{"description":"Serious AE:\n\nEligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).\n\nOther AE:\n\nEligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).","eventGroups":[{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"EG000","otherNumAffected":23,"otherNumAtRisk":38,"seriousNumAffected":1,"seriousNumAtRisk":38,"title":"Arm I (Patients Off-therapy Before Callback-Induction Only)"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"EG001","otherNumAffected":341,"otherNumAtRisk":380,"seriousNumAffected":2,"seriousNumAtRisk":380,"title":"Arm II (RER With CR [ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"EG002","otherNumAffected":334,"otherNumAtRisk":382,"seriousNumAffected":1,"seriousNumAtRisk":382,"title":"Arm III (RER With CR [ABVE-PC])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"EG003","otherNumAffected":497,"otherNumAtRisk":571,"seriousNumAffected":5,"seriousNumAtRisk":571,"title":"Arm IV (RER With Less Than CR [ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"EG004","otherNumAffected":26,"otherNumAtRisk":36,"seriousNumAffected":1,"seriousNumAtRisk":36,"title":"Arm V (RER With PD)"},{"description":"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \\& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \\& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \\& G-CSF SC beginning on day 3 \\& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCisplatin: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV\n\nDexamethasone: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPre","id":"EG005","otherNumAffected":135,"otherNumAtRisk":153,"seriousNumAffected":2,"seriousNumAtRisk":153,"title":"Arm VI (SER [DECA, ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"EG006","otherNumAffected":133,"otherNumAtRisk":152,"seriousNumAffected":1,"seriousNumAtRisk":152,"title":"Arm VII (SER [ABVE-PC, IFRT])"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":38,"numEvents":4},{"groupId":"EG001","numAffected":196,"numAtRisk":380,"numEvents":196},{"groupId":"EG002","numAffected":162,"numAtRisk":382,"numEvents":162},{"groupId":"EG003","numAffected":245,"numAtRisk":571,"numEvents":245},{"groupId":"EG004","numAffected":12,"numAtRisk":36,"numEvents":12},{"groupId":"EG005","numAffected":85,"numAtRisk":153,"numEvents":85},{"groupId":"EG006","numAffected":63,"numAtRisk":152,"numEvents":63}],"term":"Anemia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":50,"numAtRisk":380,"numEvents":50},{"groupId":"EG002","numAffected":35,"numAtRisk":382,"numEvents":35},{"groupId":"EG003","numAffected":57,"numAtRisk":571,"numEvents":57},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":31,"numAtRisk":153,"numEvents":31},{"groupId":"EG006","numAffected":20,"numAtRisk":152,"numEvents":20}],"term":"Blood and lymphatic system disorders - Other, specify"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Disseminated intravascular coagulation"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":38,"numEvents":5},{"groupId":"EG001","numAffected":111,"numAtRisk":380,"numEvents":111},{"groupId":"EG002","numAffected":99,"numAtRisk":382,"numEvents":99},{"groupId":"EG003","numAffected":128,"numAtRisk":571,"numEvents":128},{"groupId":"EG004","numAffected":3,"numAtRisk":36,"numEvents":3},{"groupId":"EG005","numAffected":45,"numAtRisk":153,"numEvents":45},{"groupId":"EG006","numAffected":31,"numAtRisk":152,"numEvents":31}],"term":"Febrile neutropenia"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":380,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":382,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":571,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":153,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Cardiac disorders - Other, specify"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Left ventricular systolic dysfunction"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":380,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":571,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Sinus tachycardia"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":380,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Supraventricular tachycardia"},{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Hearing impaired"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":382,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Endocrine disorders - Other, specify"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":382,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Blurred vision"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":380,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Eye disorders - Other, specify"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":380,"numEvents":4},{"groupId":"EG002","numAffected":6,"numAtRisk":382,"numEvents":6},{"groupId":"EG003","numAffected":12,"numAtRisk":571,"numEvents":12},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":152,"numEvents":1}],"term":"Abdominal pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":571,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":152,"numEvents":1}],"term":"Anal fistula"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Ascites"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":380,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":5,"numAtRisk":571,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Colitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":380,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":382,"numEvents":4},{"groupId":"EG003","numAffected":2,"numAtRisk":571,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Constipation"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":380,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":382,"numEvents":2},{"groupId":"EG003","numAffected":9,"numAtRisk":571,"numEvents":9},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":153,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Diarrhea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":380,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":571,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Dyspepsia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":571,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Dysphagia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":380,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":382,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":571,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Esophagitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Gastric hemorrhage"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":380,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":571,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Gastrointestinal disorders - Other, specify"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":380,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":382,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":571,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Ileus"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Lower gastrointestinal hemorrhage"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":20,"numAtRisk":380,"numEvents":20},{"groupId":"EG002","numAffected":9,"numAtRisk":382,"numEvents":9},{"groupId":"EG003","numAffected":25,"numAtRisk":571,"numEvents":25},{"groupId":"EG004","numAffected":1,"numAtRisk":36,"numEvents":1},{"groupId":"EG005","numAffected":10,"numAtRisk":153,"numEvents":10},{"groupId":"EG006","numAffected":2,"numAtRisk":152,"numEvents":2}],"term":"Mucositis oral"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":380,"numEvents":6},{"groupId":"EG002","numAffected":5,"numAtRisk":382,"numEvents":5},{"groupId":"EG003","numAffected":21,"numAtRisk":571,"numEvents":21},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":6,"numAtRisk":153,"numEvents":6},{"groupId":"EG006","numAffected":2,"numAtRisk":152,"numEvents":2}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":380,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":382,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":571,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":153,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Pancreatitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":380,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":571,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":152,"numEvents":1}],"term":"Rectal hemorrhage"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":38,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":380,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":382,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":571,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":153,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":152,"numEvents":0}],"term":"Rectal pain"},{"organSystem":"Gastrointestinal 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