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NCT01757535 · OUTCOME

Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission · Source last updated 2025-07-08

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

Measure
NUMBER
Unit
Hospitalizations per person-years
Interval / dispersion
95% Confidence Interval
Time frame
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months

What was measured

HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.

Analysis population: Safety population includes all participants who received at least 1 dose of study drug.

Groups in this outcome

Oral Azacitidine Plus Best Supportive Care

Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.

Placebo Plus Best Supportive Care

Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.

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

Analysis denominator · Participants

GroupSource count
Oral Azacitidine Plus Best Supportive Care236
Placebo Plus Best Supportive Care233

Reported measurements

Source class 1
Values in Hospitalizations per person-years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Oral Azacitidine Plus Best Supportive Care0.36Not reported0.310.42Not reported
Placebo Plus Best Supportive Care0.63Not reported0.540.74Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.31
        upper Limit
        0.42
        value
        0.36
      2. group Id
        OG001
        lower Limit
        0.54
        upper Limit
        0.74
        value
        0.63
denoms
  1. counts
    1. group Id
      OG000
      value
      236
    2. group Id
      OG001
      value
      233
    units
    Participants
description
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
    id
    OG000
    title
    Oral Azacitidine Plus Best Supportive Care
  2. description
    Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
    id
    OG001
    title
    Placebo Plus Best Supportive Care
param Type
NUMBER
population Description
Safety population includes all participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
title
Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year
type
SECONDARY
unit Of Measure
Hospitalizations per person-years

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

Preserved source evidence · Not medical advice