Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT01835158
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2013-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
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': 'C558660', 'term': 'cabozantinib'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'toni_choueiri@dfci.harvard.edu', 'phone': '(617) 632-5456', 'title': 'Toni K. Choueiri, MD', 'organization': 'Harvard'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Cabozantinib-s-malate)', 'description': 'Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 78, 'otherNumAffected': 76, 'seriousNumAtRisk': 78, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Arm II (Sunitinib Malate)', 'description': 'Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 72, 'otherNumAffected': 68, 'seriousNumAtRisk': 72, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 94, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 103, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Blood and lymph sys disorders - Oth Spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Ear and labyrinth disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Endocrine disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 50, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 27, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Anal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Colonic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 29, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 305, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 96, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 69, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 56, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 23, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Fecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 26, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 23, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gastrointestinal disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 15, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 63, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 50, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 77, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 40, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Oral dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Oral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 38, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 414, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 215, 'numAffected': 58}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 1}, 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'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Sudden death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Metabolism, nutrition disord - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Neoplasms benign, mal, uncpec - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Facial muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypoglossal nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Nervous system disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Renal and urinary disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Palmar-plantar erythrodysesthesia syndrm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Vascular disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cabozantinib-s-malate)', 'description': 'Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm II (Sunitinib Malate)', 'description': 'Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '8.8'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '8.1'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '.46', 'ciUpperLimit': '.95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled on to study.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cabozantinib-s-malate)', 'description': 'Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm II (Sunitinib Malate)', 'description': 'Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '35.0'}, {'value': '21.8', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '27.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.26', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Objective Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cabozantinib-s-malate)', 'description': 'Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Arm II (Sunitinib Malate)', 'description': 'Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.44'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.054', 'upperLimit': '0.21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Cabozantinib-s-malate)', 'description': 'Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'Arm II (Sunitinib Malate)', 'description': 'Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Cabozantinib-s-malate)', 'description': 'Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Arm II (Sunitinib Malate)', 'description': 'Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '82'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '87'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2013-04-16', 'resultsFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2013-04-16', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-20', 'studyFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 5 years', 'description': 'Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 5 years', 'description': 'The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rates', 'timeFrame': 'Up to 5 years', 'description': 'Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clear Cell Renal Cell Carcinoma', 'Metastatic Kidney Carcinoma', 'Stage III Renal Cell Cancer AJCC v7', 'Stage IV Renal Cell Cancer AJCC v7']}, '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': '31399500', 'type': 'DERIVED', 'citation': 'George DJ, Hessel C, Halabi S, Michaelson MD, Hahn O, Walsh M, Picus J, Small EJ, Dakhil S, Feldman DR, Mangeshkar M, Scheffold C, Morris MJ, Choueiri TK. Cabozantinib Versus Sunitinib for Untreated Patients with Advanced Renal Cell Carcinoma of Intermediate or Poor Risk: Subgroup Analysis of the Alliance A031203 CABOSUN trial. Oncologist. 2019 Nov;24(11):1497-1501. doi: 10.1634/theoncologist.2019-0316. Epub 2019 Aug 9.'}, {'pmid': '31371341', 'type': 'DERIVED', 'citation': 'Flaifel A, Xie W, Braun DA, Ficial M, Bakouny Z, Nassar AH, Jennings RB, Escudier B, George DJ, Motzer RJ, Morris MJ, Powles T, Wang E, Huang Y, Freeman GJ, Choueiri TK, Signoretti S. PD-L1 Expression and Clinical Outcomes to Cabozantinib, Everolimus, and Sunitinib in Patients with Metastatic Renal Cell Carcinoma: Analysis of the Randomized Clinical Trials METEOR and CABOSUN. Clin Cancer Res. 2019 Oct 15;25(20):6080-6088. doi: 10.1158/1078-0432.CCR-19-1135. Epub 2019 Aug 1.'}, {'pmid': '29550566', 'type': 'DERIVED', 'citation': 'Choueiri TK, Hessel C, Halabi S, Sanford B, Michaelson MD, Hahn O, Walsh M, Olencki T, Picus J, Small EJ, Dakhil S, Feldman DR, Mangeshkar M, Scheffold C, George D, Morris MJ. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer. 2018 May;94:115-125. doi: 10.1016/j.ejca.2018.02.012. Epub 2018 Mar 20.'}, {'pmid': '28549224', 'type': 'DERIVED', 'citation': 'Choueiri TK, Halabi S, Morris MJ, George D. Reply to B. Rini et al and S. Buti et al. J Clin Oncol. 2017 Jun 1;35(16):1859-1860. doi: 10.1200/JCO.2017.72.2629. Epub 2017 Mar 6. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine if patients with renal cancer treated with cabozantinib (cabozantinib-s-malate) will have improved progression-free survival compared to patients treated with sunitinib (sunitinib malate).\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether the response rate of patients with renal cancer treated with cabozantinib will be higher when compared with patients treated with sunitinib.\n\nII. To determine whether patients with renal cancer treated with cabozantinib will have an improved overall survival when compared with patients treated with sunitinib.\n\nTERTIARY OBJECTIVES:\n\nI. To determine whether renal cancer patients with high MET expression by immunohistochemistry (IHC) have improvement in progression-free survival compared to patients with low MET expression on both arms of this study.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 6 months for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Renal cell carcinoma with some component of clear cell histology; histologic documentation of metastatic disease is not required\n* Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma (RCC) (equivalent to stage IV RCC, according to American Joint Committee on Cancer \\[AJCC\\] staging)\n* Eligible patients must be intermediate/poor risk, per the International Metastatic Renal Cell Carcinoma (mRCC) Database Consortium (Heng) criteria; patients must therefore have as one or more of the following six factors:\n\n * Time from diagnosis of RCC to systemic treatment \\< 1 year\n\n * Note: systemic treatment refers to the initiation of A031203 protocol treatment\n * Hemoglobin \\< the lower limit of normal (LLN)\n * Corrected calcium \\> the upper limit of normal (ULN)\n * Karnofsky performance status \\< 80%\n * Neutrophil count \\> ULN\n * Platelet count \\> ULN\n* No radiographic evidence of cavitating pulmonary lesion(s)\n* No tumor invading the inferior vena cava (IVC) or superior vena cava (SVC) blood vessels\n* No evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days prior to registration\n* No prior systemic treatment for RCC; supportive therapies such as bisphosphonates (zoledronic acid) or denosumab are permitted\n* Patients must not have had a major surgical procedure or significant traumatic injury within 6 weeks prior to study registration, and must have fully recovered from any such procedure; however, patients who have had a nephrectomy may be enrolled 4 weeks after surgery, providing there are no wound-healing complications; the following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures\n* Radiation:\n\n * To the brain, thoracic cavity, abdomen, or pelvis must be completed at least 90 days before registration;\n * To bone must be completed at least 14 days before registration; and\n * To any other sites must be completed at least 28 days before registration In all cases, there must be complete recovery and no ongoing complications from prior radiation therapy\n* No chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors; patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration\n* Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\>= 2 cm with conventional techniques or as \\>= 1 cm with spiral computed tomography (CT) scan\n* No active brain metastases; patients with treated, stable brain metastases for at least three months are eligible as long as they meet the following criteria:\n\n * Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or CT); (stable dose of anticonvulsants are allowed); treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator \\[LINAC\\], or equivalent) or a combination as deemed appropriate by the treating physician; patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to registration are not eligible\n * Baseline brain imaging (MRI/CT) is required\n* No serious non-healing wound, ulcer, or bone fracture requiring intervention within 28 days prior to registration\n* No arterial thrombotic events within 6 months prior to registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the 6 months prior to registration, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block), significant vascular disease (i.e., aortic aneurysm, history of aortic dissection), or any other arterial thrombotic event are ineligible\n* No history of pulmonary embolism or untreated deep venous thrombosis (DVT) within 6 months prior to registration; note: patients with recent DVT who have been treated with therapeutic anticoagulation with low molecular weight heparin for at least 6 weeks are eligible; patients receiving therapeutic warfarin (\\> 2 mg/day) are not eligible; patients on warfarin may be switched to low molecular weight heparin at the discretion of the treating physician\n* No inadequately controlled hypertension (defined as a blood pressure of \\>= 150 mmHg systolic and/or \\>= 90 mmHg diastolic), or any prior history of hypertensive crisis or hypertensive encephalopathy\n* No New York Heart Association (NYHA) class \\>= 2 congestive heart failure\n* Ejection fraction on echocardiogram (Echo) or multi gated acquisition scan (MUGA) \\> 50%\n* No corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 28 days before randomization; note: if initial QTcF is found to be \\> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =\\< 500 ms, the subject meets eligibility in this regard\n* No history of congenital QT syndrome\n* No unstable cardiac arrhythmia within 6 months prior to registration\n* No evidence of any of the following:\n\n * Clinically-significant gastrointestinal bleeding within 6 months before registration; or\n * Hemoptysis of \\>= 0.5 teaspoon (2.5 mL) of red blood within 3 months before registration; or\n * Any other signs indicative of pulmonary hemorrhage within 3 months before registration\n* No history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 6 months prior to registration and complete healing/resolution prior to registration; no percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to registration\n* No active peptic ulcer disease, within 28 days before registration\n* No inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis within 28 days before registration\n* No malabsorption syndrome within 28 days before registration\n* No uncompensated hypothyroidism; patients with hypothyroidism on therapy are required to have thyroid stimulating hormone (TSH) within normal limits\n* No radiologic or clinical evidence of pancreatitis\n* No history of organ transplant\n* Patients with active infection requiring systemic treatment within 28 days prior to registration are not eligible\n* Patients who are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test within 16 days prior to registration; women of child-bearing potential include:\n\n * Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\>= 12 consecutive months)\n * Women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \\> 35m IU/mL\n * Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy)\n* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2\n* Archival tissue must be available for submission, though it is optional for patients to choose to participate in the correlative sub studies\n* Absolute neutrophil count (ANC) \\>= 1,500/uL\n* Platelet count \\>= 100,000/uL\n* Hemoglobin \\>= 9 g/dL; patients may not have had a transfusion within 7 days prior to screening assessment\n* Total bilirubin =\\< 1.5 x upper limits of normal\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\\< 2.5 x ULN\n* Albumin \\>= 2.8 g/dL\n* Serum creatinine =\\< 1.5 x ULN, OR calculated creatinine clearance \\>= 30 mL/minute (modified Cockcroft and Gault formula)\n* Urine protein to creatinine (UPC) ratio \\< 1.0; if UPC \\>= 1, then a 24-hour urine protein must be assessed; eligible patients must have a 24-hour urine protein value \\< 1 g\n* Total serum calcium \\< 12 mg/dL\n* International normalized ratio (INR) =\\< 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation\n* TSH within normal limits (WNL); TSH only required for patients on thyroid supplementation"}, 'identificationModule': {'nctId': 'NCT01835158', 'briefTitle': 'Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Phase II Study Comparing Cabozantinib (NSC #761968) With Commercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'NCI-2013-00820'}, 'secondaryIdInfos': [{'id': 'NCI-2013-00820', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'A031203'}, {'id': 'A031203', 'type': 'OTHER', 'domain': 'Alliance for Clinical Trials in Oncology'}, {'id': 'A031203', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180821', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180821', 'type': 'NIH'}, {'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (cabozantinib-s-malate)', 'description': 'Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cabozantinib S-malate', 'Other: Laboratory Biomarker Analysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (sunitinib malate)', 'description': 'Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Sunitinib Malate']}], 'interventions': [{'name': 'Cabozantinib S-malate', 'type': 'DRUG', 'otherNames': ['BMS-907351', 'Cabometyx', 'Cometriq', 'XL-184', 'XL184'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (cabozantinib-s-malate)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (cabozantinib-s-malate)', 'Arm II (sunitinib malate)']}, {'name': 'Sunitinib Malate', 'type': 'DRUG', 'otherNames': ['SU011248', 'SU11248', 'sunitinib', 'Sutent'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (sunitinib malate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center PC-Providence', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Breast Care and Surgery LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': "Alaska Women's Cancer Care", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Anchorage Oncology Centre', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Katmai Oncology Group', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center/Disney Family Cancer Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '93611', 'city': 'Clovis', 'state': 'California', 'country': 'United States', 'facility': 'Community Cancer Institute', 'geoPoint': {'lat': 36.82523, 'lon': -119.70292}}, {'zip': '93611', 'city': 'Clovis', 'state': 'California', 'country': 'United States', 'facility': 'University Oncology Associates', 'geoPoint': {'lat': 36.82523, 'lon': -119.70292}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego VA Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Mount Zion', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Medical Center of Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose-Saint Francis Healthcare', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Penrose', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Presbyterian - Saint Lukes Medical Center - Health One', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers-Midtown', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 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