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NCT02953678 · OUTCOME

Nonrelapse Mortality (NRM)

A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) · Source last updated 2021-11-24

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
From baseline to Months 6, 9, 12, and 24

What was measured

Defined as the proportion of subjects who died due to causes other than malignancy relapse.

Analysis population: Efficacy Evaluable Participants including all responders as of the data cutoff (02 JUL 2018).

Groups in this outcome

Ruxolitinib in Combination With Corticosteroids

Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.

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

Analysis denominator · Participants

GroupSource count
Ruxolitinib in Combination With Corticosteroids71

Reported measurements

6 months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids44.4Not reported32.555.7Not reported
9 months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids48.2Not reported35.859.5Not reported
12 months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids52.9Not reported39.664.5Not reported
24 months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids64.8Not reported46.078.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.5
        upper Limit
        55.7
        value
        44.4
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.8
        upper Limit
        59.5
        value
        48.2
    title
    9 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.6
        upper Limit
        64.5
        value
        52.9
    title
    12 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.0
        upper Limit
        78.5
        value
        64.8
    title
    24 months
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
Defined as the proportion of subjects who died due to causes other than malignancy relapse.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
    id
    OG000
    title
    Ruxolitinib in Combination With Corticosteroids
param Type
NUMBER
population Description
Efficacy Evaluable Participants including all responders as of the data cutoff (02 JUL 2018).
reporting Status
POSTED
time Frame
From baseline to Months 6, 9, 12, and 24
title
Nonrelapse Mortality (NRM)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice