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NCT00335556 · OUTCOME

Toxicity Rate

Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors · Source last updated 2017-07-21

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

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Up to 4 years

What was measured

Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.

Analysis population: Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.

Groups in this outcome

Combined UH-2, UH-1, Window/UH-1

Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring

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

Analysis denominator · Participants

GroupSource count
Combined UH-2, UH-1, Window/UH-161

Reported measurements

Cardiac toxicities
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combined UH-2, UH-1, Window/UH-14.9Not reported010.3Not reported
Treatment-related deaths
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combined UH-2, UH-1, Window/UH-14.9Not reported010.3Not reported
Sinusoidal Obstruction Syndrome
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combined UH-2, UH-1, Window/UH-10Not reported00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        10.3
        value
        4.9
    title
    Cardiac toxicities
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        10.3
        value
        4.9
    title
    Treatment-related deaths
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    Sinusoidal Obstruction Syndrome
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    units
    Participants
description
Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.
dispersion Type
95% Confidence Interval
groups
  1. description
    Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring
    id
    OG000
    title
    Combined UH-2, UH-1, Window/UH-1
param Type
NUMBER
population Description
Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.
reporting Status
POSTED
time Frame
Up to 4 years
title
Toxicity Rate
type
PRIMARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice