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NCT00753688 · OUTCOME

Duration of Response Assessed by the Independent Radiologist and the Investigator

Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy · Source last updated 2013-08-22

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)

What was measured

Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.

Analysis population: ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.

Groups in this outcome

Placebo

Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

Pazopanib

Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

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

Analysis denominator · Participants

GroupSource count
Placebo0
Pazopanib23

Reported measurements

Independent radiologist assessed, n=0, 11
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pazopanib38.9Not reported16.740.0Not reported
Investigator assessed, n=0, 23
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pazopanib32.1Not reported22.644.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        16.7
        upper Limit
        40.0
        value
        38.9
    title
    Independent radiologist assessed, n=0, 11
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        22.6
        upper Limit
        44.0
        value
        32.1
    title
    Investigator assessed, n=0, 23
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
    id
    OG000
    title
    Placebo
  2. description
    Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
    id
    OG001
    title
    Pazopanib
param Type
MEDIAN
population Description
ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.
reporting Status
POSTED
time Frame
From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)
title
Duration of Response Assessed by the Independent Radiologist and the Investigator
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice