Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00027846 · ADVERSE EVENTS

Adverse events

Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma · Source last updated 2019-08-07

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
5%

All eligible patients were considered in the evaluation of adverse events. 281 eligible patients were in the group 2 and 64 eligible patients were in the group 3. GTR1 Differentiated Histology Supratentorial (Group 1) is an observation arm. Adverse events were not collected for the " GTR1 Differential Histology Supratentorial(Group 1)" observation arm..

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Radiation (Group 2)

Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks

38 / 28152 / 281Not reported / Not reported
Sub-Total Resection Any Histology or Location (STR) (Group 3)

Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient

55 / 6427 / 64Not reported / Not reported

Group identifiers: EG000: Radiation (Group 2) · EG001: Sub-Total Resection Any Histology or Location (STR) (Group 3)

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
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    term
    Inner ear/hearing
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      64
      num Events
      31
    term
    Hemoglobin (Hgb)
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    term
    Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      281
      num Events
      4
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      64
      num Events
      47
    term
    Leukocytes (total WBC)
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      281
      num Events
      8
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      64
      num Events
      18
    term
    Lymphopenia
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      281
      num Events
      6
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      64
      num Events
      49
    term
    Neutrophils/granulocytes (ANC/AGC)
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      64
      num Events
      28
    term
    Platelets
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      64
      num Events
      11
    term
    Transfusion: Platelets
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      281
      num Events
      1
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      64
      num Events
      17
    term
    Transfusion: pRBCs
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    term
    Hypertension
  11. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    term
    Thrombosis/embolism
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      281
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    term
    Cardiovascular/General - Other (Specify)

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
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
      num Events
      5
    term
    Hemoglobin (Hgb)
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      281
      num Events
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      64
      num Events
      9
    term
    Leukocytes (total WBC)
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      64
      num Events
      7
    term
    Platelets
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      64
      num Events
      9
    term
    Fatigue (lethargy, malaise, asthenia)
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
      num Events
      6
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L)
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      4
    term
    Weight loss
  7. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      281
      num Events
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    term
    Alopecia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      5
    term
    Anorexia
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      64
      num Events
      6
    term
    Constipation
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
      num Events
      6
    term
    Nausea
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      281
      num Events
      19
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      64
      num Events
      9
    term
    Vomiting
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      64
      num Events
      6
    term
    SGOT (AST)
Complete source fields
description
All eligible patients were considered in the evaluation of adverse events. 281 eligible patients were in the group 2 and 64 eligible patients were in the group 3. GTR1 Differentiated Histology Supratentorial (Group 1) is an observation arm. Adverse events were not collected for the " GTR1 Differential Histology Supratentorial(Group 1)" observation arm..
event Groups
  1. description
    Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks
    id
    EG000
    other Num Affected
    52
    other Num At Risk
    281
    serious Num Affected
    38
    serious Num At Risk
    281
    title
    Radiation (Group 2)
  2. description
    Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    64
    serious Num Affected
    55
    serious Num At Risk
    64
    title
    Sub-Total Resection Any Histology or Location (STR) (Group 3)
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
      num Events
      5
    term
    Hemoglobin (Hgb)
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      281
      num Events
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      64
      num Events
      9
    term
    Leukocytes (total WBC)
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      64
      num Events
      7
    term
    Platelets
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      64
      num Events
      9
    term
    Fatigue (lethargy, malaise, asthenia)
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
      num Events
      6
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L)
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      4
    term
    Weight loss
  7. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      281
      num Events
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    term
    Alopecia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      5
    term
    Anorexia
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      64
      num Events
      6
    term
    Constipation
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      64
      num Events
      6
    term
    Nausea
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      281
      num Events
      19
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      64
      num Events
      9
    term
    Vomiting
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      64
      num Events
      6
    term
    SGOT (AST)
serious Events
  1. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    term
    Inner ear/hearing
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      64
      num Events
      31
    term
    Hemoglobin (Hgb)
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    term
    Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      281
      num Events
      4
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      64
      num Events
      47
    term
    Leukocytes (total WBC)
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      281
      num Events
      8
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      64
      num Events
      18
    term
    Lymphopenia
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      281
      num Events
      6
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      64
      num Events
      49
    term
    Neutrophils/granulocytes (ANC/AGC)
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      64
      num Events
      28
    term
    Platelets
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      64
      num Events
      11
    term
    Transfusion: Platelets
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      281
      num Events
      1
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      64
      num Events
      17
    term
    Transfusion: pRBCs
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    term
    Hypertension
  11. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      281
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    term
    Thrombosis/embolism
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      281
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    term
    Cardiovascular/General - Other (Specify)

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

Preserved source evidence · Not medical advice