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NCT00128102 · OUTCOME

Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12

Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014) · Source last updated 2020-10-26

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

Measure
MEAN
Unit
Percent Change
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Week 12

What was measured

LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percent change in the LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.

Analysis population: All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.

Groups in this outcome

Vorinostat

Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.

Placebo

Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Vorinostat299
Placebo299

Reported measurements

Source class 1
Values in Percent Change · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vorinostat141.8Not reported72.9210.8Not reported
Placebo174.7Not reported40.4308.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -143.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    38.6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.259
    param Type
    Difference in Percent Change
    param Value
    -52.4
    statistical Method
    Longitudinal Model
Complete source fields
analyses
  1. ci Lower Limit
    -143.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    38.6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.259
    param Type
    Difference in Percent Change
    param Value
    -52.4
    statistical Method
    Longitudinal Model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72.9
        upper Limit
        210.8
        value
        141.8
      2. group Id
        OG001
        lower Limit
        40.4
        upper Limit
        308.9
        value
        174.7
denoms
  1. counts
    1. group Id
      OG000
      value
      299
    2. group Id
      OG001
      value
      299
    units
    Participants
description
LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percent change in the LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
dispersion Type
95% Confidence Interval
groups
  1. description
    Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Vorinostat
  2. description
    Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
reporting Status
POSTED
time Frame
Baseline, Week 12
title
Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12
type
SECONDARY
unit Of Measure
Percent Change

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice