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(Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Urinary tract infection"}],"timeFrame":"Adverse events were collected beginning at informed consent, including pre-treatment adverse events, and through 30 days after the last dose of study drug, up to 16 months. Deaths were collected up to 27 months"}