatment regimen less than 30 days\n* Cardiac arrhythmias requiring anti-arrhythmic (excluding beta blockers or digoxin), symptomatic coronary artery disease or ischemia\n* Active clinically serious bacterial or fungal infections\n* Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C requiring current interferon treatment\n* Symptomatic metastatic brain or meningeal tumors unless the patient is \\> 6 months from definitive therapy, has a negative imaging studies within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.\n* Patients with evidence or history of bleeding diathesis.\n* Patients with seizure disorder requiring medication\n* History of organ allograft\n* Substance abuse, medical, psychological or social conditions that may interfere with the patient\'s participation in the study or evaluation of the study results\n* Pregnant or breast-feeding patients.\n\nExcluded concomitant medications:\n\n* Concurrent anti-cancer chemotherapy, immunotherapy, or hormonal therapy except Bisphosphonates\n* Radiotherapy during study or within 3 weeks of start of study drug.\n* Biological response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CFS) or Granulocyte macrophage colony-stimulating factor (GM-CFS), within 3 weeks prior to study entry or during study\n* Significant surgery within 4 weeks prior to start of study drug\n* Autologous bone marrow transplant or stem cell rescue within 4 months of study\n* Investigational drug therapy during or within 4 weeks prior to first drug administration and during the study\n* St John\'s Wort\n* Xiao Chai Hu Tang\n* Prior and concomitant use of Bevacizumab, and all other drugs (investigational or licensed) that target Vascular Endothelial Growth Factor (VEGF)/VEGF-Receptors, Raf-kinase inhibitors (RKI), Methyl Ethyl Ketone (MEK) or Farnesyl transferase inhibitors'}, 'identificationModule': {'nctId': 'NCT00586105', 'briefTitle': 'Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter Uncontrolled Study of Sorafenib in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '11559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sorafenib (Nexavar, BAY43-9006)', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)', 'interventionNames': ['Drug: Sorafenib (Nexavar, BAY43-9006)']}], 'interventions': [{'name': 'Sorafenib (Nexavar, BAY43-9006)', 'type': 'DRUG', 'description': '400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)', 'armGroupLabels': ['Sorafenib (Nexavar, BAY43-9006)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210003', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '100021', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '70428', 'city': 'Tainan', 'state': 'Tainan', 'country': 'Taiwan', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}