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NCT00984282 · OUTCOME

Maximum Percent Reduction in Target Lesion Size 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
Not reported
Time frame
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years

What was measured

The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.

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

Reduction ≥ 30%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)17.3Not reportedNot reportedNot reportedNot reported
Placebo1.0Not reportedNot reportedNot reportedNot reported
Reduction ≥ 20% but < 30%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)15.3Not reportedNot reportedNot reportedNot reported
Placebo1.5Not reportedNot reportedNot reportedNot reported
Reduction ≥ 10% but < 20%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)22.4Not reportedNot reportedNot reportedNot reported
Placebo3.5Not reportedNot reportedNot reportedNot reported
Reduction > 0% but < 10%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)22.4Not reportedNot reportedNot reportedNot reported
Placebo21.9Not reportedNot reportedNot reportedNot reported
Growth ≥ 0%
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)12.8Not reportedNot reportedNot reportedNot reported
Placebo62.7Not reportedNot reportedNot reportedNot reported
Not assessed
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)9.7Not reportedNot reportedNot reportedNot reported
Placebo9.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17.3
      2. group Id
        OG001
        value
        1.0
    title
    Reduction ≥ 30%
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15.3
      2. group Id
        OG001
        value
        1.5
    title
    Reduction ≥ 20% but < 30%
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22.4
      2. group Id
        OG001
        value
        3.5
    title
    Reduction ≥ 10% but < 20%
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        22.4
      2. group Id
        OG001
        value
        21.9
    title
    Reduction > 0% but < 10%
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        12.8
      2. group Id
        OG001
        value
        62.7
    title
    Growth ≥ 0%
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9.7
      2. group Id
        OG001
        value
        9.5
    title
    Not assessed
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      201
    units
    Participants
description
The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.
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
Maximum Percent Reduction in Target Lesion Size 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