{"description":"One participant who was randomized into FOLFIRI + Placebo arm received Ramucirumab dose by mistake. For safety analysis of adverse events, this participant was categorized into FOLFIRI + Ramucirumab arm.","eventGroups":[{"description":"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.\n\nRamucirumab: 8 mg/kg administered intravenously.\n\nIrinotecan: 180 mg/m\\^2 administered intravenously.\n\nFolinic Acid: 400 mg/m\\^2 administered intravenously.\n\n5-Fluorouracil: 400 mg/m\\^2 bolus immediately followed by 2400 mg/m\\^2 continuous infusion.","id":"EG000","otherNumAffected":518,"otherNumAtRisk":529,"seriousNumAffected":198,"seriousNumAtRisk":529,"title":"FOLFIRI + Ramucirumab"},{"description":"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.\n\nPlacebo: Administered intravenously.\n\nIrinotecan: 180 mg/m\\^2 administered intravenously.\n\nFolinic Acid: 400 mg/m\\^2 administered intravenously.\n\n5-Fluorouracil: 400 mg/m\\^2 bolus immediately followed by 2400 mg/m\\^2 continuous infusion.","id":"EG001","otherNumAffected":510,"otherNumAtRisk":528,"seriousNumAffected":175,"seriousNumAtRisk":528,"title":"FOLFIRI + Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":93,"numAtRisk":529,"numEvents":225},{"groupId":"EG001","numAffected":117,"numAtRisk":528,"numEvents":270}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":183,"numAtRisk":529,"numEvents":510},{"groupId":"EG001","numAffected":131,"numAtRisk":528,"numEvents":259}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":529,"numEvents":177},{"groupId":"EG001","numAffected":42,"numAtRisk":528,"numEvents":82}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":529,"numEvents":26},{"groupId":"EG001","numAffected":27,"numAtRisk":528,"numEvents":29}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":529,"numEvents":178},{"groupId":"EG001","numAffected":123,"numAtRisk":528,"numEvents":181}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":157,"numAtRisk":529,"numEvents":227},{"groupId":"EG001","numAffected":132,"numAtRisk":528,"numEvents":196}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":315,"numAtRisk":529,"numEvents":881},{"groupId":"EG001","numAffected":271,"numAtRisk":528,"numEvents":798}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":529,"numEvents":28},{"groupId":"EG001","numAffected":27,"numAtRisk":528,"numEvents":32}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":529,"numEvents":33},{"groupId":"EG001","numAffected":6,"numAtRisk":528,"numEvents":7}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":265,"numAtRisk":529,"numEvents":650},{"groupId":"EG001","numAffected":274,"numAtRisk":528,"numEvents":715}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":529,"numEvents":35},{"groupId":"EG001","numAffected":13,"numAtRisk":528,"numEvents":16}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":166,"numAtRisk":529,"numEvents":380},{"groupId":"EG001","numAffected":113,"numAtRisk":528,"numEvents":235}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":151,"numAtRisk":529,"numEvents":299},{"groupId":"EG001","numAffected":143,"numAtRisk":528,"numEvents":309}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":529,"numEvents":228},{"groupId":"EG001","numAffected":62,"numAtRisk":528,"numEvents":168}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":254,"numAtRisk":529,"numEvents":645},{"groupId":"EG001","numAffected":225,"numAtRisk":528,"numEvents":588}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":529,"numEvents":97},{"groupId":"EG001","numAffected":38,"numAtRisk":528,"numEvents":104}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":91,"numAtRisk":529,"numEvents":218},{"groupId":"EG001","numAffected":52,"numAtRisk":528,"numEvents":92}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":118,"numAtRisk":529,"numEvents":148},{"groupId":"EG001","numAffected":50,"numAtRisk":528,"numEvents":59}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":529,"numEvents":135},{"groupId":"EG001","numAffected":61,"numAtRisk":528,"numEvents":93}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":529,"numEvents":44},{"groupId":"EG001","numAffected":22,"numAtRisk":528,"numEvents":25}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":529,"numEvents":43},{"groupId":"EG001","numAffected":21,"numAtRisk":528,"numEvents":35}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":529,"numEvents":59},{"groupId":"EG001","numAffected":19,"numAtRisk":528,"numEvents":59}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":529,"numEvents":57},{"groupId":"EG001","numAffected":18,"numAtRisk":528,"numEvents":42}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":529,"numEvents":66},{"groupId":"EG001","numAffected":27,"numAtRisk":528,"numEvents":57}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":137,"numAtRisk":529,"numEvents":437},{"groupId":"EG001","numAffected":115,"numAtRisk":528,"numEvents":278}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":529,"numEvents":232},{"groupId":"EG001","numAffected":36,"numAtRisk":528,"numEvents":59}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":529,"numEvents":124},{"groupId":"EG001","numAffected":46,"numAtRisk":528,"numEvents":69}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":529,"numEvents":146},{"groupId":"EG001","numAffected":51,"numAtRisk":528,"numEvents":136}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":203,"numAtRisk":529,"numEvents":382},{"groupId":"EG001","numAffected":149,"numAtRisk":528,"numEvents":359}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":529,"numEvents":46},{"groupId":"EG001","numAffected":26,"numAtRisk":528,"numEvents":32}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":529,"numEvents":59},{"groupId":"EG001","numAffected":13,"numAtRisk":528,"numEvents":20}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":529,"numEvents":65},{"groupId":"EG001","numAffected":38,"numAtRisk":528,"numEvents":72}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":529,"numEvents":38},{"groupId":"EG001","numAffected":22,"numAtRisk":528,"numEvents":26}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":529,"numEvents":54},{"groupId":"EG001","numAffected":48,"numAtRisk":528,"numEvents":128}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":529,"numEvents":58},{"groupId":"EG001","numAffected":19,"numAtRisk":528,"numEvents":25}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":529,"numEvents":46},{"groupId":"EG001","numAffected":33,"numAtRisk":528,"numEvents":51}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":529,"numEvents":57},{"groupId":"EG001","numAffected":39,"numAtRisk":528,"numEvents":57}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":529,"numEvents":114},{"groupId":"EG001","numAffected":41,"numAtRisk":528,"numEvents":69}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":529,"numEvents":57},{"groupId":"EG001","numAffected":38,"numAtRisk":528,"numEvents":49}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":529,"numEvents":51},{"groupId":"EG001","numAffected":54,"numAtRisk":528,"numEvents":84}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":94,"numAtRisk":529,"numEvents":227},{"groupId":"EG001","numAffected":30,"numAtRisk":528,"numEvents":40}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":529,"numEvents":88},{"groupId":"EG001","numAffected":46,"numAtRisk":528,"numEvents":60}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":529,"numEvents":32},{"groupId":"EG001","numAffected":5,"numAtRisk":528,"numEvents":6}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":529,"numEvents":86},{"groupId":"EG001","numAffected":51,"numAtRisk":528,"numEvents":70}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":182,"numAtRisk":529,"numEvents":254},{"groupId":"EG001","numAffected":80,"numAtRisk":528,"numEvents":99}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":529,"numEvents":81},{"groupId":"EG001","numAffected":17,"numAtRisk":528,"numEvents":22}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":156,"numAtRisk":529,"numEvents":198},{"groupId":"EG001","numAffected":168,"numAtRisk":528,"numEvents":191}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 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