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NCT02953678 · OUTCOME

Overall Response Rate (ORR) at Day 28

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From baseline to Day 28

What was measured

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).

Analysis population: Efficacy Evaluable Participants who had a CR, VGPR, or PR at Day 28 response assessment or other response assessments within ± 2 days of Day 28, on or before the start of new anti-GVHD therapy

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

Responders - CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids19Not reportedNot reportedNot reportedNot reported
Responders - VGPR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids7Not reportedNot reportedNot reportedNot reported
Responders - PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids13Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    42.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    66.8
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    param Type
    Exact method for binomial distributions
    param Value
    54.9
Complete source fields
analyses
  1. ci Lower Limit
    42.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    66.8
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    param Type
    Exact method for binomial distributions
    param Value
    54.9
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Responders - CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Responders - VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Responders - PR
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
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
COUNT_OF_PARTICIPANTS
population Description
Efficacy Evaluable Participants who had a CR, VGPR, or PR at Day 28 response assessment or other response assessments within ± 2 days of Day 28, on or before the start of new anti-GVHD therapy
reporting Status
POSTED
time Frame
From baseline to Day 28
title
Overall Response Rate (ORR) at Day 28
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice