{"description":"The severity of AE will be determined using CTCAE version 3.0","eventGroups":[{"deathsNumAffected":55,"deathsNumAtRisk":86,"description":"Erlotinib (Tarceva)150 mg /day\n\nPatients will receive treatment until disease progression or unacceptable toxicity.\n\nFor all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib\n\nErlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.\n\nFor all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib","id":"EG000","otherNumAffected":70,"otherNumAtRisk":86,"seriousNumAffected":27,"seriousNumAtRisk":86,"title":"A: Erlotinib Group"},{"deathsNumAffected":54,"deathsNumAtRisk":87,"description":"4 cycles of Chemotherapy:\n\nCisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.\n\n3 week cycles of standard intravenous chemotherapy\n\n* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or\n* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8\n\nPatients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:\n\n* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or\n* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8\n\nPatients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.","id":"EG001","otherNumAffected":65,"otherNumAtRisk":87,"seriousNumAffected":25,"seriousNumAtRisk":87,"title":"B: Standard Chemotherapy Group"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General 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disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":86,"numEvents":12},{"groupId":"EG001","numAffected":15,"numAtRisk":87,"numEvents":15}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":86,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":87,"numEvents":5}],"term":"Aminotransferase rise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":86,"numEvents":8},{"groupId":"EG001","numAffected":12,"numAtRisk":87,"numEvents":12}],"term":"Neuropathy"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":87,"numEvents":3}],"term":"Respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":86,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Pyelonephritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Subcutaneous abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Upper respiratory tract 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effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":86,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":86,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":87,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Gastrointestinal toxicity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Sigmoiditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":86,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":87,"numEvents":4}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":87,"numEvents":3}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Lymphadenopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":87,"numEvents":2}],"term":"Cerebrovascular accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Ischaemic stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Polyneuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":86,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Cardiac tamponade"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Cardiac failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Pericarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Hepatotoxicity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Hyperbilirubinaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":86,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":87,"numEvents":0}],"term":"Femoral neck fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":87,"numEvents":1}],"term":"Confusional state"}],"timeFrame":"36 months"}