{"description":"The severity of AE will be determined using CTCAE version 4.0","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":46,"description":"Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months\n\nNivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months\n\nPaclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W\n\nCarboplatin AUC 6: Carboplatin AUC 6 IV Q3W","id":"EG000","otherNumAffected":43,"otherNumAtRisk":46,"seriousNumAffected":3,"seriousNumAtRisk":46,"title":"Arm 1"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":46,"numEvents":51}],"term":"Asthenia or fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":46,"numEvents":17}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":46,"numEvents":20}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":46,"numEvents":15}],"term":"Neurotoxicity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":46,"numEvents":19}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":46,"numEvents":18}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":46,"numEvents":40}],"term":"Skin disorders (rash)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":46,"numEvents":14}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":46,"numEvents":12}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":46,"numEvents":16}],"term":"Decreased appetite or anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":46,"numEvents":12}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":46,"numEvents":12}],"term":"Paraesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":46,"numEvents":20}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":46,"numEvents":7}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5}],"term":"Increased aminotransferases"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":6}],"term":"Increased serum amylase"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3}],"term":"Increased creatinine level"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":46,"numEvents":7}],"term":"Increased lipase"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"12.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2}],"term":"Increased lipase"}],"timeFrame":"40 months"}