Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02195869 · OUTCOME

Phase 2: Overall Response Rate as the Percentage of Participants With 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

Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site).

Analysis population: Efficacy analyses were performed using the All-treated Population (N = 42)

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 242

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase1b/Phase 269Not reported52.982.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.9
        upper Limit
        82.4
        value
        69
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    units
    Participants
description
Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site).
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
Efficacy analyses were performed using the All-treated Population (N = 42)
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
Phase 2: Overall Response Rate as the Percentage of Participants With Response
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice