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NCT01566695 · OUTCOME

Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 6 Day 1 (C6 D1)

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS) · Source last updated 2025-01-07

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
From Baseline to Cycle 6 Day 1 (C6 D1)

What was measured

The distribution (frequency and percentage) of the observed responses (i.e., "Not at all (0)," "A little bit (1)," "Somewhat (2)," "Quite a bit (3)," "Very much (4)," and missing) to Item GP-5 ("I am bothered by side effects of treatment" in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved \[i.e., change score from 1 to 4\], no change \[0\], worsened by one level \[-1\], worsened by ≥2 levels \[-2 to -4\], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group.

Analysis population: The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.

Groups in this outcome

Oral Azacitidine and Best Supportive Care

Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.

Placebo Plus Best Supportive Care

Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.

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 and Best Supportive Care81
Placebo Plus Best Supportive Care95

Reported measurements

Improved
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oral Azacitidine and Best Supportive Care1.2Not reportedNot reportedNot reportedNot reported
Placebo Plus Best Supportive Care4.2Not reportedNot reportedNot reportedNot reported
No Change
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oral Azacitidine and Best Supportive Care25.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Best Supportive Care27.4Not reportedNot reportedNot reportedNot reported
Worsened by 1 Level
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oral Azacitidine and Best Supportive Care9.9Not reportedNot reportedNot reportedNot reported
Placebo Plus Best Supportive Care12.6Not reportedNot reportedNot reportedNot reported
Worsened by 2 Levels
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oral Azacitidine and Best Supportive Care14.8Not reportedNot reportedNot reportedNot reported
Placebo Plus Best Supportive Care7.4Not reportedNot reportedNot reportedNot reported
Missing
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oral Azacitidine and Best Supportive Care48.1Not reportedNot reportedNot reportedNot reported
Placebo Plus Best Supportive Care48.4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.442
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.442
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.2
      2. group Id
        OG001
        value
        4.2
    title
    Improved
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        25.9
      2. group Id
        OG001
        value
        27.4
    title
    No Change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9.9
      2. group Id
        OG001
        value
        12.6
    title
    Worsened by 1 Level
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        14.8
      2. group Id
        OG001
        value
        7.4
    title
    Worsened by 2 Levels
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        48.1
      2. group Id
        OG001
        value
        48.4
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      95
    units
    Participants
description
The distribution (frequency and percentage) of the observed responses (i.e., "Not at all (0)," "A little bit (1)," "Somewhat (2)," "Quite a bit (3)," "Very much (4)," and missing) to Item GP-5 ("I am bothered by side effects of treatment" in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved \[i.e., change score from 1 to 4\], no change \[0\], worsened by one level \[-1\], worsened by ≥2 levels \[-2 to -4\], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group.
groups
  1. description
    Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
    id
    OG000
    title
    Oral Azacitidine and Best Supportive Care
  2. description
    Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
    id
    OG001
    title
    Placebo Plus Best Supportive Care
param Type
NUMBER
population Description
The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.
reporting Status
POSTED
time Frame
From Baseline to Cycle 6 Day 1 (C6 D1)
title
Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5 - Cycle 6 Day 1 (C6 D1)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice