Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00075725 · ADVERSE EVENTS

Adverse events

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia · Source last updated 2021-04-27

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%

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dexamethasone and Capizzi Methotrexate Patients < 10 Years

Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

16 / 218215 / 218Not reported / Not reported
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)

Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

17 / 9087 / 90Not reported / Not reported
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old

Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

42 / 261250 / 261Not reported / Not reported
Dexamethasone, High Dose Methotrexate (IM) < 10 Years

Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

25 / 206203 / 206Not reported / Not reported
Prednisone, Capizzi Methotrexate <10 Years

Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

20 / 214212 / 214Not reported / Not reported
Prednisone, Capezzi Methotrexate >= 10 Years

Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

64 / 598564 / 598Not reported / Not reported
Prednisone and High Dose Methotrexate < 10 Yrs Old

Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

16 / 213204 / 213Not reported / Not reported
Prednisone and High Dose Methotrexate >=10 Years

Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

67 / 601576 / 601Not reported / Not reported
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years

Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

27 / 262256 / 262Not reported / Not reported
Prednisone, Capezzi Methotrexate (Down's Syndrome)

Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

3 / 3030 / 30Not reported / Not reported
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)

Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

3 / 99 / 9Not reported / Not reported
Prednisone and High Dose Methotrexate (Non Randomly Assigned)

Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

1 / 2320 / 23Not reported / Not reported

Group identifiers: EG000: Dexamethasone and Capizzi Methotrexate Patients < 10 Years · EG001: Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) · EG002: Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old · EG003: Dexamethasone, High Dose Methotrexate (IM) < 10 Years · EG004: Prednisone, Capizzi Methotrexate <10 Years · EG005: Prednisone, Capezzi Methotrexate >= 10 Years · EG006: Prednisone and High Dose Methotrexate < 10 Yrs Old · EG007: Prednisone and High Dose Methotrexate >=10 Years · EG008: Dexamethasone, High Dose Methotrexate (IM) >= 10 Years · EG009: Prednisone, Capezzi Methotrexate (Down's Syndrome) · EG010: Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) · EG011: Prednisone and High Dose Methotrexate (Non Randomly Assigned)

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
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal distension
  2. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal pain
  3. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal soft tissue necrosis
  4. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      598
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      601
      num Events
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      262
      num Events
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acidosis
  5. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      601
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  6. organ System
    Renal and urinary disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      261
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      598
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      601
      num Events
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acute kidney injury
  7. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adrenal insufficiency
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      598
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      601
      num Events
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adult respiratory distress syndrome
  9. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      218
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      261
      num Events
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      206
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      214
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      213
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      601
      num Events
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alanine aminotransferase increased
  10. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alkalosis
  11. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      218
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      598
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Allergic reaction
  12. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Amnesia

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
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      90
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      213
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal distension
  2. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      261
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      214
      num Events
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      213
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal infection
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      218
      num Events
      13
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      90
      num Events
      15
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      261
      num Events
      45
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      206
      num Events
      20
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      214
      num Events
      13
    6. group Id
      EG005
      num Affected
      52
      num At Risk
      598
      num Events
      68
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      213
      num Events
      9
    8. group Id
      EG007
      num Affected
      35
      num At Risk
      601
      num Events
      46
    9. group Id
      EG008
      num Affected
      16
      num At Risk
      262
      num Events
      23
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Abdominal pain
  4. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Accessory nerve disorder
  5. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      218
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      90
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      261
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      214
      num Events
      3
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      598
      num Events
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      14
      num At Risk
      601
      num Events
      14
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      262
      num Events
      7
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      30
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acidosis
  6. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      218
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      90
      num Events
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      261
      num Events
      18
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      206
      num Events
      8
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      214
      num Events
      5
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      598
      num Events
      19
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      213
      num Events
      6
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      601
      num Events
      22
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      262
      num Events
      13
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      30
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  7. organ System
    Renal and urinary disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      90
      num Events
      2
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      261
      num Events
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      214
      num Events
      2
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      598
      num Events
      17
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      213
      num Events
      1
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      601
      num Events
      13
    9. group Id
      EG008
      num Affected
      12
      num At Risk
      262
      num Events
      15
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
      num Events
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acute kidney injury
  8. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      90
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      214
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      598
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adrenal insufficiency
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      261
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      601
      num Events
      5
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      262
      num Events
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adult respiratory distress syndrome
  10. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      90
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      206
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      214
      num Events
      2
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      8
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      213
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      601
      num Events
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Agitation
  11. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      218
      num Events
      272
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      90
      num Events
      88
    3. group Id
      EG002
      num Affected
      122
      num At Risk
      261
      num Events
      305
    4. group Id
      EG003
      num Affected
      94
      num At Risk
      206
      num Events
      294
    5. group Id
      EG004
      num Affected
      92
      num At Risk
      214
      num Events
      263
    6. group Id
      EG005
      num Affected
      274
      num At Risk
      598
      num Events
      780
    7. group Id
      EG006
      num Affected
      101
      num At Risk
      213
      num Events
      352
    8. group Id
      EG007
      num Affected
      275
      num At Risk
      601
      num Events
      749
    9. group Id
      EG008
      num Affected
      125
      num At Risk
      262
      num Events
      303
    10. group Id
      EG009
      num Affected
      12
      num At Risk
      30
      num Events
      27
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
      num Events
      3
    12. group Id
      EG011
      num Affected
      10
      num At Risk
      23
      num Events
      18
    term
    Alanine aminotransferase increased
  12. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alcohol intolerance
Complete source fields
description
SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
event Groups
  1. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    EG000
    other Num Affected
    215
    other Num At Risk
    218
    serious Num Affected
    16
    serious Num At Risk
    218
    title
    Dexamethasone and Capizzi Methotrexate Patients < 10 Years
  2. description
    Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    EG001
    other Num Affected
    87
    other Num At Risk
    90
    serious Num Affected
    17
    serious Num At Risk
    90
    title
    Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
  3. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    EG002
    other Num Affected
    250
    other Num At Risk
    261
    serious Num Affected
    42
    serious Num At Risk
    261
    title
    Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
  4. description
    Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    EG003
    other Num Affected
    203
    other Num At Risk
    206
    serious Num Affected
    25
    serious Num At Risk
    206
    title
    Dexamethasone, High Dose Methotrexate (IM) < 10 Years
  5. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    EG004
    other Num Affected
    212
    other Num At Risk
    214
    serious Num Affected
    20
    serious Num At Risk
    214
    title
    Prednisone, Capizzi Methotrexate <10 Years
  6. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    EG005
    other Num Affected
    564
    other Num At Risk
    598
    serious Num Affected
    64
    serious Num At Risk
    598
    title
    Prednisone, Capezzi Methotrexate >= 10 Years
  7. description
    Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    EG006
    other Num Affected
    204
    other Num At Risk
    213
    serious Num Affected
    16
    serious Num At Risk
    213
    title
    Prednisone and High Dose Methotrexate < 10 Yrs Old
  8. description
    Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    EG007
    other Num Affected
    576
    other Num At Risk
    601
    serious Num Affected
    67
    serious Num At Risk
    601
    title
    Prednisone and High Dose Methotrexate >=10 Years
  9. description
    Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    EG008
    other Num Affected
    256
    other Num At Risk
    262
    serious Num Affected
    27
    serious Num At Risk
    262
    title
    Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
  10. description
    Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    EG009
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    3
    serious Num At Risk
    30
    title
    Prednisone, Capezzi Methotrexate (Down's Syndrome)
  11. description
    Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
    id
    EG010
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
  12. description
    Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
    id
    EG011
    other Num Affected
    20
    other Num At Risk
    23
    serious Num Affected
    1
    serious Num At Risk
    23
    title
    Prednisone and High Dose Methotrexate (Non Randomly Assigned)
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      90
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      213
      num Events
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal distension
  2. organ System
    Infections and infestations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      261
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      214
      num Events
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      213
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal infection
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      218
      num Events
      13
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      90
      num Events
      15
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      261
      num Events
      45
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      206
      num Events
      20
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      214
      num Events
      13
    6. group Id
      EG005
      num Affected
      52
      num At Risk
      598
      num Events
      68
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      213
      num Events
      9
    8. group Id
      EG007
      num Affected
      35
      num At Risk
      601
      num Events
      46
    9. group Id
      EG008
      num Affected
      16
      num At Risk
      262
      num Events
      23
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Abdominal pain
  4. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Accessory nerve disorder
  5. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      218
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      90
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      261
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      214
      num Events
      3
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      598
      num Events
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      14
      num At Risk
      601
      num Events
      14
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      262
      num Events
      7
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      30
      num Events
      2
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acidosis
  6. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      218
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      90
      num Events
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      261
      num Events
      18
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      206
      num Events
      8
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      214
      num Events
      5
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      598
      num Events
      19
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      213
      num Events
      6
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      601
      num Events
      22
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      262
      num Events
      13
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      30
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  7. organ System
    Renal and urinary disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      90
      num Events
      2
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      261
      num Events
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      214
      num Events
      2
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      598
      num Events
      17
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      213
      num Events
      1
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      601
      num Events
      13
    9. group Id
      EG008
      num Affected
      12
      num At Risk
      262
      num Events
      15
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
      num Events
      2
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acute kidney injury
  8. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      90
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      214
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      598
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adrenal insufficiency
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      261
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      601
      num Events
      5
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      262
      num Events
      8
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adult respiratory distress syndrome
  10. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      218
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      90
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      206
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      214
      num Events
      2
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      8
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      213
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      601
      num Events
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Agitation
  11. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      218
      num Events
      272
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      90
      num Events
      88
    3. group Id
      EG002
      num Affected
      122
      num At Risk
      261
      num Events
      305
    4. group Id
      EG003
      num Affected
      94
      num At Risk
      206
      num Events
      294
    5. group Id
      EG004
      num Affected
      92
      num At Risk
      214
      num Events
      263
    6. group Id
      EG005
      num Affected
      274
      num At Risk
      598
      num Events
      780
    7. group Id
      EG006
      num Affected
      101
      num At Risk
      213
      num Events
      352
    8. group Id
      EG007
      num Affected
      275
      num At Risk
      601
      num Events
      749
    9. group Id
      EG008
      num Affected
      125
      num At Risk
      262
      num Events
      303
    10. group Id
      EG009
      num Affected
      12
      num At Risk
      30
      num Events
      27
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
      num Events
      3
    12. group Id
      EG011
      num Affected
      10
      num At Risk
      23
      num Events
      18
    term
    Alanine aminotransferase increased
  12. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alcohol intolerance
serious Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal distension
  2. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal pain
  3. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal soft tissue necrosis
  4. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      598
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      601
      num Events
      3
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      262
      num Events
      3
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acidosis
  5. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      601
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  6. organ System
    Renal and urinary disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      261
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      598
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      601
      num Events
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Acute kidney injury
  7. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adrenal insufficiency
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      598
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      601
      num Events
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Adult respiratory distress syndrome
  9. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      218
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      261
      num Events
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      206
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      214
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      598
      num Events
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      213
      num Events
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      601
      num Events
      3
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      262
      num Events
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      30
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alanine aminotransferase increased
  10. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      206
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alkalosis
  11. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      218
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      261
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      598
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      601
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Allergic reaction
  12. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      218
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      90
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      261
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      206
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      214
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      598
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      213
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      601
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      262
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      30
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Amnesia

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

Preserved source evidence · Not medical advice