Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02195869 · OUTCOME

Sustained Response Rate as the Percentage of Participants With Sustained Response

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

For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable.

Analysis population: Phase 2 subjects include all subjects who participated in phase 1b. Subjects evaluated for sustained response includes participants who had achieved an NIH-defined CR or PR.

Groups in this outcome

Phase1b/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
Phase1b/Phase 229

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase1b/Phase 269Not reported49.284.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.2
        upper Limit
        84.7
        value
        69
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects receive daily dose of 420 mg of Ibrutinib capsules
    id
    OG000
    title
    Phase1b/Phase 2
param Type
NUMBER
population Description
Phase 2 subjects include all subjects who participated in phase 1b. Subjects evaluated for sustained response includes participants who had achieved an NIH-defined CR or PR.
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
Sustained Response Rate as the Percentage of Participants With Sustained Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice