{"eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":12,"description":"Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + (M7824 (MSB0011359C) + N-803 (Anktiva) (Triple Therapy).\n\nCV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year.\n\nMSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a \"flat\" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.\n\nN-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B.","id":"EG000","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":2,"seriousNumAtRisk":12,"title":"Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)"},{"deathsNumAffected":5,"deathsNumAtRisk":8,"description":"Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + (NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12.\n\nCV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D1) and D15. Starting on D29, FPV-CV301 (1 x 10\\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year.\n\nMSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a \"flat\" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.\n\nN-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B.\n\nNHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.","id":"EG001","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":4,"seriousNumAtRisk":8,"title":"Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation"},{"deathsNumAffected":4,"deathsNumAtRisk":6,"description":"Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); dose escalation of NHS-IL12.\n\nCV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and FPV-CV301. MVA-BN-CV301 (4 x 10\\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year.\n\nMSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a \"flat\" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.\n\nN-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B.\n\nNHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.","id":"EG002","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation"},{"deathsNumAffected":3,"deathsNumAtRisk":6,"description":"Carcinoembryonic antigen (CEA)/Mucin-1 (MUC-1) Vaccines + M7824 (MSB0011359C) + N-803 (Anktiva) + NHS-IL12 (M9241) (Quadruple Therapy); fixed dose of NHS-IL12.\n\nCV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year.\n\nMSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a \"flat\" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.\n\nN-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B.\n\nNHS-IL12: NHS-IL12 will be given via subcutaneous injection at a dose of 8 mcg/kg every 4 weeks or 16 mcg/kg for the first 4 injections and 8 mcg/kg thereafter on Arms 2A and 2B.","id":"EG003","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"title":"Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":12,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12,"numEvents":10},{"groupId":"EG001","numAffected":7,"numAtRisk":8,"numEvents":19},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":4},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12,"numEvents":7},{"groupId":"EG001","numAffected":5,"numAtRisk":8,"numEvents":10},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bladder infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cardiac troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":6,"numEvents":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Eye disorders - Other, conjunctival hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":4},{"groupId":"EG002","numAffected":5,"numAtRisk":6,"numEvents":7},{"groupId":"EG003","numAffected":3,"numAtRisk":6,"numEvents":4}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":12,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":12,"numEvents":20},{"groupId":"EG001","numAffected":7,"numAtRisk":8,"numEvents":22},{"groupId":"EG002","numAffected":6,"numAtRisk":6,"numEvents":15},{"groupId":"EG003","numAffected":6,"numAtRisk":6,"numEvents":15}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, Epistaxis, nose bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, MUCOSAL BLEEDING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Mucosal bleeding, epistaxis - intermittent","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Mucosal bleeding, oral hemorrhage - intermittent when brushing teeth; expected","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Mucosal bleeding, oral hemorrhage; mild bleeding when brushing teeth","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Mucosal bleeding, epistaxis intermittent - blood tinge when blowing nose","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, Mucosal bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Mucosal bleeding, hemorrhoidal hemorrhage","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"General disorders and administration site conditions - Other, 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