{"description":"Adverse Events were assessed at the end of every 14 day cycle during treatment, up to 12 cycles.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Avelumab and Cisplatin IV"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":14}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":9}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Proctitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":13}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":7}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":25}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2,"numEvents":9}],"term":"Urinary urgency"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1}],"term":"Sepsis"}],"timeFrame":"Adverse Events were assessed at the end of every 14 day cycle during treatment, up to 12 cycles."}