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NCT00627393 · OUTCOME

Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)

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
participants
Interval / dispersion
Not reported
Time frame
Measured within 6 hours after end of transfusion

Analysis population: Subjects who received granulocyte transfusions. Six subjects in the control group received granulocyte transfusions in violation of the protocol.

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 Arm6
Granulocyte Arm51

Reported measurements

No events reported
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Control Arm5Not reportedNot reportedNot reportedNot reported
Granulocyte Arm19Not reportedNot reportedNot reportedNot reported
Grade 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Control Arm0Not reportedNot reportedNot reportedNot reported
Granulocyte Arm7Not reportedNot reportedNot reportedNot reported
Grade 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Control Arm1Not reportedNot reportedNot reportedNot reported
Granulocyte Arm14Not reportedNot reportedNot reportedNot reported
Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Control Arm0Not reportedNot reportedNot reportedNot reported
Granulocyte Arm10Not reportedNot reportedNot reportedNot reported
Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Control Arm0Not reportedNot reportedNot reportedNot reported
Granulocyte Arm1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        19
    title
    No events reported
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
    title
    Grade 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        14
    title
    Grade 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        10
    title
    Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      51
    units
    Participants
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 received granulocyte transfusions. Six subjects in the control group received granulocyte transfusions in violation of the protocol.
reporting Status
POSTED
time Frame
Measured within 6 hours after end of transfusion
title
Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice