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NCT00984282 · OUTCOME

Disease Control Rate (DCR) 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

Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. 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. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Analysis population: Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.

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)86.2Not reported80.690.7Not reported
Placebo74.6Not reported68.080.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    3.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.4
    estimate Comment
    Difference of disease control 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
    0.0015
    p Value Comment
    stratified by age group and region
    param Type
    Difference of response rates
    param Value
    11.7
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    3.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.4
    estimate Comment
    Difference of disease control 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
    0.0015
    p Value Comment
    stratified by age group and region
    param Type
    Difference of response rates
    param Value
    11.7
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80.6
        upper Limit
        90.7
        value
        86.2
      2. group Id
        OG001
        lower Limit
        68.0
        upper Limit
        80.5
        value
        74.6
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      201
    units
    Participants
description
Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. 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. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
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
Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.
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
Disease Control Rate (DCR) 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