NCT02195869 · OUTCOME

Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months

What was measured

Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib

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

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

Group	Source count
Phase 1b/Phase 2	42

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	42	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

denoms

description

Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib

groups

param Type

COUNT_OF_PARTICIPANTS

population Description

Phase 2 subjects includes all subjects who participated in Phase 1b

reporting Status

POSTED

time Frame

From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months

title

Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice