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NCT00334282 · OUTCOME

Progression-free Survival

Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma · Source last updated 2016-02-05

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Randomization until progression (up to 2 years)

What was measured

Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.

Analysis population: Intent-to-Treat (ITT) Population: all randomized participants

Groups in this outcome

Pazopanib 800 mg

Pazopanib 800 mg (tablets) administered orally once a day

Placebo

Matching Placebo administered once a day

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

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg290
Placebo145

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg9.2Not reported7.412.9Not reported
Placebo4.2Not reported2.85.6Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.34
    ci Pct Value
    95
    ci Upper Limit
    0.62
    estimate Comment
    The estimated value is the hazard ratio comparing pazopanib to placebo.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .0000001
    p Value Comment
    stratified log-rank test
    param Type
    Hazard Ratio (HR)
    param Value
    0.46
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.34
    ci Pct Value
    95
    ci Upper Limit
    0.62
    estimate Comment
    The estimated value is the hazard ratio comparing pazopanib to placebo.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .0000001
    p Value Comment
    stratified log-rank test
    param Type
    Hazard Ratio (HR)
    param Value
    0.46
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.4
        upper Limit
        12.9
        value
        9.2
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        5.6
        value
        4.2
denoms
  1. counts
    1. group Id
      OG000
      value
      290
    2. group Id
      OG001
      value
      145
    units
    Participants
description
Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pazopanib 800 mg (tablets) administered orally once a day
    id
    OG000
    title
    Pazopanib 800 mg
  2. description
    Matching Placebo administered once a day
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Intent-to-Treat (ITT) Population: all randomized participants
reporting Status
POSTED
time Frame
Randomization until progression (up to 2 years)
title
Progression-free Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice