{"description":"Per protocol; \"Safety data will be summarized for the safety population separately for phase 1 and phase 2 portions by dose level. All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE (v 4.03).\" Since Phase 2 and the subset of Phase I patients who received MTD both received 800 mg daily, these are reported together. Those who received 400 mg daily were reported separately.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Patients receive entospletinib PO either QD or BID on days -7 to -1 (run-in phase) according to dose level 1 (200 mg twice daily). Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of the first cycle, and on day 1 of subsequent cycles. Treatment with obinutuzumab repeats every 28 days for up to 6 cycles and daily treatment with entospletinib continues every 28 days for up to 12 cycles in the absence of disease progression or unexpected toxicity.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Phase 1, Dose 1 (400 mg Entospletinib Daily)"},{"deathsNumAffected":1,"deathsNumAtRisk":17,"description":"Patients receive entospletinib PO either QD or BID on days -7 to -1 (run-in phase) according to dose level 2 (400 mg twice daily). Patients also receive obinutuzumab IV on days 1, 2, 8 and 15 of the first cycle, and on day 1 of subsequent cycles. Treatment with obinutuzumab repeats every 28 days for up to 6 cycles and daily treatment with entospletinib continues every 28 days for up to 12 cycles in the absence of disease progression or unexpected toxicity.","id":"EG001","otherNumAffected":17,"otherNumAtRisk":17,"seriousNumAffected":5,"seriousNumAtRisk":17,"title":"Phase 2 and MTD (800 mg Entospletinib Daily)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":17,"numEvents":11}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":17,"numEvents":13}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Bronchial infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":11,"numAtRisk":17,"numEvents":13}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Nail infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":10},{"groupId":"EG001","numAffected":10,"numAtRisk":17,"numEvents":45}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Otitis externa"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":17,"numEvents":13}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Rhinitis infective"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":17,"numEvents":6}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Tooth infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Tumor lysis syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":7,"numAtRisk":17,"numEvents":17}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Wound infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":17,"numEvents":9}],"term":"Urinary tract infection"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Infusion Related Reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Tumor Lysis Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Interoperative Hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Acute Coronary Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"SARS-COV2 Infection","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Pneumonia","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Infections and infestations - Other, specify"}],"timeFrame":"Up to 45 months. For the participants, the median follow-up time for adverse events was 17 months."}