Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00653068 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System · Source last updated 2024-04-23

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%

There were no patients enrolled in Stratum 2 or 4.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stratum I

Infants (\<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT

7 / 5743 / 57Not reported / Not reported
Stratum III

Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.

0 / 118 / 11Not reported / Not reported

Group identifiers: EG000: Stratum I · EG001: Stratum III

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
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Disseminated intravascular coagulation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Left ventricular systolic dysfunction
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Multi-organ failure
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Enterocolitis infectious
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sepsis
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Upper respiratory infection
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymphocyte count decreased
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutrophil count decreased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    White blood cell decreased
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Acidosis
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypoalbuminemia
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypokalemia

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
      6
      num At Risk
      57
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Febrile neutropenia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus tachycardia
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hearing impaired
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Diarrhea
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Gastrointestinal disorders - Other, specify
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Mucositis oral
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Vomiting
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Death NOS
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Catheter related infection
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Infections and infestations - Other, specify
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Lung infection
Complete source fields
description
There were no patients enrolled in Stratum 2 or 4.
event Groups
  1. description
    Infants (\<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT
    id
    EG000
    other Num Affected
    43
    other Num At Risk
    57
    serious Num Affected
    7
    serious Num At Risk
    57
    title
    Stratum I
  2. description
    Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    11
    serious Num Affected
    0
    serious Num At Risk
    11
    title
    Stratum III
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Febrile neutropenia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus tachycardia
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hearing impaired
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Diarrhea
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Gastrointestinal disorders - Other, specify
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Mucositis oral
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Vomiting
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Death NOS
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Catheter related infection
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Infections and infestations - Other, specify
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Lung infection
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Disseminated intravascular coagulation
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Left ventricular systolic dysfunction
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Multi-organ failure
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Enterocolitis infectious
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sepsis
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Upper respiratory infection
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymphocyte count decreased
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutrophil count decreased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    White blood cell decreased
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Acidosis
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypoalbuminemia
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypokalemia

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

Preserved source evidence · Not medical advice