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NCT00387764 · OUTCOME

Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)

Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer · Source last updated 2014-01-14

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
From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)

What was measured

The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.

Analysis population: ATS Population. An analysis was performed on 71 participants.

Groups in this outcome

Pazopanib 800 mg

Participants received pazopanib 800 milligrams (mg) once daily.

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 mg71

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg35Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.
groups
  1. description
    Participants received pazopanib 800 milligrams (mg) once daily.
    id
    OG000
    title
    Pazopanib 800 mg
param Type
NUMBER
population Description
ATS Population. An analysis was performed on 71 participants.
reporting Status
POSTED
time Frame
From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)
title
Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice