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NCT00334282 · OUTCOME

Participants With Complete Response, Partial Response, or 6 Months of Stable Disease

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline until 6 months post-Baseline or progressive disease

What was measured

This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a \>=20% increase in target lesions. IRC, independent review committee.

Analysis population: ITT Population

Groups in this outcome

Pazopanib 800 mg

Pazopanib 800 mg (tablets) administered orally once a day

Placebo

Matching placebo administered orally 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

Complete Response, IRC assessed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Partial Response, IRC assessed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg87Not reportedNot reportedNot reportedNot reported
Placebo5Not reportedNot reportedNot reportedNot reported
6 Months Stable Disease, IRC assessed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg48Not reportedNot reportedNot reportedNot reported
Placebo17Not reportedNot reportedNot reportedNot reported
Progressive Disease, IRC assessed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg92Not reportedNot reportedNot reportedNot reported
Placebo84Not reportedNot reportedNot reportedNot reported
Unknown
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg62Not reportedNot reportedNot reportedNot reported
Placebo39Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Complete Response, IRC assessed
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        5
    title
    Partial Response, IRC assessed
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        17
    title
    6 Months Stable Disease, IRC assessed
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        84
    title
    Progressive Disease, IRC assessed
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        39
    title
    Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      290
    2. group Id
      OG001
      value
      145
    units
    Participants
description
This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a \>=20% increase in target lesions. IRC, independent review committee.
groups
  1. description
    Pazopanib 800 mg (tablets) administered orally once a day
    id
    OG000
    title
    Pazopanib 800 mg
  2. description
    Matching placebo administered orally once a day
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
ITT Population
reporting Status
POSTED
time Frame
Baseline until 6 months post-Baseline or progressive disease
title
Participants With Complete Response, Partial Response, or 6 Months of Stable Disease
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice