Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00096135 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes · Source last updated 2017-03-21

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. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CNS Patients - Treatment (Combination Chemotherapy)

All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.

7 / 124119 / 124Not reported / Not reported
Testicular Relapse Patients (Combination Chemotherapy)

All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.

1 / 4241 / 42Not reported / Not reported

Group identifiers: EG000: CNS Patients - Treatment (Combination Chemotherapy) · EG001: Testicular Relapse Patients (Combination Chemotherapy)

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Disseminated intravascular coagulation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Cardiac disorders - Other
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Death NOS
  4. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hepatic failure
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      124
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Infections and infestations - Other
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Lung infection
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Alanine aminotransferase increased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Aspartate aminotransferase increased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Blood bilirubin increased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Fibrinogen decreased
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    GGT increased

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      124
      num Events
      65
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      42
      num Events
      15
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Blood and lymphatic system disorders - Other
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      124
      num Events
      86
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      42
      num Events
      30
    term
    Febrile neutropenia
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      124
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Sinus tachycardia
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      124
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Middle ear inflammation
  7. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Extraocular muscle paresis
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Eye disorders - Other
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Photophobia
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      124
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Abdominal pain
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anal mucositis
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anal pain
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. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
event Groups
  1. description
    All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
    id
    EG000
    other Num Affected
    119
    other Num At Risk
    124
    serious Num Affected
    7
    serious Num At Risk
    124
    title
    CNS Patients - Treatment (Combination Chemotherapy)
  2. description
    All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
    id
    EG001
    other Num Affected
    41
    other Num At Risk
    42
    serious Num Affected
    1
    serious Num At Risk
    42
    title
    Testicular Relapse Patients (Combination Chemotherapy)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      124
      num Events
      65
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      42
      num Events
      15
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Blood and lymphatic system disorders - Other
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      124
      num Events
      86
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      42
      num Events
      30
    term
    Febrile neutropenia
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      124
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Sinus tachycardia
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      124
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Middle ear inflammation
  7. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Extraocular muscle paresis
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Eye disorders - Other
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Photophobia
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      124
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Abdominal pain
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      124
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anal mucositis
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anal pain
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Disseminated intravascular coagulation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Cardiac disorders - Other
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Death NOS
  4. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Hepatic failure
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      124
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Infections and infestations - Other
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Lung infection
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Alanine aminotransferase increased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Aspartate aminotransferase increased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Blood bilirubin increased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Fibrinogen decreased
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      124
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    GGT increased

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

Preserved source evidence · Not medical advice