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NCT00103285 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2021-06-14

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
Not reported
Other-event reporting threshold
0%

Only eligible patients are included in the toxicity analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 0 Induction Therapy

All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV

29 / 1306790 / 1306Not reported / Not reported
Group 1-SR-low ALL, Arm I-combination Chemotherapy

Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV

14 / 931901 / 931Not reported / Not reported
Group 1-SR-low ALL, Arm II-combination Chemotherapy

Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV

7 / 931909 / 931Not reported / Not reported
Group 2-SR-avg ALL, Arm I-combination Chemotherapy

Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV

4 / 501487 / 501Not reported / Not reported
Group 2-SR-avg ALL, Arm II-combination Chemotherapy

Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV

3 / 509500 / 509Not reported / Not reported
Group 2-SR-avg ALL, Arm III-combination Chemotherapy

Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV

0 / 246237 / 246Not reported / Not reported
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy

Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV

1 / 247234 / 247Not reported / Not reported
Group 3-SR-high ALL, Combination Chemotherapy

Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine \& vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, methotrexate and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, methotrexate. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT 3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine

12 / 638629 / 638Not reported / Not reported

Group identifiers: EG000: Group 0 Induction Therapy · EG001: Group 1-SR-low ALL, Arm I-combination Chemotherapy · EG002: Group 1-SR-low ALL, Arm II-combination Chemotherapy · EG003: Group 2-SR-avg ALL, Arm I-combination Chemotherapy · EG004: Group 2-SR-avg ALL, Arm II-combination Chemotherapy · EG005: Group 2-SR-avg ALL, Arm III-combination Chemotherapy · EG006: Group 2-SR-avg ALL, Arm IV-combination Chemotherapy · EG007: Group 3-SR-high ALL, Combination Chemotherapy

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1306
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Febrile neutropenia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Hemolysis
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Cardiac arrest
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Myocardial infarction
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Abdominal pain
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Ascites
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Cecal hemorrhage
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Colitis
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Colonic perforation
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      931
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Diarrhea

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      1306
      num Events
      88
    2. group Id
      EG001
      num Affected
      258
      num At Risk
      931
      num Events
      438
    3. group Id
      EG002
      num Affected
      232
      num At Risk
      931
      num Events
      356
    4. group Id
      EG003
      num Affected
      119
      num At Risk
      501
      num Events
      183
    5. group Id
      EG004
      num Affected
      127
      num At Risk
      509
      num Events
      213
    6. group Id
      EG005
      num Affected
      55
      num At Risk
      246
      num Events
      113
    7. group Id
      EG006
      num Affected
      90
      num At Risk
      247
      num Events
      150
    8. group Id
      EG007
      num Affected
      213
      num At Risk
      638
      num Events
      466
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      931
      num Events
      16
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      931
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      501
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      509
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      246
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      247
      num Events
      1
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      638
      num Events
      9
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      246
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Bone marrow hypocellular
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      931
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      931
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      638
      num Events
      2
    term
    Disseminated intravascular coagulation
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      1306
      num Events
      131
    2. group Id
      EG001
      num Affected
      531
      num At Risk
      931
      num Events
      1045
    3. group Id
      EG002
      num Affected
      555
      num At Risk
      931
      num Events
      1045
    4. group Id
      EG003
      num Affected
      272
      num At Risk
      501
      num Events
      513
    5. group Id
      EG004
      num Affected
      330
      num At Risk
      509
      num Events
      733
    6. group Id
      EG005
      num Affected
      144
      num At Risk
      246
      num Events
      259
    7. group Id
      EG006
      num Affected
      150
      num At Risk
      247
      num Events
      316
    8. group Id
      EG007
      num Affected
      475
      num At Risk
      638
      num Events
      1260
    term
    Febrile neutropenia
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      931
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      931
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      501
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Hemolysis
  7. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Hemolytic uremic syndrome
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      501
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Leukocytosis
  9. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      509
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Spleen disorder
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Cardiac arrest
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1306
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      931
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      246
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      638
      num Events
      2
    term
    Cardiac disorders - Other, specify
  12. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Conduction disorder
Complete source fields
description
Only eligible patients are included in the toxicity analysis.
event Groups
  1. description
    All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV
    id
    EG000
    other Num Affected
    790
    other Num At Risk
    1306
    serious Num Affected
    29
    serious Num At Risk
    1306
    title
    Group 0 Induction Therapy
  2. description
    Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
    id
    EG001
    other Num Affected
    901
    other Num At Risk
    931
    serious Num Affected
    14
    serious Num At Risk
    931
    title
    Group 1-SR-low ALL, Arm I-combination Chemotherapy
  3. description
    Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
    id
    EG002
    other Num Affected
    909
    other Num At Risk
    931
    serious Num Affected
    7
    serious Num At Risk
    931
    title
    Group 1-SR-low ALL, Arm II-combination Chemotherapy
  4. description
    Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
    id
    EG003
    other Num Affected
    487
    other Num At Risk
    501
    serious Num Affected
    4
    serious Num At Risk
    501
    title
    Group 2-SR-avg ALL, Arm I-combination Chemotherapy
  5. description
    Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
    id
    EG004
    other Num Affected
    500
    other Num At Risk
    509
    serious Num Affected
    3
    serious Num At Risk
    509
    title
    Group 2-SR-avg ALL, Arm II-combination Chemotherapy
  6. description
    Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
    id
    EG005
    other Num Affected
    237
    other Num At Risk
    246
    serious Num Affected
    0
    serious Num At Risk
    246
    title
    Group 2-SR-avg ALL, Arm III-combination Chemotherapy
  7. description
    Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
    id
    EG006
    other Num Affected
    234
    other Num At Risk
    247
    serious Num Affected
    1
    serious Num At Risk
    247
    title
    Group 2-SR-avg ALL, Arm IV-combination Chemotherapy
  8. description
    Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine \& vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, methotrexate and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, methotrexate. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT 3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine
    id
    EG007
    other Num Affected
    629
    other Num At Risk
    638
    serious Num Affected
    12
    serious Num At Risk
    638
    title
    Group 3-SR-high ALL, Combination Chemotherapy
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      1306
      num Events
      88
    2. group Id
      EG001
      num Affected
      258
      num At Risk
      931
      num Events
      438
    3. group Id
      EG002
      num Affected
      232
      num At Risk
      931
      num Events
      356
    4. group Id
      EG003
      num Affected
      119
      num At Risk
      501
      num Events
      183
    5. group Id
      EG004
      num Affected
      127
      num At Risk
      509
      num Events
      213
    6. group Id
      EG005
      num Affected
      55
      num At Risk
      246
      num Events
      113
    7. group Id
      EG006
      num Affected
      90
      num At Risk
      247
      num Events
      150
    8. group Id
      EG007
      num Affected
      213
      num At Risk
      638
      num Events
      466
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      931
      num Events
      16
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      931
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      501
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      509
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      246
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      247
      num Events
      1
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      638
      num Events
      9
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      246
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Bone marrow hypocellular
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      931
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      931
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      638
      num Events
      2
    term
    Disseminated intravascular coagulation
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      1306
      num Events
      131
    2. group Id
      EG001
      num Affected
      531
      num At Risk
      931
      num Events
      1045
    3. group Id
      EG002
      num Affected
      555
      num At Risk
      931
      num Events
      1045
    4. group Id
      EG003
      num Affected
      272
      num At Risk
      501
      num Events
      513
    5. group Id
      EG004
      num Affected
      330
      num At Risk
      509
      num Events
      733
    6. group Id
      EG005
      num Affected
      144
      num At Risk
      246
      num Events
      259
    7. group Id
      EG006
      num Affected
      150
      num At Risk
      247
      num Events
      316
    8. group Id
      EG007
      num Affected
      475
      num At Risk
      638
      num Events
      1260
    term
    Febrile neutropenia
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      931
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      931
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      501
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Hemolysis
  7. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Hemolytic uremic syndrome
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      501
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Leukocytosis
  9. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      509
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Spleen disorder
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Cardiac arrest
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1306
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      931
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      246
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      638
      num Events
      2
    term
    Cardiac disorders - Other, specify
  12. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Conduction disorder
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1306
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      931
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Febrile neutropenia
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Hemolysis
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1306
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Cardiac arrest
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Myocardial infarction
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      931
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Abdominal pain
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Ascites
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Cecal hemorrhage
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Colitis
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1306
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      931
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      638
      num Events
      1
    term
    Colonic perforation
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1306
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      931
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      931
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      501
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      509
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      246
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      247
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      638
      num Events
      0
    term
    Diarrhea

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

Preserved source evidence · Not medical advice