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NCT00984282 · OUTCOME

Duration of Response (DOR) Based on Central Assessment

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer · Source last updated 2018-09-13

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years

What was measured

Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.

Analysis population: FAS - responders only

Groups in this outcome

Sorafenib (Nexavar, BAY43-9006)

Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle

Placebo

Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle

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

Analysis denominator · Participants

GroupSource count
Sorafenib (Nexavar, BAY43-9006)24
Placebo1

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)309Not reported226505Not reported
PlaceboNANot reportedNANAonly one subject with PR
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        226
        upper Limit
        505
        value
        309
      2. comment
        only one subject with PR
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
dispersion Type
Full Range
groups
  1. description
    Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
    id
    OG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
FAS - responders only
reporting Status
POSTED
time Frame
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
title
Duration of Response (DOR) Based on Central Assessment
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice