Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-06-24 @ 11:26 PM
Study NCT ID:
NCT00069095
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2003-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, '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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '+41 61 6878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 2 years 6 months', 'description': 'Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Xelox', 'description': 'Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.', 'otherNumAtRisk': 316, 'otherNumAffected': 310, 'seriousNumAtRisk': 316, 'seriousNumAffected': 117}, {'id': 'EG001', 'title': 'Folfox-4', 'description': 'Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.', 'otherNumAtRisk': 313, 'otherNumAffected': 310, 'seriousNumAtRisk': 313, 'seriousNumAffected': 120}, {'id': 'EG002', 'title': 'Xelox+P', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \\[volume equivalent to 7.5 mg/kg BV\\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.', 'otherNumAtRisk': 339, 'otherNumAffected': 330, 'seriousNumAtRisk': 339, 'seriousNumAffected': 121}, {'id': 'EG003', 'title': 'Folfox-4+P', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.', 'otherNumAtRisk': 336, 'otherNumAffected': 331, 'seriousNumAtRisk': 336, 'seriousNumAffected': 128}, {'id': 'EG004', 'title': 'Xelox+BV', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.', 'otherNumAtRisk': 353, 'otherNumAffected': 348, 'seriousNumAtRisk': 353, 'seriousNumAffected': 131}, {'id': 'EG005', 'title': 'Folfox-4+BV', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.', 'otherNumAtRisk': 341, 'otherNumAffected': 335, 'seriousNumAtRisk': 341, 'seriousNumAffected': 146}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 207}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 186}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 208}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 197}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 210}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 218}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 194}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 208}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 209}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 204}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 230}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 215}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 123}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 134}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 127}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 160}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 127}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Stomatitis All', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 130}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 101}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 141}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 99}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 68}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 101}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 86}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 89}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 85}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 81}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 30}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 32}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 126}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 127}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 133}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 135}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 70}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 64}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 72}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 70}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 46}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 50}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 29}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 53}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 62}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 56}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 49}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 152}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 118}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 140}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 133}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 135}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 90}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 77}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 97}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 84}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 66}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Temperature Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 23}, {'groupId': 'EG003', 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'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Endoscopic retrograde cholangiopancreatography', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Angioneurotic oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vascular purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Retinal vascular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Amaurosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Colostomy closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Ileostomy closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vaginal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 353, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000', 'lowerLimit': '245', 'upperLimit': '268'}, {'value': '241', 'groupId': 'OG001', 'lowerLimit': '229', 'upperLimit': '254'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.05', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.18', 'groupDescription': "Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \\>/= 1.23 versus H1: HRA/B \\< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The eligible patient population (EPP) excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '304.0', 'groupId': 'OG000', 'lowerLimit': '281', 'upperLimit': '319'}, {'value': '261.0', 'groupId': 'OG001', 'lowerLimit': '246', 'upperLimit': '276'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.22', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.42', 'groupDescription': "Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \\>/= 1.23 versus H1: HRA/B \\< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '259.0', 'groupId': 'OG000', 'lowerLimit': '244', 'upperLimit': '278'}, {'value': '335.0', 'groupId': 'OG001', 'lowerLimit': '310', 'upperLimit': '363'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.70', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.83', 'groupDescription': 'Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '268.0', 'groupId': 'OG000', 'lowerLimit': '252', 'upperLimit': '290'}, {'value': '234.0', 'groupId': 'OG001', 'lowerLimit': '221', 'upperLimit': '251'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.24', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.44', 'groupDescription': 'HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "Fewer events were expected in the 'on-treatment analysis', thus leading to reduced power. No formal statistical testing was therefore applied."}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '241.0', 'groupId': 'OG000', 'lowerLimit': '227', 'upperLimit': '254'}, {'value': '316.0', 'groupId': 'OG001', 'lowerLimit': '294', 'upperLimit': '338'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.63', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.75', 'groupDescription': 'Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '260.0', 'groupId': 'OG000', 'lowerLimit': '247', 'upperLimit': '270'}, {'value': '244.0', 'groupId': 'OG001', 'lowerLimit': '230', 'upperLimit': '255'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.03', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.15', 'groupDescription': "Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \\>/= 1.23 versus H1: HRA/B \\< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '245.0', 'groupId': 'OG000', 'lowerLimit': '230', 'upperLimit': '258'}, {'value': '287.0', 'groupId': 'OG001', 'lowerLimit': '276', 'upperLimit': '300'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.83', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.95', 'groupDescription': 'Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '549.0', 'groupId': 'OG000', 'lowerLimit': '528', 'upperLimit': '576'}, {'value': '577.0', 'groupId': 'OG001', 'lowerLimit': '535', 'upperLimit': '615'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.97', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.14', 'groupDescription': 'HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \\[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\\] were therefore applied to OS as well.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '574.0', 'groupId': 'OG000', 'lowerLimit': '537', 'upperLimit': '592'}, {'value': '551.0', 'groupId': 'OG001', 'lowerLimit': '528', 'upperLimit': '635'}]}]}], 'analyses': [{'pValue': '0.1921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.89', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.09', 'groupDescription': 'Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented together with the 97.5% confidence interval.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'PRIMARY', 'title': 'PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '244.0', 'groupId': 'OG000', 'lowerLimit': '230', 'upperLimit': '257'}, {'value': '285.0', 'groupId': 'OG001', 'lowerLimit': '271', 'upperLimit': '297'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.83', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.95', 'groupDescription': 'Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000'}, {'value': '46.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.89', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.09', 'groupDescription': 'Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \\</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \\> 0.66, where OR denotes Odds ratio.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was concluded if the lower limit of this confidence interval is above 0.66.'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.90', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.14', 'groupDescription': 'Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \\</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \\> 1.0. The test used a two-sided significance level of 2.5%.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '37.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.94', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.16', 'groupDescription': 'Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \\</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \\> 0.66', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.00', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.28', 'groupDescription': 'Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \\</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \\> 1.0. The test used a two-sided significance level of 2.5%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '990', 'groupId': 'OG000'}, {'value': '1008', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'title': 'General Approach', 'categories': [{'measurements': [{'value': '191.0', 'groupId': 'OG000', 'lowerLimit': '183', 'upperLimit': '202'}, {'value': '179.0', 'groupId': 'OG001', 'lowerLimit': '171', 'upperLimit': '187'}]}]}, {'title': 'On-treatment Approach', 'categories': [{'measurements': [{'value': '190.0', 'groupId': 'OG000', 'lowerLimit': '182', 'upperLimit': '200'}, {'value': '176.0', 'groupId': 'OG001', 'lowerLimit': '170', 'upperLimit': '185'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.08', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.20', 'groupDescription': 'General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal statistical testing was done.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.10', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.23', 'groupDescription': 'On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '694', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'title': 'General Approach', 'categories': [{'measurements': [{'value': '183.0', 'groupId': 'OG000', 'lowerLimit': '176', 'upperLimit': '198'}, {'value': '209.0', 'groupId': 'OG001', 'lowerLimit': '199', 'upperLimit': '220'}]}]}, {'title': 'On-treatment Approach', 'categories': [{'measurements': [{'value': '182.0', 'groupId': 'OG000', 'lowerLimit': '175', 'upperLimit': '196'}, {'value': '208.0', 'groupId': 'OG001', 'lowerLimit': '198', 'upperLimit': '220'}]}]}], 'analyses': [{'pValue': '0.0030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.84', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.96', 'groupDescription': 'General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.81', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.92', 'groupDescription': 'On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'title': 'Week 1-6', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Week 7-12', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}, {'title': 'Week 13-18', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Week 19-24', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Week 25-30', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 31-36', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 37-42', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 49-54', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 54', 'description': 'For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'title': 'Week 1-6', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Week 7-12', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}, {'title': 'Week 13-18', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Week 19-24', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 25-30', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 31-36', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 37-42', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 49-54', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 54', 'description': 'For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '239.0', 'groupId': 'OG000', 'lowerLimit': '225', 'upperLimit': '256'}, {'value': '226.0', 'groupId': 'OG001', 'lowerLimit': '211', 'upperLimit': '246'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.02', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.22', 'groupDescription': 'HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal statistical testing was performed for duration of overall response.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '225.0', 'groupId': 'OG000', 'lowerLimit': '217', 'upperLimit': '240'}, {'value': '257.0', 'groupId': 'OG001', 'lowerLimit': '241', 'upperLimit': '278'}]}]}], 'analyses': [{'pValue': '0.0307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.82', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.01', 'groupDescription': 'Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}, {'type': 'SECONDARY', 'title': 'Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '967', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).\n2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).'}, {'id': 'OG001', 'title': 'XELOX/XELOX+P/XELOX+BV', 'description': 'Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -\n\n1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).\n3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '347.0', 'groupId': 'OG000', 'lowerLimit': '196', 'upperLimit': '403'}, {'value': '589.0', 'comment': 'The estimate is Not Available due to insufficient follow-up time to estimate the missing parameter.', 'groupId': 'OG001', 'lowerLimit': '270', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.35', 'ciLowerLimit': '0.09', 'ciUpperLimit': '1.39', 'groupDescription': 'HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal statistical testing was done.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.'}, {'type': 'SECONDARY', 'title': 'Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFOX-4+P/XELOX+P', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).'}, {'id': 'OG001', 'title': 'FOLFOX-4+BV/XELOX+BV', 'description': 'Participants from the 2x2 factorial part of the study including the following groups -\n\n1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).\n2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '403.0', 'comment': 'The estimate is Not Available due to insufficient follow-up time to estimate the missing parameter.', 'groupId': 'OG000', 'lowerLimit': '228', 'upperLimit': 'NA'}, {'value': '386.0', 'groupId': 'OG001', 'lowerLimit': '133', 'upperLimit': '386'}]}]}], 'analyses': [{'pValue': '0.8207', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.20', 'ciLowerLimit': '0.20', 'ciUpperLimit': '7.05', 'groupDescription': 'Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \\[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\\] was presented.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who provided written informed consent.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xelox', 'description': 'Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'FG001', 'title': 'Folfox-4', 'description': 'Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'FG002', 'title': 'Xelox+P', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \\[volume equivalent to 7.5 mg/kg BV\\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'FG003', 'title': 'Folfox-4+P', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'FG004', 'title': 'Xelox+BV', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'FG005', 'title': 'Folfox-4+BV', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}], 'periods': [{'title': 'Primary Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '317'}, {'groupId': 'FG001', 'numSubjects': '317'}, {'groupId': 'FG002', 'numSubjects': '350'}, {'groupId': 'FG003', 'numSubjects': '351'}, {'groupId': 'FG004', 'numSubjects': '350'}, {'groupId': 'FG005', 'numSubjects': '349'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '48'}, {'groupId': 'FG005', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '302'}, {'groupId': 'FG002', 'numSubjects': '314'}, {'groupId': 'FG003', 'numSubjects': '320'}, {'groupId': 'FG004', 'numSubjects': '302'}, {'groupId': 'FG005', 'numSubjects': '301'}]}], 'dropWithdraws': [{'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Admin/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '48'}, {'groupId': 'FG005', 'numSubjects': '42'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '109'}, {'groupId': 'FG005', 'numSubjects': '101'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '175'}, {'groupId': 'FG003', 'numSubjects': '154'}, {'groupId': 'FG004', 'numSubjects': '101'}, {'groupId': 'FG005', 'numSubjects': '102'}]}, {'type': 'Refused treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '27'}]}, {'type': 'Withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Other Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Violation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '5'}]}]}, {'title': 'Post-study Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG002', 'numSubjects': '21'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG003', 'numSubjects': '17'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG004', 'numSubjects': '36'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG005', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Missing reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Eligible for surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Participant refusal/Admin reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Participant had complete response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'More than 21 days delay between cycles', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Investigator decision (enough treatment)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant will start new treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant wanted break from treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant completed treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant had progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant/Physician decision to stop', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Preplanned 6 cycles after surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Follow-up Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG000', 'numSubjects': '284'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG001', 'numSubjects': '299'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG002', 'numSubjects': '298'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG003', 'numSubjects': '299'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG004', 'numSubjects': '278'}, {'comment': 'Participants could enter the follow-up phase even without entering the post-study treatment phase.', 'groupId': 'FG005', 'numSubjects': '272'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '178'}, {'groupId': 'FG003', 'numSubjects': '187'}, {'groupId': 'FG004', 'numSubjects': '186'}, {'groupId': 'FG005', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '206'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '112'}, {'groupId': 'FG004', 'numSubjects': '92'}, {'groupId': 'FG005', 'numSubjects': '101'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '206'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '112'}, {'groupId': 'FG004', 'numSubjects': '92'}, {'groupId': 'FG005', 'numSubjects': '101'}]}]}], 'recruitmentDetails': 'This study was conducted in 32 countries - Australia, Austria, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Mexico, New Zealand, Norway, Panama, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and USA.', 'preAssignmentDetails': 'A total of 2035 participants were randomized to any one of the treatment groups in the study (634 participants in the initial 2-arm part and 1401 participants in the 2x2 factorial part of the study), but only 2034 received study treatment as 1 participant was enrolled twice in the study at 2 study centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}, {'value': '351', 'groupId': 'BG003'}, {'value': '350', 'groupId': 'BG004'}, {'value': '349', 'groupId': 'BG005'}, {'value': '2034', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Xelox', 'description': 'Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'BG001', 'title': 'Folfox-4', 'description': 'Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'BG002', 'title': 'Xelox+P', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \\[volume equivalent to 7.5 mg/kg BV\\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'BG003', 'title': 'Folfox-4+P', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'BG004', 'title': 'Xelox+BV', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'BG005', 'title': 'Folfox-4+BV', 'description': 'Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\\^2 iv for 2 hours followed by fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '10.76', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '12.14', 'groupId': 'BG002'}, {'value': '58.8', 'spread': '10.87', 'groupId': 'BG003'}, {'value': '59.7', 'spread': '11.28', 'groupId': 'BG004'}, {'value': '59.7', 'spread': '10.74', 'groupId': 'BG005'}, {'value': '59.7', 'spread': '11.14', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}, {'value': '144', 'groupId': 'BG005'}, {'value': '827', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}, {'value': '213', 'groupId': 'BG004'}, {'value': '205', 'groupId': 'BG005'}, {'value': '1207', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics were described for the Intent-to-treat (ITT) population.This population included all randomized participants who provided written informed consent.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2035}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2003-09-15', 'resultsFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2003-09-17', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-11', 'studyFirstPostDateStruct': {'date': '2003-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.'}, {'measure': 'PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}], 'secondaryOutcomes': [{'measure': 'PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.'}, {'measure': 'PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}, {'measure': 'Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'Baseline until disease progression or death, approximately 2 years 6 months', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}, {'measure': 'Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}, {'measure': 'BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}, {'measure': 'Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.'}, {'measure': 'Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.'}, {'measure': 'Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'Week 1 to Week 54', 'description': 'For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'Week 1 to Week 54', 'description': 'For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}, {'measure': 'Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}, {'measure': 'Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.'}, {'measure': 'Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone', 'timeFrame': 'From baseline until disease progression/recurrence, approximately 2 years 6 months', 'description': 'For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.'}]}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m\\^2 orally \\[po\\] twice a day \\[bid\\] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil \\[5-FU\\] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).', 'detailedDescription': 'This study was conducted in 2 parts: An initial 2-arm part in which patients were randomized to 1 of 2 different treatment groups (XELOX or FOLFOX-4), and a subsequent 2 x 2 factorial part, added to the study through a protocol amendment, in which additional patients were randomized into one of 4 different treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, or FOLFOX-4 + bevacizumab). Due to the comparison of the oral agent capecitabine with bolus and infused fluorouracil, the study was not blinded with respect to these 2 treatments. The study was double-blind with regard to the administration of bevacizumab, ie, there was a placebo control for bevacizumab in the second part of the study.\n\nThe study consisted of 3 phases, a Primary Study Treatment Phase, a Post-Study Treatment Phase, and a Follow-Up Phase.\n\nPrimary Study Treatment Phase\n\nPatients were to receive up to 16 cycles (2-arm part of the study) or 24 cycles (4-arm part of the study) of treatment during the Primary Study Treatment Phase (48 weeks).\n\nPost-Study Treatment Phase\n\nPatients who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Patients who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the patient withdrew consent.\n\nFollow-up Phase\n\nPatients who terminated study treatment during the primary or post-study treatment phase were followed until disease progression or death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age.\n* Metastatic colorectal cancer.\n* ≥ 1 target lesion.\n\nExclusion Criteria:\n\n* Previous treatment with oxaliplatin or bevacizumab.\n* Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.\n* Progressive disease during or within 6 months of completion of previous adjuvant therapy.'}, 'identificationModule': {'nctId': 'NCT00069095', 'briefTitle': 'A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'NO16966'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XELOX (oxaliplatin+capecitabine)', 'description': 'Patients in the 2-arm part of the study received oxaliplatin 130 mg/m\\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\\^2 orally twice a day for the first 2 weeks of every 3 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.', 'interventionNames': ['Drug: Oxaliplatin 130 mg/m^2', 'Drug: Capecitabine 1000 mg/m^2', 'Drug: Placebo for bevacizumab 7.5 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'XELOX (oxaliplatin+capecitabine) + bevacizumab', 'description': 'Patients in the 4-arm part of the study received oxaliplatin 130 mg/m\\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\\^2 orally twice a day for the first 2 weeks of every 3 week cycle + bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.', 'interventionNames': ['Drug: Oxaliplatin 130 mg/m^2', 'Drug: Capecitabine 1000 mg/m^2', 'Drug: Bevacizumab 7.5 mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)', 'description': 'Patients in the 2-arm part of the study received oxaliplatin 85 mg/m\\^2 intravenously (iv) + leucovorin 200 mg/m\\^2 iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle.', 'interventionNames': ['Drug: Oxaliplatin 85 mg/m^2', 'Drug: Leucovorin 200 mg/m^2', 'Drug: Fluorouracil 400 mg/m^2', 'Drug: Placebo for bevacizumab 5 mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab', 'description': 'Patients in the 4-arm part of the study received oxaliplatin 85 mg/m\\^2 intravenously (iv) + leucovorin 200 mg/m\\^2 iv + bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m\\^2 bolus injection over 2 to 4 min followed by 600 mg/m\\^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle.', 'interventionNames': ['Drug: Oxaliplatin 85 mg/m^2', 'Drug: Leucovorin 200 mg/m^2', 'Drug: Fluorouracil 400 mg/m^2', 'Drug: Bevacizumab 5 mg/kg']}], 'interventions': [{'name': 'Oxaliplatin 130 mg/m^2', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'description': 'Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.', 'armGroupLabels': ['XELOX (oxaliplatin+capecitabine)', 'XELOX (oxaliplatin+capecitabine) + bevacizumab']}, {'name': 'Capecitabine 1000 mg/m^2', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine was taken within 30 min after the end of breakfast and dinner.', 'armGroupLabels': ['XELOX (oxaliplatin+capecitabine)', 'XELOX (oxaliplatin+capecitabine) + bevacizumab']}, {'name': 'Bevacizumab 7.5 mg/kg', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab was administered in a 30 to 90 min infusion.', 'armGroupLabels': ['XELOX (oxaliplatin+capecitabine) + bevacizumab']}, {'name': 'Placebo for bevacizumab 7.5 mg/kg', 'type': 'DRUG', 'description': 'Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.', 'armGroupLabels': ['XELOX (oxaliplatin+capecitabine)']}, {'name': 'Oxaliplatin 85 mg/m^2', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'description': 'Oxaliplatin 85 mg/m\\^2 was administered simultaneously with leucovorin in a 2 h infusion.', 'armGroupLabels': ['FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)', 'FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab']}, {'name': 'Leucovorin 200 mg/m^2', 'type': 'DRUG', 'description': 'Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\\^2 in a 2 h infusion.', 'armGroupLabels': ['FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)', 'FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab']}, {'name': 'Fluorouracil 400 mg/m^2', 'type': 'DRUG', 'otherNames': ['Efudex'], 'armGroupLabels': ['FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)', 'FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab']}, {'name': 'Bevacizumab 5 mg/kg', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab was administered in a 30 to 90 min infusion.', 'armGroupLabels': ['FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab']}, {'name': 'Placebo for bevacizumab 5 mg/kg', 'type': 'DRUG', 'description': 'Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.', 'armGroupLabels': ['FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '95020', 'city': 'Gilroy', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.00578, 'lon': -121.56828}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 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