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(4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":23,"numEvents":1}],"term":"dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":23,"numEvents":0}],"term":"acute kidney injury"}],"timeFrame":"Adverse Events were collected for each subject from time of start of study therapy through 30 days following last dose of study therapy. Results reported here reflect 15 months following the start of the final subject on study therapy"}