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NCT00071799 · OUTCOME

Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee

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 to 42 months

What was measured

IWG 2000 Criteria: Pretreatment=hemoglobin \<100g/L or RBC transfusion-dependent, platelet count \<100x10\^9/L or platelet transfusion dependent, absolute neutrophil count \<1.5x10\^9/L. Erythroid response: Major-\>20g/L increase or transfusion independent. Minor- 10-20g/L increase or \>=50% decrease in transfusion requirements. Platelet response: Major-absolute increase of \>=30x10\^9/L or platelet transfusion independence. Minor-\>=50% increase. Neutrophil response: Major-\>=100% increase or an absolute increase of \>0.5x10\^9/L. Minor-\>=100% increase and absolute increase of \<0.5x10\^9/L.

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

Any Improvement n=177, 178
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine87Not reportedNot reportedNot reportedNot reported
Conventional Care51Not reportedNot reportedNot reportedNot reported
Erythroid Response - Major n=157, 160
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine62Not reportedNot reportedNot reportedNot reported
Conventional Care17Not reportedNot reportedNot reportedNot reported
Erythroid Response - Minor n=157, 160
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine2Not reportedNot reportedNot reportedNot reported
Conventional Care1Not reportedNot reportedNot reportedNot reported
Platelet Response - Major n=141, 129
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine46Not reportedNot reportedNot reportedNot reported
Conventional Care18Not reportedNot reportedNot reportedNot reported
Platelet Response - Minor n=138, 127
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine6Not reportedNot reportedNot reportedNot reported
Conventional Care4Not reportedNot reportedNot reportedNot reported
Neutrophil Response - Major n=131, 111
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine25Not reportedNot reportedNot reportedNot reported
Conventional Care20Not reportedNot reportedNot reportedNot reported
Neutrophil Response - Minor n=131, 111
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine5Not reportedNot reportedNot reportedNot reported
Conventional Care9Not 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
    Any Improvement
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
  2. ci Pct Value
    95
    group Description
    Erythroid Response - Major
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
  3. ci Pct Value
    95
    group Description
    Erythroid Response - Minor
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.6203
    statistical Method
    Fisher Exact
  4. ci Pct Value
    95
    group Description
    Platelet Response - Major
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0003
    statistical Method
    Fisher Exact
  5. ci Pct Value
    95
    group Description
    Platelet Response - Minor
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.7514
    statistical Method
    Fisher Exact
  6. ci Pct Value
    95
    group Description
    Neutrophil Response - Major
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.8695
    statistical Method
    Fisher Exact
  7. ci Pct Value
    95
    group Description
    Neutrophil Response - Minor
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1760
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    Any Improvement
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
  2. ci Pct Value
    95
    group Description
    Erythroid Response - Major
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
  3. ci Pct Value
    95
    group Description
    Erythroid Response - Minor
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.6203
    statistical Method
    Fisher Exact
  4. ci Pct Value
    95
    group Description
    Platelet Response - Major
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0003
    statistical Method
    Fisher Exact
  5. ci Pct Value
    95
    group Description
    Platelet Response - Minor
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.7514
    statistical Method
    Fisher Exact
  6. ci Pct Value
    95
    group Description
    Neutrophil Response - Major
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.8695
    statistical Method
    Fisher Exact
  7. ci Pct Value
    95
    group Description
    Neutrophil Response - Minor
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1760
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        51
    title
    Any Improvement n=177, 178
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        17
    title
    Erythroid Response - Major n=157, 160
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Erythroid Response - Minor n=157, 160
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        18
    title
    Platelet Response - Major n=141, 129
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
    title
    Platelet Response - Minor n=138, 127
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        20
    title
    Neutrophil Response - Major n=131, 111
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        9
    title
    Neutrophil Response - Minor n=131, 111
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
IWG 2000 Criteria: Pretreatment=hemoglobin \<100g/L or RBC transfusion-dependent, platelet count \<100x10\^9/L or platelet transfusion dependent, absolute neutrophil count \<1.5x10\^9/L. Erythroid response: Major-\>20g/L increase or transfusion independent. Minor- 10-20g/L increase or \>=50% decrease in transfusion requirements. Platelet response: Major-absolute increase of \>=30x10\^9/L or platelet transfusion independence. Minor-\>=50% increase. Neutrophil response: Major-\>=100% increase or an absolute increase of \>0.5x10\^9/L. Minor-\>=100% increase and absolute increase of \<0.5x10\^9/L.
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 to 42 months
title
Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice