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NCT00071799 · OUTCOME

Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals

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
infections per treatment year
Interval / dispersion
Not reported
Time frame
Day 1 (randomization) to 42 months

What was measured

The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.

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
Azacitidine179
Conventional Care179

Reported measurements

Source class 1
Values in infections per treatment year · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine0.16Not reportedNot reportedNot reportedNot reported
Conventional Care0.24Not 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
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1327
    param Type
    Risk Ratio (RR)
    param Value
    0.67
    statistical Method
    exact binomial
Complete source fields
analyses
  1. ci Lower Limit
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1327
    param Type
    Risk Ratio (RR)
    param Value
    0.67
    statistical Method
    exact binomial
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.16
      2. group Id
        OG001
        value
        0.24
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.
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
Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals
type
SECONDARY
unit Of Measure
infections per treatment year

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

Preserved source evidence · Not medical advice