Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT00460603
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2007-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077784', 'term': 'Axitinib'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Time to Treatment Failure (TTF) was included as a secondary endpoint of the study after change in analysis plan.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1)', 'description': "Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 2)', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 3)', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 6)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 7)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 8)', 'description': "Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 9)', 'description': "Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'seriousNumAffected': 8}, {'id': 'EG009', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'seriousNumAffected': 15}, {'id': 'EG010', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 43, 'otherNumAffected': 42, 'seriousNumAtRisk': 43, 'seriousNumAffected': 17}, {'id': 'EG011', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.", 'otherNumAtRisk': 41, 'otherNumAffected': 39, 'seriousNumAtRisk': 41, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anaemia megaloblastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypercoagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Microcytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 15}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 21}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 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0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Objective Response: Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '44.6'}, {'value': '48.8', 'groupId': 'OG001', 'lowerLimit': '33.3', 'upperLimit': '64.5'}, {'value': '39.0', 'groupId': 'OG002', 'lowerLimit': '24.2', 'upperLimit': '55.5'}]}]}], 'analyses': [{'pValue': '0.9726', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.585', 'ciLowerLimit': '0.332', 'ciUpperLimit': '1.031', 'groupDescription': 'One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus \\[vs.\\] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8391', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.735', 'ciLowerLimit': '0.399', 'ciUpperLimit': '1.352', 'groupDescription': 'One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8192', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.797', 'ciLowerLimit': '0.489', 'ciUpperLimit': '1.299', 'groupDescription': 'One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as \\>=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study \\>=4 weeks after initial documentation of response.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 8', 'categories': [{'measurements': [{'value': '119.02', 'groupId': 'OG000', 'lowerLimit': '56.17', 'upperLimit': '252.21'}, {'value': '106.76', 'groupId': 'OG001', 'lowerLimit': '27.27', 'upperLimit': '417.89'}, {'value': '97.05', 'groupId': 'OG002', 'lowerLimit': '49.01', 'upperLimit': '192.16'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '95.70', 'groupId': 'OG000', 'lowerLimit': '45.16', 'upperLimit': '202.80'}, {'value': '143.68', 'groupId': 'OG001', 'lowerLimit': '36.70', 'upperLimit': '562.43'}, {'value': '117.47', 'groupId': 'OG002', 'lowerLimit': '59.32', 'upperLimit': '232.60'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.', 'unitOfMeasure': 'nanogram hour per milliliter (ng*hr/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 8', 'categories': [{'measurements': [{'value': '190.51', 'groupId': 'OG000', 'lowerLimit': '77.99', 'upperLimit': '465.35'}, {'value': '113.20', 'groupId': 'OG001', 'lowerLimit': '8.89', 'upperLimit': '1442.19'}, {'value': '205.41', 'groupId': 'OG002', 'lowerLimit': '53.61', 'upperLimit': '787.01'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '224.46', 'groupId': 'OG000', 'lowerLimit': '91.89', 'upperLimit': '548.29'}, {'value': '168.07', 'groupId': 'OG001', 'lowerLimit': '13.19', 'upperLimit': '2141.15'}, {'value': '178.46', 'groupId': 'OG002', 'lowerLimit': '46.58', 'upperLimit': '683.73'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞\\] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 8', 'categories': [{'measurements': [{'value': '35.57', 'groupId': 'OG000', 'lowerLimit': '18.37', 'upperLimit': '68.89'}, {'value': '27.14', 'groupId': 'OG001', 'lowerLimit': '7.40', 'upperLimit': '99.49'}, {'value': '24.23', 'groupId': 'OG002', 'lowerLimit': '14.32', 'upperLimit': '40.98'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '27.51', 'groupId': 'OG000', 'lowerLimit': '14.20', 'upperLimit': '53.28'}, {'value': '42.48', 'groupId': 'OG001', 'lowerLimit': '11.59', 'upperLimit': '155.73'}, {'value': '32.62', 'groupId': 'OG002', 'lowerLimit': '19.29', 'upperLimit': '55.18'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) For Axitinib: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 8', 'categories': [{'measurements': [{'value': '30.01', 'groupId': 'OG000', 'lowerLimit': '15.05', 'upperLimit': '59.82'}, {'value': '47.10', 'groupId': 'OG001', 'lowerLimit': '3.72', 'upperLimit': '596.29'}, {'value': '28.49', 'groupId': 'OG002', 'lowerLimit': '9.32', 'upperLimit': '87.03'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '30.08', 'groupId': 'OG000', 'lowerLimit': '15.09', 'upperLimit': '59.96'}, {'value': '33.33', 'groupId': 'OG001', 'lowerLimit': '2.63', 'upperLimit': '421.92'}, {'value': '28.90', 'groupId': 'OG002', 'lowerLimit': '9.46', 'upperLimit': '88.31'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'Liter per hour (L/hr)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 8', 'categories': [{'measurements': [{'value': '3.26', 'spread': '3.943', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.702', 'groupId': 'OG001'}, {'value': '3.47', 'spread': '2.820', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '6.12', 'spread': '7.450', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '0.889', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '0.456', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '4814.87', 'groupId': 'OG000', 'lowerLimit': '4079.46', 'upperLimit': '5682.84'}, {'value': '4308.71', 'groupId': 'OG001', 'lowerLimit': '2822.77', 'upperLimit': '6576.87'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '5231.71', 'groupId': 'OG000', 'lowerLimit': '4432.64', 'upperLimit': '6174.83'}, {'value': '5303.66', 'groupId': 'OG001', 'lowerLimit': '3474.59', 'upperLimit': '8095.57'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '5955.70', 'groupId': 'OG000', 'lowerLimit': '4615.41', 'upperLimit': '7685.21'}, {'value': '5137.31', 'groupId': 'OG001', 'lowerLimit': '3296.14', 'upperLimit': '8006.93'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '6744.06', 'groupId': 'OG000', 'lowerLimit': '5226.35', 'upperLimit': '8702.50'}, {'value': '6430.67', 'groupId': 'OG001', 'lowerLimit': '4125.97', 'upperLimit': '10022.74'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '278.81', 'groupId': 'OG000', 'lowerLimit': '201.38', 'upperLimit': '386.03'}, {'value': '265.05', 'groupId': 'OG001', 'lowerLimit': '67.62', 'upperLimit': '1038.93'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '318.99', 'groupId': 'OG000', 'lowerLimit': '230.40', 'upperLimit': '441.66'}, {'value': '374.03', 'groupId': 'OG001', 'lowerLimit': '95.42', 'upperLimit': '1466.10'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) For Oxaliplatin: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '27.51', 'groupId': 'OG000', 'lowerLimit': '21.56', 'upperLimit': '35.11'}, {'value': '30.74', 'groupId': 'OG001', 'lowerLimit': '18.48', 'upperLimit': '51.13'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '24.29', 'groupId': 'OG000', 'lowerLimit': '19.04', 'upperLimit': '31.00'}, {'value': '24.56', 'groupId': 'OG001', 'lowerLimit': '14.76', 'upperLimit': '40.85'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'L/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '20.63', 'spread': '6.513', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '3.004', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '23.30', 'spread': '14.975', 'groupId': 'OG000'}, {'value': '19.86', 'spread': '4.110', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '39212.03', 'groupId': 'OG000', 'lowerLimit': '22388.50', 'upperLimit': '68677.39'}, {'value': '40955.29', 'groupId': 'OG001', 'lowerLimit': '23831.07', 'upperLimit': '70384.39'}, {'value': '52164.28', 'groupId': 'OG002', 'lowerLimit': '4725.16', 'upperLimit': '575877.57'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '45087.71', 'groupId': 'OG000', 'lowerLimit': '25743.27', 'upperLimit': '78968.27'}, {'value': '36533.84', 'groupId': 'OG001', 'lowerLimit': '21258.32', 'upperLimit': '62785.83'}, {'value': '95123.13', 'groupId': 'OG002', 'lowerLimit': '8616.47', 'upperLimit': '1050129.94'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '36314.14', 'groupId': 'OG000', 'lowerLimit': '19623.50', 'upperLimit': '67200.90'}, {'value': '41460.50', 'groupId': 'OG001', 'lowerLimit': '23968.34', 'upperLimit': '71718.51'}, {'value': '52430.15', 'groupId': 'OG002', 'lowerLimit': '4751.38', 'upperLimit': '578551.86'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '38983.80', 'groupId': 'OG000', 'lowerLimit': '21066.13', 'upperLimit': '72141.23'}, {'value': '36776.79', 'groupId': 'OG001', 'lowerLimit': '21260.68', 'upperLimit': '63616.60'}, {'value': '96632.41', 'groupId': 'OG002', 'lowerLimit': '8757.13', 'upperLimit': '1066311.16'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '16160.85', 'groupId': 'OG000', 'lowerLimit': '6975.82', 'upperLimit': '37439.78'}, {'value': '34436.94', 'groupId': 'OG001', 'lowerLimit': '22763.46', 'upperLimit': '52096.78'}, {'value': '19622.74', 'groupId': 'OG002', 'lowerLimit': '2754.12', 'upperLimit': '139809.41'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '16249.77', 'groupId': 'OG000', 'lowerLimit': '7014.20', 'upperLimit': '37645.79'}, {'value': '39730.46', 'groupId': 'OG001', 'lowerLimit': '26262.58', 'upperLimit': '60104.90'}, {'value': '34180.87', 'groupId': 'OG002', 'lowerLimit': '4797.41', 'upperLimit': '243534.09'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) For 5-Fluorouracil: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '147.43', 'groupId': 'OG000', 'lowerLimit': '77.38', 'upperLimit': '280.93'}, {'value': '128.28', 'groupId': 'OG001', 'lowerLimit': '73.44', 'upperLimit': '224.05'}, {'value': '99.36', 'groupId': 'OG002', 'lowerLimit': '10.18', 'upperLimit': '969.40'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '137.34', 'groupId': 'OG000', 'lowerLimit': '72.08', 'upperLimit': '261.70'}, {'value': '144.62', 'groupId': 'OG001', 'lowerLimit': '82.80', 'upperLimit': '252.59'}, {'value': '53.92', 'groupId': 'OG002', 'lowerLimit': '5.53', 'upperLimit': '526.06'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'L/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.218', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.069', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.291', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.131', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '12081.58', 'groupId': 'OG000', 'lowerLimit': '8805.17', 'upperLimit': '16577.15'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '11496.32', 'groupId': 'OG000', 'lowerLimit': '8378.62', 'upperLimit': '15774.11'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '13055.88', 'groupId': 'OG000', 'lowerLimit': '9371.39', 'upperLimit': '18188.96'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '12459.89', 'groupId': 'OG000', 'lowerLimit': '8943.60', 'upperLimit': '17358.66'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '1910.25', 'groupId': 'OG000', 'lowerLimit': '1561.45', 'upperLimit': '2336.97'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '1788.69', 'groupId': 'OG000', 'lowerLimit': '1462.08', 'upperLimit': '2188.26'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) For Irinotecan: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 8', 'categories': [{'measurements': [{'value': '26.09', 'groupId': 'OG000', 'lowerLimit': '18.10', 'upperLimit': '37.61'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '27.34', 'groupId': 'OG000', 'lowerLimit': '18.97', 'upperLimit': '39.40'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'L/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '6.45', 'spread': '1.406', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '6.75', 'spread': '0.886', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '3394758.83', 'groupId': 'OG000', 'lowerLimit': '2453600.72', 'upperLimit': '4696928.65'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '3554899.52', 'groupId': 'OG000', 'lowerLimit': '2569344.23', 'upperLimit': '4918496.49'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '4987528.96', 'groupId': 'OG000', 'lowerLimit': '3395240.62', 'upperLimit': '7326563.24'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '5114888.84', 'groupId': 'OG000', 'lowerLimit': '3481940.36', 'upperLimit': '7513651.92'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '26460.05', 'groupId': 'OG000', 'lowerLimit': '19574.60', 'upperLimit': '35767.50'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '26850.12', 'groupId': 'OG000', 'lowerLimit': '19863.16', 'upperLimit': '36294.76'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) For Bevacizumab: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.02'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.02'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'L/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)', 'description': "Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': '205.97', 'spread': '46.454', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1', 'categories': [{'measurements': [{'value': '210.22', 'spread': '55.317', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR): Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '434.0', 'groupId': 'OG000', 'lowerLimit': '246.0', 'upperLimit': '666.0'}, {'value': 'NA', 'comment': 'Data was not estimable since high number of participants was censored for this measure.', 'groupId': 'OG001', 'lowerLimit': '232.0', 'upperLimit': 'NA'}, {'value': '343.0', 'groupId': 'OG002', 'lowerLimit': '168.0', 'upperLimit': '490.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: \\>=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: \\>=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. 'N' (Number of participants analyzed)= those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS): Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000', 'lowerLimit': '225.0', 'upperLimit': '749.0'}, {'value': '485', 'comment': 'Data was not estimable since high number of participants was censored for this measure.', 'groupId': 'OG001', 'lowerLimit': '276.0', 'upperLimit': 'NA'}, {'value': '381', 'groupId': 'OG002', 'lowerLimit': '238.0', 'upperLimit': '425.0'}]}]}], 'analyses': [{'pValue': '0.5699', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.47', 'ciUpperLimit': '2.45', 'groupDescription': 'Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2167', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.61', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8746', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.98', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was "Death"). Progression: \\>=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF): Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '187.0', 'groupId': 'OG000', 'lowerLimit': '162.0', 'upperLimit': '315.0'}, {'value': '241.0', 'groupId': 'OG001', 'lowerLimit': '205.0', 'upperLimit': '344.0'}, {'value': '238.0', 'groupId': 'OG002', 'lowerLimit': '155.0', 'upperLimit': '333.0'}]}]}], 'analyses': [{'pValue': '0.8884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '0.81', 'ciUpperLimit': '2.41', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6648', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.89', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8065', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.07', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: \\>=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS): Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '552.0', 'groupId': 'OG000', 'lowerLimit': '443.0', 'upperLimit': '911.0'}, {'value': '659.0', 'groupId': 'OG001', 'lowerLimit': '493.0', 'upperLimit': '899.0'}, {'value': '601.0', 'groupId': 'OG002', 'lowerLimit': '533.0', 'upperLimit': '882.0'}]}]}], 'analyses': [{'pValue': '0.6904', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.155', 'ciLowerLimit': '0.656', 'ciUpperLimit': '2.033', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7364', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.203', 'ciLowerLimit': '0.676', 'ciUpperLimit': '2.141', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4140', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.941', 'ciLowerLimit': '0.535', 'ciUpperLimit': '1.653', 'groupDescription': 'Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant', 'description': 'Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants , with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'OG002', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'classes': [{'title': 'Severity Scale: Baseline (n=41,43,40)', 'categories': [{'measurements': [{'value': '1.62', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '1.93', 'groupId': 'OG001'}, {'value': '2.18', 'spread': '2.06', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C2D1 (n=37,37,37)', 'categories': [{'measurements': [{'value': '0.63', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C3D1 (n=32,38,32)', 'categories': [{'measurements': [{'value': '0.68', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '1.61', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C4D1 (n=23,37,30)', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '1.68', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C5D1 (n=23,34,29)', 'categories': [{'measurements': [{'value': '0.72', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '0.60', 'spread': '2.13', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C6D1 (n=15,38,26)', 'categories': [{'measurements': [{'value': '0.70', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '1.60', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C7D1 (n=12,30,22)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '1.22', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C8D1 (n=17,29,22)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '1.74', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C9D1 (n=11,24,21)', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.67', 'groupId': 'OG001'}, {'value': '0.76', 'spread': '1.50', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C10D1 (n=14,27,21)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '1.52', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C11D1 (n=10,20,19)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C12D1 (n=11,23,16)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '1.14', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C13D1 (n=8,13,12)', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C14D1 (n=8,17,14)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C15D1 (n=7,11,9)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C16D1 (n=7,17,14)', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '2.08', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C17D1 (n=5,11,6)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '1.07', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C18D1 (n=6,14,9)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '1.55', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C19D1 (n=4,8,16)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '0.81', 'spread': '2.32', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C20D1 (n=5,14,8)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '1.67', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C21D1 (n=4,5,5)', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '1.35', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C22D1 (n=3,11,8)', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '1.37', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C23D1 (n=4,5,3)', 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C24D1 (n=5,11,7)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '1.62', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C25D1 (n=4,5,5)', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '1.63', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C26D1 (n=4,6,7)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '1.79', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C27D1 (n=4,3,4)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '2.70', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C28D1 (n=4,5,7)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C29D1 (n=2,3,4)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '2.51', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C30D1 (n=3,6,3)', 'categories': [{'measurements': [{'value': '1.05', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.68', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C31D1 (n=1,1,3)', 'categories': [{'measurements': [{'value': '-0.50', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': '1.55', 'spread': '1.69', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C32D1 (n=2,4,4)', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '1.03', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C33D1 (n=0,0,2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '1.26', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C34D1 (n=2,4,3)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.74', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C35D1 (n=0,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG001'}, {'value': '0.79', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C36D1 (n=2,3,2)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.25', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C37D1 (n=0,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': '0.86', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C38D1 (n=2,2,1)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '0.86', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C39D1 (n=0,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': '0.86', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C40D1 (n=2,2,2)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: C42D1 (n=2,2,1)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Severity Scale: Follow_Up (n=4,15,14)', 'categories': [{'measurements': [{'value': '1.29', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '1.66', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '1.72', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: Baseline (n=41,43,40)', 'categories': [{'measurements': [{'value': '2.50', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '2.47', 'spread': '2.66', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C2D1 (n=37,37,36)', 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '1.74', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '2.55', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C3D1 (n=31,38,30)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '1.88', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '2.37', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C4D1 (n=23,36,30)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '2.37', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C5D1 (n=23,34,29)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '2.90', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C6D1 (n=15,38,26)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '2.33', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '2.54', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C7D1 (n=12,30,22)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '2.05', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C8D1 (n=17,29,22)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '1.87', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C9D1 (n=11,24,21)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '1.76', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C10D1 (n=14,27,21)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C11D1 (n=10,20,19)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '2.50', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C12D1 (n=10,23,16)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '1.51', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C13D1 (n=8,13,12)', 'categories': [{'measurements': [{'value': '-0.50', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '1.70', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C14D1 (n=8,17,14)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C15D1 (n=7,11,9)', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '0.70', 'spread': '2.36', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C16D1 (n=7,17,14)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '2.38', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C17D1 (n=5,11,6)', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C18D1 (n=6,14,9)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '2.26', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C19D1 (n=4,8,6)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '1.84', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C20D1 (n=5,14,8)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '2.07', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C21D1 (n=4,5,5)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '3.50', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C22D1 (n=3,11,8)', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '2.05', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C23D1 (n=4,5,3)', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '1.28', 'spread': '1.80', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C24D1 (n=5,11,7)', 'categories': [{'measurements': [{'value': '2.00', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '2.33', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C25D1 (n=4,5,5)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C26D1 (n=4,6,7)', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.80', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '2.11', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C27D1 (n=4,3,4)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.63', 'spread': '2.44', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C28D1 (n=4,5,7)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '2.40', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C29D1 (n=2,3,4)', 'categories': [{'measurements': [{'value': '3.25', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '1.33', 'spread': '2.97', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C30D1 (n=3,6,3)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '1.06', 'spread': '1.83', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C31D1 (n=1,1,3)', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '2.08', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C32D1 (n=2,4,4)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '1.81', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C33D1 (n=0,0,2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG001'}, {'value': '1.92', 'spread': '2.71', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C34D1 (n=2,4,3)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '1.11', 'spread': '1.51', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C35D1 (n=0,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG001'}, {'value': '1.67', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C36D1 (n=2,3,2)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '1.33', 'spread': '1.89', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C37D1 (n=0,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': '0.83', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C38D1 (n=2,2,1)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C39D1 (n=0,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG000'}, {'value': '0.50', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C40D1 (n=2,2,2)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: C42D1 (n=2,2,1)', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Interference Scale: Follow Up (n=4,15,14)', 'categories': [{'measurements': [{'value': '1.33', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '2.44', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '1.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose', 'description': 'PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was "at its worst". Each item is scored from 0 to 10, with \'0\' indicating that the symptom was either not present or did not interfere with their activities, and \'10\' indicating that the symptom was "as bad as you can imagine" or "interfered completely" with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)', 'description': "Bevacizumab 1 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 milligram per square meter (mg/m\\^2) intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-fluorouracil (5-FU) 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG001', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG002', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG003', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG004', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG005', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 6)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG006', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 7)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG007', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 8)', 'description': "Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG008', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 9)', 'description': "Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG009', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG010', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'FG011', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '18'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '18'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '42'}, {'groupId': 'FG010', 'numSubjects': '43'}, {'groupId': 'FG011', 'numSubjects': '41'}]}, {'type': 'Treated', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '39'}, {'groupId': 'FG010', 'numSubjects': '43'}, {'groupId': 'FG011', 'numSubjects': '41'}]}, {'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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT 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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '42'}, {'groupId': 'FG010', 'numSubjects': '43'}, {'groupId': 'FG011', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Ongoing in study A4061008 (NCT00828919)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '12'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 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'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '16'}, {'groupId': 'FG011', 'numSubjects': '7'}]}, {'type': 'Objective Progression or Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '17'}]}, {'type': 'Global Deterioration of Health Status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '5'}]}, {'type': 'Randomized, but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '42', 'groupId': 'BG009'}, {'value': '43', 'groupId': 'BG010'}, {'value': '41', 'groupId': 'BG011'}, {'value': '187', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)', 'description': "Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG001', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG002', 'title': 'Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG003', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 4)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG004', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 5)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG005', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 6)', 'description': "FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG006', 'title': 'Phase 1: Axitinib + FOLFOX (Cohort 7)', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG007', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 8)', 'description': "Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG008', 'title': 'Phase 1: Axitinib + FOLFIRI (Cohort 9)', 'description': "Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m\\^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG009', 'title': 'Phase 2: Axitinib + FOLFOX', 'description': "FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG010', 'title': 'Phase 2: Bevacizumab + FOLFOX', 'description': "Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG011', 'title': 'Phase 2: Axitinib + Bevacizumab + FOLFOX', 'description': "Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m\\^2 intravenous infusion over 2 hours, leucovorin 400 mg/m\\^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m\\^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m\\^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion."}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}, {'title': '18 to 44 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '21', 'groupId': 'BG012'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '22', 'groupId': 'BG009'}, {'value': '18', 'groupId': 'BG010'}, {'value': '23', 'groupId': 'BG011'}, {'value': '96', 'groupId': 'BG012'}]}]}, {'title': 'Greater than or equal to (>=) 65 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '18', 'groupId': 'BG009'}, {'value': '21', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '70', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '17', 'groupId': 'BG009'}, {'value': '15', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}, {'value': '67', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '25', 'groupId': 'BG009'}, {'value': '28', 'groupId': 'BG010'}, {'value': '26', 'groupId': 'BG011'}, {'value': '120', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2007-04-13', 'resultsFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2007-04-13', 'lastUpdatePostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-03', 'studyFirstPostDateStruct': {'date': '2007-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Objective Response: Phase 2', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as \\>=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study \\>=4 weeks after initial documentation of response.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞\\] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1'}, {'measure': 'Apparent Oral Clearance (CL/F) For Axitinib: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1'}, {'measure': 'Clearance (CL) For Oxaliplatin: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1'}, {'measure': 'Clearance (CL) For 5-Fluorouracil: Phase 1', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1', 'timeFrame': 'Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1'}, {'measure': 'Clearance (CL) For Irinotecan: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1'}, {'measure': 'Clearance (CL) For Bevacizumab: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1', 'timeFrame': 'Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1', 'description': 'Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.'}, {'measure': 'Duration of Response (DR): Phase 2', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: \\>=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: \\>=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.'}, {'measure': 'Progression-Free Survival (PFS): Phase 2', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was "Death"). Progression: \\>=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.'}, {'measure': 'Time to Treatment Failure (TTF): Phase 2', 'timeFrame': 'Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)', 'description': 'TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: \\>=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.'}, {'measure': 'Overall Survival (OS): Phase 2', 'timeFrame': 'Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant', 'description': 'Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).'}, {'measure': 'Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2', 'timeFrame': 'Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose', 'description': 'PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was "at its worst". Each item is scored from 0 to 10, with \'0\' indicating that the symptom was either not present or did not interfere with their activities, and \'10\' indicating that the symptom was "as bad as you can imagine" or "interfered completely" with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GI neoplasms (phase 1)'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24423921', 'type': 'DERIVED', 'citation': 'Hoh CK, Burris HA 3rd, Bendell JC, Tarazi J, Rosbrook B, Kim S, Infante JR, Reid TR. Intermittent dosing of axitinib combined with chemotherapy is supported by (18)FLT-PET in gastrointestinal tumours. Br J Cancer. 2014 Feb 18;110(4):875-81. doi: 10.1038/bjc.2013.806. Epub 2014 Jan 14.'}, {'pmid': '23605883', 'type': 'DERIVED', 'citation': 'Infante JR, Reid TR, Cohn AL, Edenfield WJ, Cescon TP, Hamm JT, Malik IA, Rado TA, McGee PJ, Richards DA, Tarazi J, Rosbrook B, Kim S, Cartwright TH. Axitinib and/or bevacizumab with modified FOLFOX-6 as first-line therapy for metastatic colorectal cancer: a randomized phase 2 study. Cancer. 2013 Jul 15;119(14):2555-63. doi: 10.1002/cncr.28112. Epub 2013 Apr 19.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061020&StudyName=Study%20With%20AG-013736%20Combined%20With%20Chemotherapy%20And%20Bevacizumab%20In%20Patients%20With%20Metastatic%20Colorectal%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment\n* (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.\n* Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was \\> 12 months prior to enrollment,\n* Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.\n\nExclusion Criteria:\n\n* Prior system therapy for advanced CRC (Ph 2 portion only)\n* Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.\n* Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)\n* Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed \\> 2 weeks of enrollment and be fully recovered from any procedure.'}, 'identificationModule': {'nctId': 'NCT00460603', 'briefTitle': 'Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion', 'orgStudyIdInfo': {'id': 'A4061020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'bevacizumab 5 mg/kg every 2 weeks + FOLFOX', 'interventionNames': ['Drug: bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX', 'interventionNames': ['Drug: AG-013726']}, {'type': 'EXPERIMENTAL', 'label': 'A', 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