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NCT00627393 · OUTCOME

Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation

Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study) · Source last updated 2015-04-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
proportion of subjects, GVHD incidnence
Interval / dispersion
Not reported
Time frame
Measured at Day 42

What was measured

Time to GVHD incidence between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.

Analysis population: Subjects who had allogeneic stem cell transplantation

Groups in this outcome

Control Arm

Received antimicrobial therapy alone.

Granulocyte Arm

Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.

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

Analysis denominator · Participants

GroupSource count
Control Arm8
Granulocyte Arm7

Reported measurements

Source class 1
Values in proportion of subjects, GVHD incidnence · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Control Arm0.67Not reportedNot reportedNot reportedNot reported
Granulocyte Arm0.40Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.43
    p Value Comment
    Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).
    param Type
    Log Rank P-Value
    param Value
    0.43
    statistical Method
    Competing Risks
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.43
    p Value Comment
    Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).
    param Type
    Log Rank P-Value
    param Value
    0.43
    statistical Method
    Competing Risks
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.67
      2. group Id
        OG001
        value
        0.40
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Time to GVHD incidence between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.
groups
  1. description
    Received antimicrobial therapy alone.
    id
    OG000
    title
    Control Arm
  2. description
    Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
    id
    OG001
    title
    Granulocyte Arm
param Type
NUMBER
population Description
Subjects who had allogeneic stem cell transplantation
reporting Status
POSTED
time Frame
Measured at Day 42
title
Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation
type
SECONDARY
unit Of Measure
proportion of subjects, GVHD incidnence

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

Preserved source evidence · Not medical advice