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NCT03112603 · OUTCOME

Cumulative Incidence of Non-relapse Mortality (NRM)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Months 3, 6, 12, 18, 24, 30, and 36

What was measured

Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence.

Analysis population: FAS. 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).

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.

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 Therapy164

Reported measurements

Month 3

Analysis denominator · Participants

GroupSource count
Ruxolitinib165
Best Available Therapy164
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib5.45Not reported2.689.67Not reported
Best Available Therapy4.44Not reported1.968.48Not reported
Month 6

Analysis denominator · Participants

GroupSource count
Ruxolitinib152
Best Available Therapy146
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib9.13Not reported5.3414.15Not reported
Best Available Therapy6.43Not reported3.2811.03Not reported
Month 12

Analysis denominator · Participants

GroupSource count
Ruxolitinib143
Best Available Therapy137
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib15.30Not reported10.2621.26Not reported
Best Available Therapy15.12Not reported9.9421.30Not reported
Month 18

Analysis denominator · Participants

GroupSource count
Ruxolitinib128
Best Available Therapy118
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib15.93Not reported10.7821.98Not reported
Best Available Therapy16.48Not reported11.0622.84Not reported
Month 24

Analysis denominator · Participants

GroupSource count
Ruxolitinib121
Best Available Therapy114
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib17.83Not reported12.3724.10Not reported
Best Available Therapy19.22Not reported13.3625.90Not reported
Month 30

Analysis denominator · Participants

GroupSource count
Ruxolitinib117
Best Available Therapy109
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib17.83Not reported12.3724.10Not reported
Best Available Therapy19.22Not reported13.9426.67Not reported
Month 36

Analysis denominator · Participants

GroupSource count
Ruxolitinib114
Best Available Therapy106
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib17.83Not reported12.3724.10Not reported
Best Available Therapy22.0Not reported15.7328.96Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.68
        upper Limit
        9.67
        value
        5.45
      2. group Id
        OG001
        lower Limit
        1.96
        upper Limit
        8.48
        value
        4.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      2. group Id
        OG001
        value
        164
      units
      Participants
    title
    Month 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.34
        upper Limit
        14.15
        value
        9.13
      2. group Id
        OG001
        lower Limit
        3.28
        upper Limit
        11.03
        value
        6.43
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      2. group Id
        OG001
        value
        146
      units
      Participants
    title
    Month 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.26
        upper Limit
        21.26
        value
        15.30
      2. group Id
        OG001
        lower Limit
        9.94
        upper Limit
        21.30
        value
        15.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      2. group Id
        OG001
        value
        137
      units
      Participants
    title
    Month 12
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.78
        upper Limit
        21.98
        value
        15.93
      2. group Id
        OG001
        lower Limit
        11.06
        upper Limit
        22.84
        value
        16.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        118
      units
      Participants
    title
    Month 18
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.37
        upper Limit
        24.10
        value
        17.83
      2. group Id
        OG001
        lower Limit
        13.36
        upper Limit
        25.90
        value
        19.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        114
      units
      Participants
    title
    Month 24
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.37
        upper Limit
        24.10
        value
        17.83
      2. group Id
        OG001
        lower Limit
        13.94
        upper Limit
        26.67
        value
        19.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    Month 30
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.37
        upper Limit
        24.10
        value
        17.83
      2. group Id
        OG001
        lower Limit
        15.73
        upper Limit
        28.96
        value
        22.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        114
      2. group Id
        OG001
        value
        106
      units
      Participants
    title
    Month 36
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      164
    units
    Participants
description
Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence.
dispersion Type
95% Confidence Interval
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
param Type
NUMBER
population Description
FAS. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
Months 3, 6, 12, 18, 24, 30, and 36
title
Cumulative Incidence of Non-relapse Mortality (NRM)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice