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NCT00984282 · OUTCOME

Response Rate 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years

What was measured

Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. 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: PPS

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)196
Placebo201

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)12.24Not reported8.0117.67Not reported
Placebo0.5Not reported0.012.74Not reported

Source statistical analyses

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

  1. ci Lower Limit
    7.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.5
    estimate Comment
    Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    stratified by age group and region
    param Type
    Difference in response rate
    param Value
    11.8
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    7.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.5
    estimate Comment
    Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    stratified by age group and region
    param Type
    Difference in response rate
    param Value
    11.8
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.01
        upper Limit
        17.67
        value
        12.24
      2. group Id
        OG001
        lower Limit
        0.01
        upper Limit
        2.74
        value
        0.5
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      201
    units
    Participants
description
Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. 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
95% Confidence Interval
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
NUMBER
population Description
PPS
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
Response Rate Based on Central Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice