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NCT03112603 · OUTCOME

Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
from Baseline to LPLV (approximately 5 years)

What was measured

Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy (e.g., hematologic abnormality that required transfusion or hematological stem cell support), or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period (either randomized or cross-over period).

Analysis population: Safety Set. Six participants in the BAT arm discontinued before receiving the first dose.

Groups in this outcome

Ruxolitinib

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

Best Available Therapy

Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.

Ruxolitinib Cross-Over Period

Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ruxolitinib165
Best Available Therapy158
Ruxolitinib Cross-Over Period70

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib165Not reportedNot reportedNot reportedNot reported
Best Available Therapy148Not reportedNot reportedNot reportedNot reported
Ruxolitinib Cross-Over Period70Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        165
      2. group Id
        OG001
        value
        148
      3. group Id
        OG002
        value
        70
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      158
    3. group Id
      OG002
      value
      70
    units
    Participants
description
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy (e.g., hematologic abnormality that required transfusion or hematological stem cell support), or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period (either randomized or cross-over period).
groups
  1. description
    Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
    id
    OG000
    title
    Ruxolitinib
  2. description
    Participants received best available therapies (BATs), including, but not limited to, extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, and ibrutinib based on the investigator's decision.
    id
    OG001
    title
    Best Available Therapy
  3. description
    Participants from the BAT arm at the end of Cycle 6 crossed over to ruxolitinib treatment.
    id
    OG002
    title
    Ruxolitinib Cross-Over Period
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Set. Six participants in the BAT arm discontinued before receiving the first dose.
reporting Status
POSTED
time Frame
from Baseline to LPLV (approximately 5 years)
title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice