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INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"HERPES SIMPLEX REACTIVATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"VASCULAR ACCESS COMPLICATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"LARYNGEAL OBSTRUCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"RESPIRATORY FAILURE"}],"timeFrame":"Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment."}