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NCT00833417 · OUTCOME

Change From Baseline in Short Form 36 (SF-36) Health Survey Scores

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma · Source last updated 2026-05-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Week 12, Week 24, and at the end of the study or early termination visit (up to the clinical cutoff date of 26 November 2010, up to 90 weeks)

What was measured

The SF-36 Health Survey (Version 2) uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.

Analysis population: Efficacy-evaluable population: All treated patients for whom the independent pathologist's interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma. Number analyzed (n) reflects the number of participants with both baseline and visit data available for a given timepoint.

Groups in this outcome

Metastatic and Locally Advanced Basal-Cell Carcinoma

Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Metastatic and Locally Advanced Basal-Cell Carcinoma82

Reported measurements

Change in MCS score at Week 12, n=82

Analysis denominator · Participants

GroupSource count
Metastatic and Locally Advanced Basal-Cell Carcinoma82
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Metastatic and Locally Advanced Basal-Cell Carcinoma2.20Not reported-0.224.62Not reported
Change in MCS score at Week 24, n=75

Analysis denominator · Participants

GroupSource count
Metastatic and Locally Advanced Basal-Cell Carcinoma75
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Metastatic and Locally Advanced Basal-Cell Carcinoma2.29Not reported0.054.53Not reported
Change in MCS score at end of study, n=20

Analysis denominator · Participants

GroupSource count
Metastatic and Locally Advanced Basal-Cell Carcinoma20
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Metastatic and Locally Advanced Basal-Cell Carcinoma-3.80Not reported-10.552.96Not reported
Change in PCS score at Week 12, n=82

Analysis denominator · Participants

GroupSource count
Metastatic and Locally Advanced Basal-Cell Carcinoma82
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Metastatic and Locally Advanced Basal-Cell Carcinoma-1.25Not reported-2.860.36Not reported
Change in PCS score at Week 24, n=75

Analysis denominator · Participants

GroupSource count
Metastatic and Locally Advanced Basal-Cell Carcinoma75
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Metastatic and Locally Advanced Basal-Cell Carcinoma-1.90Not reported-3.75-0.05Not reported
Change in PCS score at end of study, n=20

Analysis denominator · Participants

GroupSource count
Metastatic and Locally Advanced Basal-Cell Carcinoma20
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Metastatic and Locally Advanced Basal-Cell Carcinoma-2.86Not reported-7.391.66Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.22
        upper Limit
        4.62
        value
        2.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      units
      Participants
    title
    Change in MCS score at Week 12, n=82
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.05
        upper Limit
        4.53
        value
        2.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      units
      Participants
    title
    Change in MCS score at Week 24, n=75
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -10.55
        upper Limit
        2.96
        value
        -3.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Change in MCS score at end of study, n=20
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.86
        upper Limit
        0.36
        value
        -1.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      units
      Participants
    title
    Change in PCS score at Week 12, n=82
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.75
        upper Limit
        -0.05
        value
        -1.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      units
      Participants
    title
    Change in PCS score at Week 24, n=75
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.39
        upper Limit
        1.66
        value
        -2.86
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Change in PCS score at end of study, n=20
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    units
    Participants
description
The SF-36 Health Survey (Version 2) uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
    id
    OG000
    title
    Metastatic and Locally Advanced Basal-Cell Carcinoma
param Type
MEAN
population Description
Efficacy-evaluable population: All treated patients for whom the independent pathologist's interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma. Number analyzed (n) reflects the number of participants with both baseline and visit data available for a given timepoint.
reporting Status
POSTED
time Frame
Baseline, Week 12, Week 24, and at the end of the study or early termination visit (up to the clinical cutoff date of 26 November 2010, up to 90 weeks)
title
Change From Baseline in Short Form 36 (SF-36) Health Survey Scores
type
SECONDARY
unit Of Measure
Units on a scale

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

Preserved source evidence · Not medical advice