Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02195869 · OUTCOME

Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease · Source last updated 2019-07-11

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
95% Confidence Interval
Time frame
Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.

What was measured

Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in \>7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome.

Analysis population: All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose.

Groups in this outcome

Phase 1b/Phase 2

Subjects receive daily dose of 420 mg of Ibrutinib capsules

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

Analysis denominator · Participants

GroupSource count
Phase 1b/Phase 242

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b/Phase 242.9Not reported27.759Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.7
        upper Limit
        59
        value
        42.9
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    units
    Participants
description
Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in \>7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects receive daily dose of 420 mg of Ibrutinib capsules
    id
    OG000
    title
    Phase 1b/Phase 2
param Type
NUMBER
population Description
All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose.
reporting Status
POSTED
time Frame
Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
title
Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice