Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-08 @ 2:07 PM
Study NCT ID:
NCT00555620
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2007-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000077210', 'term': 'Sunitinib'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2', 'description': 'Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.', 'otherNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.', 'otherNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Rectal tenesmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 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{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infectious peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2', 'description': 'Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 21', 'description': 'Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having \\>3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery \\>14 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cmax SU011248', 'categories': [{'measurements': [{'value': '40.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '46.5', 'spread': '10.8', 'groupId': 'OG002'}]}]}, {'title': 'Cmax SU012662', 'categories': [{'measurements': [{'value': '14.0', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '16.6', 'spread': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Cmax total drug (SU011248+SU012662)', 'categories': [{'measurements': [{'value': '53.9', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '62.4', 'spread': '13.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Cmax of CAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. 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CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Tmax SU011248', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '10.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '10.0'}]}]}, {'title': 'Tmax SU012662', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '10.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '24.0'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}, {'title': 'Tmax total drug (SU011248+SU012662)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '10.0'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Tmax for CAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '8.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.0'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '4.0'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.3'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': "Tmax for 5'DFCR", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '8.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.0'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.0'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': "Tmax for 5'DFUR", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '8.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.0'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.0'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Tmax for 5-FU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '8.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '4.0'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.'}, {'type': 'SECONDARY', 'title': 't1/2 for CAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.3', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '0.3', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.4', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '0.5', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': "t1/2 for 5'DFCR", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': "t1/2 for 5'DFUR", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.7', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.6', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': 't1/2 for 5-FU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.8', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '0.6', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'AUC (0-24) SU011248', 'categories': [{'measurements': [{'value': '844', 'spread': '155', 'groupId': 'OG000', 'lowerLimit': '875', 'upperLimit': '829'}, {'value': '1420', 'spread': '379', 'groupId': 'OG001'}, {'value': '902', 'spread': '230', 'groupId': 'OG002'}]}]}, {'title': 'AUC (0-24) SU012662', 'categories': [{'measurements': [{'value': '321', 'spread': '254', 'groupId': 'OG000'}, {'value': '524', 'spread': '219', 'groupId': 'OG001'}, {'value': '327', 'spread': '64', 'groupId': 'OG002'}]}]}, {'title': 'AUC (0-24) total drug (SU011248+SU012662)', 'categories': [{'measurements': [{'value': '1163', 'spread': '407', 'groupId': 'OG000', 'lowerLimit': '875', 'upperLimit': '829'}, {'value': '1944', 'spread': '533', 'groupId': 'OG001'}, {'value': '1230', 'spread': '273', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)', 'description': 'Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.', 'unitOfMeasure': 'nanogram hours per milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data'}, {'type': 'SECONDARY', 'title': "Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'CAP (n = 1, 4, 10)', 'categories': [{'measurements': [{'value': '7480', 'spread': 'NA', 'comment': 'Only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '2828', 'spread': '215', 'groupId': 'OG001'}, {'value': '8069', 'spread': '3877', 'groupId': 'OG002'}]}]}, {'title': "5'DFCR (n = 1, 7, 10)", 'categories': [{'measurements': [{'value': '9200', 'spread': 'NA', 'comment': 'Only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '8853', 'spread': '1648', 'groupId': 'OG001'}, {'value': '11467', 'spread': '2476', 'groupId': 'OG002'}]}]}, {'title': "5'DFUR (n = 1, 6, 10)", 'categories': [{'measurements': [{'value': '7770', 'spread': 'NA', 'comment': 'Only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '5703', 'spread': '1295', 'groupId': 'OG001'}, {'value': '9099', 'spread': '2288', 'groupId': 'OG002'}]}]}, {'title': '5-FU (n = 1, 5, 9)', 'categories': [{'measurements': [{'value': '386', 'spread': 'NA', 'comment': 'Only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '285', 'spread': '119', 'groupId': 'OG001'}, {'value': '489', 'spread': '190', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category'}, {'type': 'SECONDARY', 'title': "Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'CAP (n = 1, 4, 9)', 'categories': [{'measurements': [{'value': '25435', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '2663', 'spread': '452', 'groupId': 'OG001'}, {'value': '8865', 'spread': '6533', 'groupId': 'OG002'}]}]}, {'title': "5'DFCR (n = 1, 7, 10)", 'categories': [{'measurements': [{'value': '15522', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '7087', 'spread': '1222', 'groupId': 'OG001'}, {'value': '10091', 'spread': '2847', 'groupId': 'OG002'}]}]}, {'title': "5'DFUR (n = 1, 6, 10)", 'categories': [{'measurements': [{'value': '15522', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '4822', 'spread': '1222', 'groupId': 'OG001'}, {'value': '10291', 'spread': '3675', 'groupId': 'OG002'}]}]}, {'title': '5-FU (n = 1, 5, 10)', 'categories': [{'measurements': [{'value': '1299', 'spread': 'NA', 'comment': 'only 1 participant evaluated', 'groupId': 'OG000'}, {'value': '353', 'spread': '141', 'groupId': 'OG001'}, {'value': '842', 'spread': '403', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '7555', 'spread': '135', 'groupId': 'OG000'}, {'value': '2899', 'spread': '1580', 'groupId': 'OG001'}, {'value': '7373', 'spread': '4199', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '13532', 'spread': '16648', 'groupId': 'OG000'}, {'value': '3157', 'spread': '1171', 'groupId': 'OG001'}, {'value': '8213', 'spread': '6432', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category'}, {'type': 'SECONDARY', 'title': "AUClast for 5'DFCR", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '12815', 'spread': '5494', 'groupId': 'OG000'}, {'value': '8028', 'spread': '1963', 'groupId': 'OG001'}, {'value': '11229', 'spread': '2516', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '8614', 'spread': '8477', 'groupId': 'OG000'}, {'value': '6464', 'spread': '1377', 'groupId': 'OG001'}, {'value': '9776', 'spread': '2868', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category'}, {'type': 'SECONDARY', 'title': "AUClast for 5'DFUR", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '8855', 'spread': '1761', 'groupId': 'OG000'}, {'value': '5658', 'spread': '1237', 'groupId': 'OG001'}, {'value': '8951', 'spread': '2248', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '8500', 'spread': '9192', 'groupId': 'OG000'}, {'value': '4829', 'spread': '1015', 'groupId': 'OG001'}, {'value': '10017', 'spread': '3637', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category'}, {'type': 'SECONDARY', 'title': 'AUClast for 5-FU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '355', 'spread': '27', 'groupId': 'OG000'}, {'value': '291', 'spread': '95', 'groupId': 'OG001'}, {'value': '506', 'spread': '200', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1, Day 14', 'categories': [{'measurements': [{'value': '688', 'spread': '802', 'groupId': 'OG000'}, {'value': '350', 'spread': '129', 'groupId': 'OG001'}, {'value': '854', 'spread': '390', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2', 'description': 'Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '64.1'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '81.6'}, {'value': '46.7', 'groupId': 'OG002', 'lowerLimit': '21.3', 'upperLimit': '73.4'}, {'value': '43.5', 'groupId': 'OG003', 'lowerLimit': '23.2', 'upperLimit': '65.5'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '45.5', 'groupId': 'OG005', 'lowerLimit': '24.4', 'upperLimit': '67.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 21 of every even-numbered cycle up to 15 months', 'description': 'Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2', 'description': 'Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '14.1'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '10.9'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '28.1'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '12.8'}, {'value': '6.3', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '25.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Month 15', 'description': 'DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m\\^2, CAP 2000 mg/m\\^2 reporting group analyzed; all had stable disease during specified time frame'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2', 'description': 'Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.'}, {'id': 'OG001', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG002', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG003', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG004', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'OG005', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '9.3'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '8.0'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '13.9'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '9.4'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '2.3', 'upperLimit': '11.7'}, {'value': '5.5', 'groupId': 'OG005', 'lowerLimit': '4.7', 'upperLimit': '10.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Month 15', 'description': 'PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis subset of population of participants who had an event'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2', 'description': 'Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.'}, {'id': 'FG001', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'FG002', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'FG003', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'FG004', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'FG005', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'Participant refused treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2', 'description': 'Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.'}, {'id': 'BG001', 'title': 'SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'BG002', 'title': 'SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'BG003', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'BG004', 'title': 'SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'BG005', 'title': 'SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2', 'description': 'SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\\^2 oral tablets BID on Days 1-14 of each 21-day cycle.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '10.1', 'groupId': 'BG003'}, {'value': '63.3', 'spread': '11.6', 'groupId': 'BG004'}, {'value': '50.1', 'spread': '11.5', 'groupId': 'BG005'}, {'value': '52.4', 'spread': '10.9', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2007-11-06', 'resultsFirstSubmitDate': '2011-08-04', 'studyFirstSubmitQcDate': '2007-11-06', 'lastUpdatePostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-04', 'studyFirstPostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Baseline up to Day 21', 'description': 'Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having \\>3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery \\>14 days.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)'}, {'measure': 'Cmax of CAP', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': "Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': "Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': 'Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)'}, {'measure': 'Cmin of CAP', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': "Cmin of 5'DFCR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': "Cmin of 5'DFUR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': 'Cmin of 5-FU', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)'}, {'measure': 'Tmax for CAP', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': "Tmax for 5'DFCR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': "Tmax for 5'DFUR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': 'Tmax for 5-FU', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)'}, {'measure': 'Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 't1/2 for CAP', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': "t1/2 for 5'DFCR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': "t1/2 for 5'DFUR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 't1/2 for 5-FU', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)', 'timeFrame': 'Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)', 'description': 'Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.'}, {'measure': "Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}, {'measure': "Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU", 'timeFrame': 'Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)', 'description': 'AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': "AUClast for 5'DFCR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': "AUClast for 5'DFUR", 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'AUClast for 5-FU', 'timeFrame': 'Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Percentage of Participants With Objective Response', 'timeFrame': 'Baseline, Day 21 of every even-numbered cycle up to 15 months', 'description': 'Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline up to Month 15', 'description': 'DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline up to Month 15', 'description': 'PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24091982', 'type': 'DERIVED', 'citation': 'Lee KW, Park SR, Oh DY, Park YI, Khosravan R, Lin X, Lee SY, Roh EJ, Valota O, Lechuga MJ, Bang YJ. Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. Invest New Drugs. 2013 Dec;31(6):1547-58. doi: 10.1007/s10637-013-0032-y. Epub 2013 Oct 4.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181126&StudyName=Study%20Of%20Sunitinib%20%20In%20Combination%20With%20Cisplatin/Capecitabine%20Or%20Oxaliplatin/Capecitabine%20In%20Patients%20With%20Advanced%20Gastric%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of stomach cancer\n* advanced stomach cancer of stage IV\n* adequate blood chemistry, blood counts and kidney function\n* willing to participate to study requirements and sign an informed consent document\n\nExclusion Criteria:\n\n* prior chemotherapy for the stomach cancer in its advanced stage\n* excessive toxicities related to prior therapies\n* pregnant or breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT00555620', 'briefTitle': 'Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'A6181126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: capecitabine', 'Drug: oxaliplatin', 'Drug: sunitinib malate']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: capecitabine', 'Drug: cisplatin', 'Drug: sunitinib malate']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'description': 'Capecitabine is given orally at 1000mg/m\\^2 twice a day for 14 days followed by 7 days of drug free period.', 'armGroupLabels': ['A']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin is given 110mg/m\\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.', 'armGroupLabels': ['A']}, {'name': 'sunitinib malate', 'type': 'DRUG', 'otherNames': ['Sutent'], 'description': 'sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.', 'armGroupLabels': ['A']}, {'name': 'capecitabine', 'type': 'DRUG', 'description': 'Capecitabine is given orally at 1000mg/m\\^2 twice a day for 14 days followed by 7 days of drug free period.', 'armGroupLabels': ['B']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': 'Cisplatin is given 80mg/m\\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.', 'armGroupLabels': ['B']}, {'name': 'sunitinib malate', 'type': 'DRUG', 'description': 'sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}