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NCT00720109 · ADVERSE EVENTS

Adverse events

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2020-04-13

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
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)

See Detailed Description Asparaginase: Given IT Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dasatinib: Given PO Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Hydrocortisone Sodium Succinate: Given IT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV or PO Mercaptopurine: Given PO Methotrexate: Given IT, PO, or IV Methylprednisolone: Given IV Pegaspargase: Given IM Prednisone: Given PO or IV Radiation Therapy: Some patients undergo cranial RT Vincristine Sulfate: Given IV

36 / 6059 / 60Not reported / Not reported
Standard-risk

Based on Minimal Residual Disease, less than 1%.

28 / 4848 / 48Not reported / Not reported
High-risk

Based on Minimal Residual Disease, great than or equal to 1%.

7 / 98 / 9Not reported / Not reported

Group identifiers: EG000: Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) · EG001: Standard-risk · EG002: High-risk

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
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Abdominal distension
  2. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  3. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Agitation
  4. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      60
      num Events
      23
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      48
      num Events
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
      num Events
      6
    term
    Alanine aminotransferase increased
  5. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Alkaline phosphatase increased
  6. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Allergic reaction
  7. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anaphylaxis
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Anemia
  9. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anorexia
  10. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anxiety
  11. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      60
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      48
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      3
    term
    Aspartate aminotransferase increased
  12. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Back pain

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
      7
      num At Risk
      60
      num Events
      7
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      48
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Abdominal pain
  2. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acidosis
  3. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acoustic nerve disorder NOS
  4. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  5. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Adrenal insufficiency
  6. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Agitation
  7. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      60
      num Events
      119
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      48
      num Events
      114
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      5
    term
    Alanine aminotransferase increased
  8. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Alkaline phosphatase increased
  9. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Allergic reaction
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anal mucositis
  11. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      60
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Anaphylaxis
  12. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      60
      num Events
      66
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      48
      num Events
      61
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      4
    term
    Anemia
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
    See Detailed Description Asparaginase: Given IT Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dasatinib: Given PO Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Hydrocortisone Sodium Succinate: Given IT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV or PO Mercaptopurine: Given PO Methotrexate: Given IT, PO, or IV Methylprednisolone: Given IV Pegaspargase: Given IM Prednisone: Given PO or IV Radiation Therapy: Some patients undergo cranial RT Vincristine Sulfate: Given IV
    id
    EG000
    other Num Affected
    59
    other Num At Risk
    60
    serious Num Affected
    36
    serious Num At Risk
    60
    title
    Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
  2. description
    Based on Minimal Residual Disease, less than 1%.
    id
    EG001
    other Num Affected
    48
    other Num At Risk
    48
    serious Num Affected
    28
    serious Num At Risk
    48
    title
    Standard-risk
  3. description
    Based on Minimal Residual Disease, great than or equal to 1%.
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    7
    serious Num At Risk
    9
    title
    High-risk
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      60
      num Events
      7
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      48
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Abdominal pain
  2. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acidosis
  3. organ System
    Nervous system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acoustic nerve disorder NOS
  4. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  5. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Adrenal insufficiency
  6. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Agitation
  7. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      60
      num Events
      119
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      48
      num Events
      114
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      5
    term
    Alanine aminotransferase increased
  8. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Alkaline phosphatase increased
  9. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Allergic reaction
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anal mucositis
  11. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      60
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Anaphylaxis
  12. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      60
      num Events
      66
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      48
      num Events
      61
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      4
    term
    Anemia
serious Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Abdominal distension
  2. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  3. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Agitation
  4. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      60
      num Events
      23
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      48
      num Events
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      9
      num Events
      6
    term
    Alanine aminotransferase increased
  5. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Alkaline phosphatase increased
  6. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Allergic reaction
  7. organ System
    Immune system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anaphylaxis
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      2
    term
    Anemia
  9. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anorexia
  10. organ System
    Psychiatric disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anxiety
  11. organ System
    Investigations
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      60
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      48
      num Events
      8
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      9
      num Events
      3
    term
    Aspartate aminotransferase increased
  12. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Back pain

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

Preserved source evidence · Not medical advice