{"description":"0 subjects were enrolled in Cohort B","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab\n\nIbrutinib: Ibrutinib, 420mg orally, once daily\n\nDaratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Cohort A - Ibrutinib Naive"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \\<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab\n\nIbrutinib: Ibrutinib, 420mg orally, once daily\n\nDaratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Cohort B - Ibrutinib Response Plateau"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"grade 1","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Infusion-related reaction","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Infusion related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Scratchy Throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"ALT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"AST increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Malaise- flu like symptoms"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Elevated ALT/AST"}],"timeFrame":"3 months"}