Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00073307 · OUTCOME

Best Overall Response - Independent Radiological Review

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer · Source last updated 2014-02-06

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 start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.

What was measured

Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.

Analysis population: Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.

Groups in this outcome

Sorafenib (Nexavar, BAY43-9006)

Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.

Placebo

Placebo tablets matching in appearance were to be orally administered twice a day.

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)335
Placebo337

Reported measurements

Complete Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)0.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)2.1Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)77.9Not reportedNot reportedNot reportedNot reported
Placebo55.2Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)8.7Not reportedNot reportedNot reportedNot reported
Placebo30.3Not reportedNot reportedNot reportedNot reported
Not Evaluated
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)11.3Not reportedNot reportedNot reportedNot reported
Placebo14.5Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -3.7
    ci Pct Value
    95
    ci Upper Limit
    -0.6
    estimate Comment
    difference in response rates (CR+PR) = Placebo - Sorafenib
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Difference in response rates (CR+PR)
    param Value
    -2.1
    statistical Comment
    Adjustments for country and Motzer category
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -3.7
    ci Pct Value
    95
    ci Upper Limit
    -0.6
    estimate Comment
    difference in response rates (CR+PR) = Placebo - Sorafenib
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Difference in response rates (CR+PR)
    param Value
    -2.1
    statistical Comment
    Adjustments for country and Motzer category
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2.1
      2. group Id
        OG001
        value
        0.0
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        77.9
      2. group Id
        OG001
        value
        55.2
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8.7
      2. group Id
        OG001
        value
        30.3
    title
    Progressive Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11.3
      2. group Id
        OG001
        value
        14.5
    title
    Not Evaluated
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    2. group Id
      OG001
      value
      337
    units
    Participants
description
Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.
groups
  1. description
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    id
    OG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Placebo tablets matching in appearance were to be orally administered twice a day.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.
reporting Status
POSTED
time Frame
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
title
Best Overall Response - Independent Radiological Review
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice