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NCT00053352 · OUTCOME

Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors · Source last updated 2021-07-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
patients
Interval / dispersion
Not reported
Time frame
Up to 126 days after the start of chemotherapy

What was measured

The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy

Analysis population: 182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint

Groups in this outcome

Arm I

Experimental

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I182

Reported measurements

Abdominal pain
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I3Not reportedNot reportedNot reportedNot reported
Acute kidney injury
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Lymphocyte count decrease
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I2Not reportedNot reportedNot reportedNot reported
Iincrease in alanine aminotransferase
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Neutrophil count decrease
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I58Not reportedNot reportedNot reportedNot reported
Anemia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I10Not reportedNot reportedNot reportedNot reported
Increase in aspartate aminotransferase
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Catheter related infection
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Constipation
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Dehydration
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Encephalopathy
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I9Not reportedNot reportedNot reportedNot reported
Fever
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I3Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Hypocalcemia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I2Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I6Not reportedNot reportedNot reportedNot reported
Small intestine obstruction
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Nausea
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I5Not reportedNot reportedNot reportedNot reported
Non-cardiac chest pain
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Other gastrointestinal disorders
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Other infection
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I10Not reportedNot reportedNot reportedNot reported
Platelet count decrease
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I7Not reportedNot reportedNot reportedNot reported
Syncope
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Vomiting
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I4Not reportedNot reportedNot reportedNot reported
White blood cell decrease
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I17Not reportedNot reportedNot reportedNot reported
Wound infection
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Abdominal pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Acute kidney injury
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Lymphocyte count decrease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Iincrease in alanine aminotransferase
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        58
    title
    Neutrophil count decrease
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Anemia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Increase in aspartate aminotransferase
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Catheter related infection
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Constipation
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dehydration
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Encephalopathy
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Febrile neutropenia
denoms
  1. counts
    1. group Id
      OG000
      value
      182
    units
    Participants
description
The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy
groups
  1. description
    Experimental
    id
    OG000
    title
    Arm I
param Type
NUMBER
population Description
182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint
reporting Status
POSTED
time Frame
Up to 126 days after the start of chemotherapy
title
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
type
SECONDARY
unit Of Measure
patients

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

Preserved source evidence · Not medical advice