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NCT03112603 · OUTCOME

AUCinf 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
GEOMETRIC_MEAN
Unit
ng*hour/mL
Interval / dispersion
Geometric Coefficient of Variation
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

AUCinf was defined as the area under the concentration-time curve from time 0 to infinity. 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

GroupSource count
Ruxolitinib10

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Ruxolitinib10
Values in ng*hour/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ruxolitinib64232.7Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
Ruxolitinib0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.7
        value
        642
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Day 1
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
AUCinf was defined as the area under the concentration-time curve from time 0 to infinity. 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.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
    id
    OG000
    title
    Ruxolitinib
param Type
GEOMETRIC_MEAN
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
AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
type
SECONDARY
unit Of Measure
ng*hour/mL

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

Preserved source evidence · Not medical advice