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NCT00073307 · OUTCOME

Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment

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
LEAST_SQUARES_MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Error
Time frame
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.

What was measured

Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.

Analysis population: Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.

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

Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]

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)451
Placebo452

Reported measurements

Cycle 2, Day 1
Values in Scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)21.210.17Not reportedNot reportedNot reported
Placebo21.160.19Not reportedNot reportedNot reported
Cycle 3, Day 1
Values in Scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)20.770.17Not reportedNot reportedNot reported
Placebo20.720.19Not reportedNot reportedNot reported
Cycle 4, Day 1
Values in Scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)20.330.19Not reportedNot reportedNot reported
Placebo20.280.22Not reportedNot reportedNot reported
Cycle 5, Day 1
Values in Scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)19.890.24Not reportedNot reportedNot reported
Placebo19.840.26Not reportedNot reportedNot reported
Cycles 1-5 (Overall)
Values in Scores on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)20.700.17Not reportedNot reportedNot reported
Placebo20.650.19Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.83
    statistical Comment
    Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.
    statistical Method
    random coefficient model
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.83
    statistical Comment
    Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.
    statistical Method
    random coefficient model
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.17
        value
        21.21
      2. group Id
        OG001
        spread
        0.19
        value
        21.16
    title
    Cycle 2, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.17
        value
        20.77
      2. group Id
        OG001
        spread
        0.19
        value
        20.72
    title
    Cycle 3, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.19
        value
        20.33
      2. group Id
        OG001
        spread
        0.22
        value
        20.28
    title
    Cycle 4, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.24
        value
        19.89
      2. group Id
        OG001
        spread
        0.26
        value
        19.84
    title
    Cycle 5, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.17
        value
        20.70
      2. group Id
        OG001
        spread
        0.19
        value
        20.65
    title
    Cycles 1-5 (Overall)
denoms
  1. counts
    1. group Id
      OG000
      value
      451
    2. group Id
      OG001
      value
      452
    units
    Participants
description
Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
dispersion Type
Standard Error
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
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    id
    OG001
    title
    Placebo
param Type
LEAST_SQUARES_MEAN
population Description
Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.
reporting Status
POSTED
time Frame
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
title
Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice