NCT02195869 · OUTCOME

Phase 1b: 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: 28 treatment days after last subject enrolled in Phase 1 dose level(s).

What was measured

Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib

Analysis population: Endpoint only includes Phase 1 data.

Subjects receive daily dose of 420 mg of Ibrutinib capsules for dose level 1

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: Dose Level 1	6
Phase 2	0

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1b: Dose Level 1	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

denoms

description

Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib

groups

param Type

COUNT_OF_PARTICIPANTS

population Description

Endpoint only includes Phase 1 data.

reporting Status

POSTED

time Frame

28 treatment days after last subject enrolled in Phase 1 dose level(s).

title

Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice