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NCT00304070 · OUTCOME

Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor · Source last updated 2024-02-28

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 182 Days After Enrollment

What was measured

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

Groups in this outcome

Stratum 3

Stage III OR IV Disease (chemotherapy)

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

Analysis denominator · Participants

GroupSource count
Stratum 339

Reported measurements

Incidence of Abdominal Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Abdominal Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Acidosis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Activated Partial Thromboplastin Time Prolonged
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Adrenal Insufficiency
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 35Not reportedNot reportedNot reportedNot reported
Incidence of Alanine Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Allergic Reaction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 322Not reportedNot reportedNot reportedNot reported
Incidence of Anorexia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 37Not reportedNot reportedNot reportedNot reported
Incidence of Aspartate Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Blood Bilirubin Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Cardiac Disorders - Other, Specify
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Catheter Related Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 33Not reportedNot reportedNot reportedNot reported
Incidence of Colitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Confusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Dehydration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 33Not reportedNot reportedNot reportedNot reported
Incidence of Depressed Level of Consciousness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Dyspnea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Enterocolitis Infectious
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Esophagitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 316Not reportedNot reportedNot reportedNot reported
Incidence of Fever
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Gastrointestinal Disorders - Other, S
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Generalized Muscle Weakness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of GGT Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Hearing Impaired
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 36Not reportedNot reportedNot reportedNot reported
Incidence of Heart Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Hyperglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 33Not reportedNot reportedNot reportedNot reported
Incidence of Hyperkalemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 33Not reportedNot reportedNot reportedNot reported
Incidence of Hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Hypocalcemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 33Not reportedNot reportedNot reportedNot reported
Incidence of Hypoglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Hypokalemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 39Not reportedNot reportedNot reportedNot reported
Incidence of Hypomagnesemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Hyponatremia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 37Not reportedNot reportedNot reportedNot reported
Incidence of Hypophosphatemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 34Not reportedNot reportedNot reportedNot reported
Incidence of Hypotension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Hypoxia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 33Not reportedNot reportedNot reportedNot reported
Incidence of Infections and Infestations - Other,
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 37Not reportedNot reportedNot reportedNot reported
Incidence of INR Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Left Ventricular Systolic Dysfunction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Lung Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Lymphocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Toxicity Associated with Mitotane
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 34Not reportedNot reportedNot reportedNot reported
Incidence of Mucositis Oral
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 36Not reportedNot reportedNot reportedNot reported
Incidence of Nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 35Not reportedNot reportedNot reportedNot reported
Incidence of Neutrophil Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 320Not reportedNot reportedNot reportedNot reported
Incidence of Obstruction Gastric
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Peripheral Motor Neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Peripheral Sensory Neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Pharyngitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 320Not reportedNot reportedNot reportedNot reported
Incidence of Pneumonitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 33Not reportedNot reportedNot reportedNot reported
Incidence of Premature Menopause
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Rash Maculo-papular
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Sepsis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Skin Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Sore Throat
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Upper Respiratory Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Urinary Tract Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Vascular Access Complication
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 32Not reportedNot reportedNot reportedNot reported
Incidence of Ventricular Arrhythmia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Incidence of Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 35Not reportedNot reportedNot reportedNot reported
Incidence of White Blood Cell Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 316Not reportedNot reportedNot reportedNot reported
Incidence of Wound Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Incidence of Abdominal Infection
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Incidence of Abdominal Pain
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Incidence of Acidosis
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Activated Partial Thromboplastin Time Prolonged
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Incidence of Adrenal Insufficiency
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Incidence of Alanine Aminotransferase Increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Incidence of Allergic Reaction
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Incidence of Anemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Incidence of Anorexia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Incidence of Aspartate Aminotransferase Increased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Incidence of Blood Bilirubin Increased
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Incidence of Cardiac Disorders - Other, Specify
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy
groups
  1. description
    Stage III OR IV Disease (chemotherapy)
    id
    OG000
    title
    Stratum 3
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 182 Days After Enrollment
title
Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice