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NCT02017964 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma · Source last updated 2023-01-09

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
1 year
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (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. Ineligible patients are excluded from reporting of adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Eligible Patients (Combination Chemotherapy)

All eligible patients enrolled on the study

2 / 2517 / 252 / 25

Group identifiers: EG000: All Eligible 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. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Other, Progression Of Medulloblastoma

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      4
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hearing impaired
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Meningitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      25
      num Events
      18
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      25
      num Events
      36
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      25
      num Events
      13
    term
    Platelet count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      25
      num Events
      24
    term
    White blood cell decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hypernatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hypokalemia
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (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. Ineligible patients are excluded from reporting of adverse events.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    25
    description
    All eligible patients enrolled on the study
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    25
    serious Num Affected
    2
    serious Num At Risk
    25
    title
    All Eligible Patients (Combination Chemotherapy)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      4
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hearing impaired
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Meningitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      25
      num Events
      18
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      25
      num Events
      36
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      25
      num Events
      13
    term
    Platelet count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      25
      num Events
      24
    term
    White blood cell decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hypernatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hypokalemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Other, Progression Of Medulloblastoma
time Frame
1 year

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Preserved source evidence · Not medical advice