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NCT01190930 · ADVERSE EVENTS

Adverse events

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma · Source last updated 2026-05-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 9 years
Other-event reporting threshold
0%

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.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
B-ALL

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.

72 / 92291776 / 9229125 / 9229
B-LLy

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).

0 / 4830 / 482 / 48
B-ALL Average Risk

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

16 / 31221037 / 312216 / 3122
Standard Risk With Down Syndrome

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).

9 / 224191 / 22411 / 224
B-ALL Low Risk Arm I (LR-M)

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.

0 / 301103 / 3010 / 301
B-ALL Low Risk Arm II (LR-C)

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

0 / 302143 / 3021 / 302
B-ALL Average Risk-Arm A

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

7 / 600180 / 6007 / 600
B-ALL Average Risk-Arm B

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

7 / 586204 / 5868 / 586
B-ALL Average Risk-Arm C

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

4 / 586156 / 5866 / 586
B-ALL Average Risk-Arm D

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

3 / 592152 / 5927 / 592

Group identifiers: EG000: B-ALL · EG001: B-LLy · EG002: B-ALL Average Risk · EG003: Standard Risk With Down Syndrome · EG004: B-ALL Low Risk Arm I (LR-M) · EG005: B-ALL Low Risk Arm II (LR-C) · EG006: B-ALL Average Risk-Arm A · EG007: B-ALL Average Risk-Arm B · EG008: B-ALL Average Risk-Arm C · EG009: B-ALL Average Risk-Arm D

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9229
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      224
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9229
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      600
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      600
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Ventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      224
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Colitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      9229
      num Events
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      3122
      num Events
      21
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      224
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      301
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      302
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      600
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      586
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      586
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      592
      num Events
      3
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3122
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      301
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9229
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      9229
      num Events
      114
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      101
      num At Risk
      3122
      num Events
      112
    4. group Id
      EG003
      num Affected
      114
      num At Risk
      224
      num Events
      185
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      301
      num Events
      15
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      302
      num Events
      16
    7. group Id
      EG006
      num Affected
      28
      num At Risk
      600
      num Events
      34
    8. group Id
      EG007
      num Affected
      35
      num At Risk
      586
      num Events
      40
    9. group Id
      EG008
      num Affected
      23
      num At Risk
      586
      num Events
      26
    10. group Id
      EG009
      num Affected
      27
      num At Risk
      592
      num Events
      32
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      224
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Hemolytic uremic syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      9229
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      224
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Cardiac disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Heart failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      600
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Supraventricular tachycardia
Complete source fields
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.
event Groups
  1. deaths Num Affected
    125
    deaths Num At Risk
    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
    other Num Affected
    1776
    other Num At Risk
    9229
    serious Num Affected
    72
    serious Num At Risk
    9229
    title
    B-ALL
  2. deaths Num Affected
    2
    deaths Num At Risk
    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
    other Num Affected
    30
    other Num At Risk
    48
    serious Num Affected
    0
    serious Num At Risk
    48
    title
    B-LLy
  3. deaths Num Affected
    16
    deaths Num At Risk
    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
    other Num Affected
    1037
    other Num At Risk
    3122
    serious Num Affected
    16
    serious Num At Risk
    3122
    title
    B-ALL Average Risk
  4. deaths Num Affected
    11
    deaths Num At Risk
    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
    other Num Affected
    191
    other Num At Risk
    224
    serious Num Affected
    9
    serious Num At Risk
    224
    title
    Standard Risk With Down Syndrome
  5. deaths Num Affected
    0
    deaths Num At Risk
    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
    other Num Affected
    103
    other Num At Risk
    301
    serious Num Affected
    0
    serious Num At Risk
    301
    title
    B-ALL Low Risk Arm I (LR-M)
  6. deaths Num Affected
    1
    deaths Num At Risk
    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
    other Num Affected
    143
    other Num At Risk
    302
    serious Num Affected
    0
    serious Num At Risk
    302
    title
    B-ALL Low Risk Arm II (LR-C)
  7. deaths Num Affected
    7
    deaths Num At Risk
    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
    other Num Affected
    180
    other Num At Risk
    600
    serious Num Affected
    7
    serious Num At Risk
    600
    title
    B-ALL Average Risk-Arm A
  8. deaths Num Affected
    8
    deaths Num At Risk
    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
    other Num Affected
    204
    other Num At Risk
    586
    serious Num Affected
    7
    serious Num At Risk
    586
    title
    B-ALL Average Risk-Arm B
  9. deaths Num Affected
    6
    deaths Num At Risk
    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
    other Num Affected
    156
    other Num At Risk
    586
    serious Num Affected
    4
    serious Num At Risk
    586
    title
    B-ALL Average Risk-Arm C
  10. deaths Num Affected
    7
    deaths Num At Risk
    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
    other Num Affected
    152
    other Num At Risk
    592
    serious Num Affected
    3
    serious Num At Risk
    592
    title
    B-ALL Average Risk-Arm D
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      9229
      num Events
      26
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      3122
      num Events
      21
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      224
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      301
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      302
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      600
      num Events
      2
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      586
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      586
      num Events
      2
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      592
      num Events
      3
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3122
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      301
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9229
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      9229
      num Events
      114
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      101
      num At Risk
      3122
      num Events
      112
    4. group Id
      EG003
      num Affected
      114
      num At Risk
      224
      num Events
      185
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      301
      num Events
      15
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      302
      num Events
      16
    7. group Id
      EG006
      num Affected
      28
      num At Risk
      600
      num Events
      34
    8. group Id
      EG007
      num Affected
      35
      num At Risk
      586
      num Events
      40
    9. group Id
      EG008
      num Affected
      23
      num At Risk
      586
      num Events
      26
    10. group Id
      EG009
      num Affected
      27
      num At Risk
      592
      num Events
      32
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      224
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Hemolytic uremic syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      9229
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      224
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Cardiac disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Heart failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      600
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Supraventricular tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      586
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9229
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      224
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9229
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      600
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      600
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3122
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Ventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9229
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      224
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9229
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9229
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3122
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      224
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      301
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      302
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      600
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      586
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      586
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      592
      num Events
      0
    term
    Colitis
time Frame
Up to 9 years

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice