NCT03112603 · OUTCOME

Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) · Source last updated 2025-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: hours
Interval / dispersion: Full Range
Time frame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

What was measured

tmax was defined as the time to reach the maximum plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.

Analysis population: PAS. Only participants with available data were analyzed.

Groups in this outcome

Ruxolitinib

Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).

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
Ruxolitinib	20

Reported measurements

Day 1

Analysis denominator · Participants

Group	Source count
Ruxolitinib	20

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	0.833	Not reported	0.417	4.08	Not reported

Day 15

Analysis denominator · Participants

Group	Source count
Ruxolitinib	16

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	1.00	Not reported	0.417	2.00	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.417
upper Limit
4.08
value
0.833
denoms
counts
group Id
OG000
value
20
units
Participants
title
Day 1
categories
measurements
group Id
OG000
lower Limit
0.417
upper Limit
2.00
value
1.00
denoms
counts
group Id
OG000
value
16
units
Participants
title
Day 15

denoms

counts
group Id
OG000
value
20
units
Participants

description

dispersion Type

Full Range

groups

description
Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
id
OG000
title
Ruxolitinib

param Type

MEDIAN

population Description

PAS. Only participants with available data were analyzed.

reporting Status

POSTED

time Frame

Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose

title

Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses

type

SECONDARY

unit Of Measure

hours

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

Preserved source evidence · Not medical advice