{"description":"Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The \"AE Other\" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.","eventGroups":[{"deathsNumAffected":125,"deathsNumAtRisk":9229,"description":"All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate on days 8 and 29. Patients with DS also receive leucovorin calcium every 12 hours on days 10-11 and 21-32. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 \\[\\> 25% lymphoblasts\\] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.","id":"EG000","otherNumAffected":1776,"otherNumAtRisk":9229,"seriousNumAffected":72,"seriousNumAtRisk":9229,"title":"B-ALL"},{"deathsNumAffected":2,"deathsNumAtRisk":48,"description":"Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).","id":"EG001","otherNumAffected":30,"otherNumAtRisk":48,"seriousNumAffected":0,"seriousNumAtRisk":48,"title":"B-LLy"},{"deathsNumAffected":16,"deathsNumAtRisk":3122,"description":"Consolidation (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34","id":"EG002","otherNumAffected":1037,"otherNumAtRisk":3122,"seriousNumAffected":16,"seriousNumAtRisk":3122,"title":"B-ALL Average Risk"},{"deathsNumAffected":11,"deathsNumAtRisk":224,"description":"Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN \\& IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN \\& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN \\& IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).","id":"EG003","otherNumAffected":191,"otherNumAtRisk":224,"seriousNumAffected":9,"seriousNumAtRisk":224,"title":"Standard Risk With Down Syndrome"},{"deathsNumAffected":0,"deathsNumAtRisk":301,"description":"Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX\\* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1\\&4), d 57 (course 2\\&5), d29 (course 3\\&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. \\*Patients do not receive MTX PO on d w/ IT MTX.","id":"EG004","otherNumAffected":103,"otherNumAtRisk":301,"seriousNumAffected":0,"seriousNumAtRisk":301,"title":"B-ALL Low Risk Arm I (LR-M)"},{"deathsNumAffected":1,"deathsNumAtRisk":302,"description":"Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN \\& IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN \\& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN \\& IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1","id":"EG005","otherNumAffected":143,"otherNumAtRisk":302,"seriousNumAffected":0,"seriousNumAtRisk":302,"title":"B-ALL Low Risk Arm II (LR-C)"},{"deathsNumAffected":7,"deathsNumAtRisk":600,"description":"Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1+P8:W8-84; and IT MTX d 1","id":"EG006","otherNumAffected":180,"otherNumAtRisk":600,"seriousNumAffected":7,"seriousNumAtRisk":600,"title":"B-ALL Average Risk-Arm A"},{"deathsNumAffected":8,"deathsNumAtRisk":586,"description":"Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1","id":"EG007","otherNumAffected":204,"otherNumAtRisk":586,"seriousNumAffected":7,"seriousNumAtRisk":586,"title":"B-ALL Average Risk-Arm B"},{"deathsNumAffected":6,"deathsNumAtRisk":586,"description":"Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1","id":"EG008","otherNumAffected":156,"otherNumAtRisk":586,"seriousNumAffected":4,"seriousNumAtRisk":586,"title":"B-ALL Average Risk-Arm C"},{"deathsNumAffected":7,"deathsNumAtRisk":592,"description":"Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1","id":"EG009","otherNumAffected":152,"otherNumAtRisk":592,"seriousNumAffected":3,"seriousNumAtRisk":592,"title":"B-ALL Average Risk-Arm D"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system 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disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9229,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3122,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":224,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":301,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":302,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":600,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":586,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":586,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":592,"numEvents":0}],"term":"Bone marrow hypocellular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system 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