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NCT02195869 · OUTCOME

To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)

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
MEDIAN
Unit
Median
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 interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable.

Analysis population: Phase 2 subjects includes all subjects who participated in Phase 1b

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 Median · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase1b/Phase 2NANot reportedNANANA means not achieved or not estimable.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA means not achieved or not estimable.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable.
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
MEDIAN
population Description
Phase 2 subjects includes all subjects who participated in Phase 1b
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
To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Median

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

Preserved source evidence · Not medical advice