Viewing Study NCT00615056

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Ignite Creation Date: 2025-12-24 @ 11:35 PM
Ignite Modification Date: 2026-04-02 @ 3:03 PM
Study NCT ID: NCT00615056
Status: COMPLETED
Last Update Posted: 2013-04-19
First Post: 2008-02-01
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Czechia']}, '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': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077784', 'term': 'Axitinib'}, {'id': 'C410216', 'term': 'Folfox protocol'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], '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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as 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': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.', 'otherNumAtRisk': 46, 'otherNumAffected': 45, 'seriousNumAtRisk': 46, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.', 'otherNumAtRisk': 51, 'otherNumAffected': 51, 'seriousNumAtRisk': 51, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.', 'otherNumAtRisk': 36, 'otherNumAffected': 35, 'seriousNumAtRisk': 36, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.', 'otherNumAtRisk': 35, 'otherNumAffected': 33, 'seriousNumAtRisk': 35, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'External ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otosalpingitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal inflammation', 'stats': 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{'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Performance status decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis pharyngeal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.72', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '7.42'}, {'value': '6.87', 'groupId': 'OG001', 'lowerLimit': '4.96', 'upperLimit': '9.13'}, {'value': '7.59', 'groupId': 'OG002', 'lowerLimit': '5.62', 'upperLimit': '11.07'}, {'value': '6.44', 'groupId': 'OG003', 'lowerLimit': '5.52', 'upperLimit': '13.11'}]}]}], 'analyses': [{'pValue': '0.8268', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.273', 'ciLowerLimit': '0.769', 'ciUpperLimit': '2.108', 'pValueComment': 'One-sided log-rank test at alpha = 0.15 significance level was used.', 'groupDescription': 'Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5498', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.041', 'ciLowerLimit': '0.553', 'ciUpperLimit': '1.041', 'pValueComment': 'One-sided log-rank test at alpha = 0.15 significance level was used.', 'groupDescription': 'Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks', 'description': 'Time in months from start of study treatment 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) divided by 30.4. 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").', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '16.6'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '23.0'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '10.1', 'upperLimit': '23.0'}, {'value': '14.1', 'groupId': 'OG003', 'lowerLimit': '9.0', 'upperLimit': '16.4'}]}]}], 'analyses': [{'pValue': '0.8828', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.355', 'ciLowerLimit': '0.820', 'ciUpperLimit': '2.238', 'pValueComment': 'One-sided log-rank test at alpha = 0.15 significance level was used.', 'groupDescription': 'Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1159', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.689', 'ciLowerLimit': '0.373', 'ciUpperLimit': '1.273', 'pValueComment': 'One-sided log-rank test at alpha = 0.15 significance level was used.', 'groupDescription': 'Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until death or up to 1 year after the randomization of last participant', 'description': 'Time in months from the start of study treatment 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) divided by 30.4. 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': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '38.9'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '37.5'}, {'value': '19.4', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '36.0'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '8.4', 'upperLimit': '36.9'}]}]}], 'analyses': [{'pValue': '0.4552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '17.7', 'groupDescription': 'One-sided Pearson chi square test at alpha = 0.15 significance level was used.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5235', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-19.1', 'ciUpperLimit': '18.0', 'groupDescription': 'One-sided Pearson chi square test at alpha = 0.15 significance level was used.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.52', 'comment': 'Upper limit of confidence interval was not estimable due to the large number of participants censored.', 'groupId': 'OG000', 'lowerLimit': '5.22', 'upperLimit': 'NA'}, {'value': '12.29', 'groupId': 'OG001', 'lowerLimit': '7.39', 'upperLimit': '12.84'}, {'value': '10.15', 'groupId': 'OG002', 'lowerLimit': '4.17', 'upperLimit': '12.91'}, {'value': '10.94', 'groupId': 'OG003', 'lowerLimit': '4.53', 'upperLimit': '12.68'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks', 'description': 'Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. 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) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}], 'classes': [{'title': 'Baseline (n=39,46,35,33)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.6'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.2'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '2.5'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '2.7'}]}]}, {'title': 'Change at Cycle 2/Day 1 (n=35, 39, 34,28)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.0'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-0.4', 'upperLimit': '0.5'}]}]}, {'title': 'Change at Cycle 3/Day 1 (n=36,36,33,26)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.6'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '-0.4', 'upperLimit': '1.0'}, {'value': '0.2', 'groupId': 'OG003', 'lowerLimit': '-0.3', 'upperLimit': '0.7'}]}]}, {'title': 'Change at Cycle 4/Day 1 (n=29,37,32,25)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.5'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '1.1'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '-0.1', 'upperLimit': '1.1'}]}]}, {'title': 'Change at Cycle 5/Day 1 (n=28,29,24,24)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.7'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '1.7'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '-0.2', 'upperLimit': '0.9'}]}]}, {'title': 'Change at Cycle 7/Day 1 (n=26,31,22,20)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.5'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '1.1'}, {'value': '0.2', 'groupId': 'OG003', 'lowerLimit': '-0.5', 'upperLimit': '0.9'}]}]}, {'title': 'Change at Cycle 9/Day 1 (n=19,26,19,17)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.9'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.2'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '1.3'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '1.3'}]}]}, {'title': 'Change at Cycle 11/Day 1 (n=15,24,16,15)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.9'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.7'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '1.8'}, {'value': '0.1', 'groupId': 'OG003', 'lowerLimit': '-0.8', 'upperLimit': '1.1'}]}]}, {'title': 'Change at Cycle 13/Day 1 (n=13,19,15,10)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '2.6'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.7'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '1.6'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '1.4'}]}]}, {'title': 'Change at Cycle 15/Day 1 (n=7,17,12,8)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '3.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.7'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-0.4', 'upperLimit': '1.3'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '1.6'}]}]}, {'title': 'Change at Cycle 17/Day 1 (n=6,11,11,7)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '5.0'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '1.0'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '1.8'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '2.7'}]}]}, {'title': 'Change at Cycle 19/Day 1 (n=6,10,9,5)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '4.1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '1.7'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '1.8'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '2.2'}]}]}, {'title': 'Change at Cycle 21/Day 1 (n=6,9,7,4)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '4.4'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '1.5'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '2.7'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '2.8'}]}]}, {'title': 'Change at Cycle 23/Day 1 (n=5,7,6,4)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.8'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '0.3'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '2.3'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '1.2'}]}]}, {'title': 'Change at Cycle 25/Day 1 (n=5,7,6,3)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '5.6'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '1.4'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '-2.0', 'upperLimit': '2.3'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '1.4'}]}]}, {'title': 'Change at Cycle 27/Day 1 (n=2,7,3,3)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '-20.8', 'upperLimit': '25.5'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '2.3'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '-5.4', 'upperLimit': '5.9'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '1.5'}]}]}, {'title': 'Change at Cycle 29/Day 1 (n=2,5,2,3)', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '-25.8', 'upperLimit': '31.4'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '0.9'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '0.1'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '-0.3', 'upperLimit': '2.1'}]}]}, {'title': 'Change at Cycle 31/Day 1 (n=1,5,2,2)', 'categories': [{'measurements': [{'value': '4.9', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '0.3'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-5.7', 'upperLimit': '5.2'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '-1.4', 'upperLimit': '3.2'}]}]}, {'title': 'Change at Cycle 33/Day 1 (n=1,3,2,1)', 'categories': [{'measurements': [{'value': '5.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '2.0'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-7.6', 'upperLimit': '6.1'}, {'value': '0.5', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 35/Day 1 (n=0,4,1,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '0.7'}, {'value': '0.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 37/Day 1 (n=0,4,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '0.4'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 39/Day 1 (n=0,2,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.1'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 41/Day 1 (n=0,2,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.1'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 43/Day 1 (n=0,1,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 45/Day 1 (n=0,0,0,1 )', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.2', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 47/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 49/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.5', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 51/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 53/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 55/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 57/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 59/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 61/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.2', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 63/Day 1 (n=0,0,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 65/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at end of treatment (n=21,29,27,22)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '1.6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.0'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '2.1'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal', 'description': 'Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' is number of participants analyzed at specific time point for each treatment arm respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'OG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}], 'classes': [{'title': 'Baseline (n=39,46,35,33)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.8'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '2.3'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '3.2'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '3.9'}]}]}, {'title': 'Change at Cycle 2/Day 1 (n=35, 39, 34, 28)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.6'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '0.7'}, {'value': '-0.5', 'groupId': 'OG003', 'lowerLimit': '-1.2', 'upperLimit': '0.1'}]}]}, {'title': 'Change at Cycle 3/Day 1 (n=36,36,33,26)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.2'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.8'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '1.2'}, {'value': '-0.2', 'groupId': 'OG003', 'lowerLimit': '-1.0', 'upperLimit': '0.6'}]}]}, {'title': 'Change at Cycle 4/Day 1 (n=29,37,32,25)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '1.7'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '0.4'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '1.1'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '-0.2', 'upperLimit': '1.3'}]}]}, {'title': 'Change at Cycle 5/Day 1 (n=28,29,24,24)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.6'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '1.4'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '-0.4', 'upperLimit': '2.0'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '-0.6', 'upperLimit': '1.2'}]}]}, {'title': 'Change at Cycle 7/Day 1 (n=26,30,22,20)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '1.5'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '1.2'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '1.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-0.8', 'upperLimit': '0.7'}]}]}, {'title': 'Change at Cycle 9/Day 1 (n=18,25,19,17)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.9'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '1.1'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '1.6'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '-0.8', 'upperLimit': '1.4'}]}]}, {'title': 'Change at Cycle 11/Day 1 (n=15,24,16,15)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '1.3'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '-0.2', 'groupId': 'OG003', 'lowerLimit': '-1.6', 'upperLimit': '1.2'}]}]}, {'title': 'Change at Cycle 13/Day 1 (n=13,19,15,10)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '2.7'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '1.5'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '2.2'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '-0.7', 'upperLimit': '2.1'}]}]}, {'title': 'Change at Cycle 15/Day 1 (n=7,17,12,8)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '2.0'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '1.3'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Change at Cycle 17/Day 1 (n=6,11,11,7)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.8'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '2.1'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '-1.3', 'upperLimit': '2.6'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '-0.1', 'upperLimit': '4.3'}]}]}, {'title': 'Change at Cycle 19/Day 1 (n=6,10,9,5)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.6'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '2.3'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '-1.6', 'upperLimit': '2.2'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '3.7'}]}]}, {'title': 'Change at Cycle 21/Day 1 (n=6,9,7,4)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '3.7'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '3.2'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '1.8'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '3.4'}]}]}, {'title': 'Change at Cycle 23/Day 1 (n=5,7,6,4)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.4'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '0.8'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '3.4'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '2.0'}]}]}, {'title': 'Change at Cycle 25/Day 1 (n=5,7,6,3)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '4.1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '3.0'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-2.7', 'upperLimit': '1.5'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '2.3'}]}]}, {'title': 'Change at Cycle 27/Day 1 (n=2,7,3,3)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-16.4', 'upperLimit': '19.6'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '4.0'}, {'value': '-1.6', 'groupId': 'OG002', 'lowerLimit': '-5.7', 'upperLimit': '2.4'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.7'}]}]}, {'title': 'Change at Cycle 29/Day 1 (n=2,5,2,3)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '-26.5', 'upperLimit': '32.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '2.2'}, {'value': '-1.3', 'groupId': 'OG002', 'lowerLimit': '-15.0', 'upperLimit': '12.5'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '-0.4', 'upperLimit': '3.0'}]}]}, {'title': 'Change at Cycle 31/Day 1 (n=1,5,2,2)', 'categories': [{'measurements': [{'value': '4.5', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '1.0'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-26.6', 'upperLimit': '26.4'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '-3.1', 'upperLimit': '5.4'}]}]}, {'title': 'Change at Cycle 33/Day 1 (n=1,3,2,1)', 'categories': [{'measurements': [{'value': '4.5', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-4.4', 'upperLimit': '3.9'}, {'value': '-0.8', 'groupId': 'OG002', 'lowerLimit': '-29.3', 'upperLimit': '27.8'}, {'value': '0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 35/Day 1 (n=0,4,1,1 )', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '1.2'}, {'value': '-1.2', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 37/Day 1 (n=0,4,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '1.2'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 39/Day 1 (n=0,2,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '-0.3'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 41/Day 1 (n=0,2,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '2.0'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.5', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 43/Day 1 (n=0,1,0,1)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.8', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 45/Day 1 (n=0,0,0,1 )', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 47/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.2', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 49/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 51/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 53/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.2', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 55/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.3', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 57/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 59/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.2', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 61/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 63/Day 1 (n=0,0,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at Cycle 65/Day 1 (n=0,1,0,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.2', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not analyzed as no participants were evaluable for the particular cycle.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Change at end of treatment (n=21,29,26,21)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.6'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.8'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal', 'description': 'Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' is number of participants analyzed at specific time point for each treatment arm respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'FG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'FG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'FG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Discontinued by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Axitinib + FOLFIRI', 'description': 'Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m\\^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m\\^2 (or levo-leucovarin \\[l-LV\\] 200 mg /m\\^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'BG001', 'title': 'Bevacizumab + FOLFIRI', 'description': 'Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m\\^2 90 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'BG002', 'title': 'Axitinib + FOLFOX', 'description': 'Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'BG003', 'title': 'Bevacizumab + FOLFOX', 'description': 'Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m\\^2 120 minutes IV infusion, concurrently with LV 400 mg/m\\^2 (or l-LV 200 mg /m\\^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m\\^2 IV bolus injection and a subsequent 5-FU 2400 mg/m\\^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 44 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}]}, {'title': 'Greater than and equal to 65 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2008-02-01', 'resultsFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-28', 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks', 'description': 'Time in months from start of study treatment 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) divided by 30.4. 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").'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline until death or up to 1 year after the randomization of last participant', 'description': 'Time in months from the start of study treatment 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) divided by 30.4. 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': 'Percentage of Participants With Objective Response (OR)', 'timeFrame': 'Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks', 'description': 'Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks', 'description': 'Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. 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) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.'}, {'measure': 'Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal', 'timeFrame': 'Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal', 'description': 'Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.'}, {'measure': 'Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal', 'timeFrame': 'Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal', 'description': 'Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061034&StudyName=A%20Study%20Combining%20FOLFOX%20or%20FOLFIRI%20with%20AG-013736%20or%20Bevacizumab%20%28Avastin%29%20in%20Patients%20with%20Metastatic%20Colorectal%20Cancer%20After%20Failur', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically documented colorectal cancer plus one of the following:\n* Failure of one prior irinotecan- or oxaliplatin-containing regimen, or\n* Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.\n\nExclusion Criteria:\n\n* Prior treatment in first line metastatic setting with more than one regimen\n* Prior irradiation of more than 25% of bone marrow.'}, 'identificationModule': {'nctId': 'NCT00615056', 'briefTitle': 'A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen', 'orgStudyIdInfo': {'id': 'A4061034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Bevacizumab (avastin)', 'interventionNames': ['Drug: Bevacizumab (avastin)', 'Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'AG-013736 (axitinib)', 'interventionNames': ['Drug: AG-013736 (axitinib)', 'Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'AG-013736 (axitinib)', 'interventionNames': ['Drug: AG-013736 (axitinib)', 'Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D', 'description': 'bevacizumab (avastin)', 'interventionNames': ['Drug: Bevacizumab (avastin)', 'Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])']}], 'interventions': [{'name': 'Bevacizumab (avastin)', 'type': 'DRUG', 'description': 'Bevacizumab intravenous \\[IV\\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.', 'armGroupLabels': ['B']}, {'name': 'FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])', 'type': 'DRUG', 'description': 'Irinotecan (180 mg/m²) intravenous infusion \\[IV\\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \\[IV\\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \\[IV\\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.', 'armGroupLabels': ['B']}, {'name': 'AG-013736 (axitinib)', 'type': 'DRUG', 'description': 'Axitinib is given at a starting dose of 5 mg twice daily \\[BID\\] continuous dosing until disease progression, intolerance or withdrawal of consent.', 'armGroupLabels': ['C']}, {'name': 'FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])', 'type': 'DRUG', 'description': 'Oxaliplatin (85 mg/m²) intravenous infusion \\[IV\\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \\[IV\\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.', 'armGroupLabels': ['C']}, {'name': 'AG-013736 (axitinib)', 'type': 'DRUG', 'description': 'Axitinib is given at a starting dose of 5 mg twice daily \\[BID\\] continuous dosing until disease progression, intolerance or withdrawal of consent.', 'armGroupLabels': ['A']}, {'name': 'FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])', 'type': 'DRUG', 'description': 'Irinotecan (180 mg/m²) intravenous infusion \\[IV\\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \\[IV\\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks 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