{"description":"Safety data for this trial was collected in accordance with CTCAE criteria version 4.0","eventGroups":[{"deathsNumAffected":24,"deathsNumAtRisk":32,"description":"Avelumab (an anti-PDL1 antibody) 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days.","id":"EG000","otherNumAffected":31,"otherNumAtRisk":32,"seriousNumAffected":18,"seriousNumAtRisk":32,"title":"Avelumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32,"numEvents":5}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32,"numEvents":5}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":3}],"term":"Mucositis Oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":32,"numEvents":8}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32,"numEvents":7}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":3}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Edema Limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":32,"numEvents":12}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":32,"numEvents":11}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Flu Like Symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":32,"numEvents":7}],"term":"Infusion Related Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Localised Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":5}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":3}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":4}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Alkaline Phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Aspartate Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32,"numEvents":11}],"term":"Platelet Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Weight Loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":32,"numEvents":8}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":32,"numEvents":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":4}],"term":"Pruritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Rash Maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Dacrocystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Immune-mediated colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":32,"numEvents":6}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Edema-groin,scrotum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Lung/skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Infection (blood culture positive)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":32,"numEvents":2}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Rhinitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":32,"numEvents":3}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":32,"numEvents":1}],"term":"Infections and infestations-Other,specify"}],"timeFrame":"Serious and other (not including serious) adverse events were recorded for all patients from the date they started trial treatment until 30 days after they received their last treatment, up to 9 months. Deaths were collected up to 2 years."}