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NCT00071799 · OUTCOME

Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care · Source last updated 2019-10-29

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
Day 1 (randomization) to 42 months

What was measured

Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.

Analysis population: Intent to treat population

Groups in this outcome

Azacitidine

Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.

Conventional Care

Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)

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

Analysis denominator · Participants

GroupSource count
Azacitidine111
Conventional Care114

Reported measurements

Baseline Dependent; On-Treatment Independent
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine50Not reportedNot reportedNot reportedNot reported
Conventional Care13Not reportedNot reportedNot reportedNot reported
Baseline Dependent; On-Treatment Dependent
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine61Not reportedNot reportedNot reportedNot reported
Conventional Care101Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Description
    The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        13
    title
    Baseline Dependent; On-Treatment Independent
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        101
    title
    Baseline Dependent; On-Treatment Dependent
denoms
  1. counts
    1. group Id
      OG000
      value
      111
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
groups
  1. description
    Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
    id
    OG000
    title
    Azacitidine
  2. description
    Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
    id
    OG001
    title
    Conventional Care
param Type
NUMBER
population Description
Intent to treat population
reporting Status
POSTED
time Frame
Day 1 (randomization) to 42 months
title
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice