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NCT00071799 · OUTCOME

Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause

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
months
Interval / dispersion
Not reported
Time frame
Day 1 (randomization) to 42 months

What was measured

Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact. Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification.

Analysis population: Intent to treat population. Includes participants who died and those who were censored.

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

Age <65 years
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine11.31Not reportedNot reportedNot reportedNot reported
Conventional Care7.87Not reportedNot reportedNot reportedNot reported
Age >= 65 years
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine24.46Not reportedNot reportedNot reportedNot reported
Conventional Care13.87Not reportedNot reportedNot reportedNot reported
Age >= 75 years
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine8.92Not reportedNot reportedNot reportedNot reported
Conventional Care6.20Not reportedNot reportedNot reportedNot reported
Gender: Male
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine24.46Not reportedNot reportedNot reportedNot reported
Conventional Care15.02Not reportedNot reportedNot reportedNot reported
Gender: Female
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine25.11Not reportedNot reportedNot reportedNot reported
Conventional Care14.85Not reportedNot reportedNot reportedNot reported
FAB: Refractory anemia with excess blasts (RAEB)
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine34.66Not reportedNot reportedNot reportedNot reported
Conventional Care15.21Not reportedNot reportedNot reportedNot reported
FAB: RAEB in transformation
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine17.25Not reportedNot reportedNot reportedNot reported
Conventional Care15.25Not reportedNot reportedNot reportedNot reported
WHO: RAEB 1
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine11.54Not reportedNot reportedNot reportedNot reported
Conventional Care6.72Not reportedNot reportedNot reportedNot reported
WHO: RAEB 2
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine21.11Not reportedNot reportedNot reportedNot reported
Conventional Care15.02Not reportedNot reportedNot reportedNot reported
WHO: Other (AML, CMMoL-1 and 2, indeterminate)
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine20.46Not reportedNot reportedNot reportedNot reported
Conventional Care15.25Not reportedNot reportedNot reportedNot reported
IPSS: Intermediate 2
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine34.66Not reportedNot reportedNot reportedNot reported
Conventional Care16.89Not reportedNot reportedNot reportedNot reported
IPSS: High
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine19.21Not reportedNot reportedNot reportedNot reported
Conventional Care14.52Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Age \< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented. Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 7.1 months and high range of 15.6 months. Conventional Care: low range of 4.4 and high range of 12.4 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3973
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  2. group Description
    Age \>= 65 years Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 17.1 months and high range of 34.7 months. Conventional Care: low range of 8.8 and high range of 16.4 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  3. group Description
    Age \>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented. Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 1.7 months and high range of 15.0 months. Conventional Care: low range of 4.1 and high range of 7.6 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0707
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  4. group Description
    Gender: Male Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 17.9 months and high range of 'does not exist'. Conventional Care: low range of 10.8 and high range of 17.2 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0042
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  5. group Description
    Gender: Female Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 13.0 months and high range of 'does not exist'. Conventional Care: low range of 8.2 and high range of 17.6 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0469
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  6. ci Pct Value
    95
    group Description
    FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0056
    p Value Comment
    95% CI ranges are added here. Azacitidine: low range of 21.1 months and high range of 'does not exist'. Conventional Care: low range of 9.3 and high range of 21.9 months.
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
    statistical Method
    Log Rank
  7. ci Pct Value
    95
    group Description
    FAB: RAEB in transformation Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 11.7 months and high range of 'does not exist'. Conventional Care: low range of 9.4 and high range of 17.0 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0322
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  8. ci Pct Value
    95
    group Description
    WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented. Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 6.6 months and high range of 'does not exist'. Conventional Care: low range of 1.8 and high range of 9.8 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1679
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  9. ci Pct Value
    95
    group Description
    WHO: RAEB-2 Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 15.9 months and high range of 'does not exist'. Conventional Care: low range of 8.8 and high range of 19.4 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0692
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  10. ci Pct Value
    95
    group Description
    WHO: Other Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 15.6 months and high range of 'does not exist'. Conventional Care: low range of 11.1 and high range of 17.5 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0017
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  11. ci Pct Value
    95
    group Description
    IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1030
    p Value Comment
    95% CI ranges are added here. Azacitidine: low range of 17.1 months and high range of 'does not exist'. Conventional Care: low range of 8.7 and high range of 24.1 months.
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
    statistical Method
    Log Rank
  12. ci Pct Value
    95
    group Description
    IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0020
    p Value Comment
    95% CI ranges are added here. Azacitidine: low range of 15.0 months and high range of 'does not exist'. Conventional Care: low range of 9.0 and high range of 17.0 months.
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    Age \< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented. Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 7.1 months and high range of 15.6 months. Conventional Care: low range of 4.4 and high range of 12.4 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3973
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  2. group Description
    Age \>= 65 years Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 17.1 months and high range of 34.7 months. Conventional Care: low range of 8.8 and high range of 16.4 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  3. group Description
    Age \>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented. Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 1.7 months and high range of 15.0 months. Conventional Care: low range of 4.1 and high range of 7.6 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0707
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  4. group Description
    Gender: Male Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 17.9 months and high range of 'does not exist'. Conventional Care: low range of 10.8 and high range of 17.2 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0042
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  5. group Description
    Gender: Female Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 13.0 months and high range of 'does not exist'. Conventional Care: low range of 8.2 and high range of 17.6 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0469
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  6. ci Pct Value
    95
    group Description
    FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0056
    p Value Comment
    95% CI ranges are added here. Azacitidine: low range of 21.1 months and high range of 'does not exist'. Conventional Care: low range of 9.3 and high range of 21.9 months.
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
    statistical Method
    Log Rank
  7. ci Pct Value
    95
    group Description
    FAB: RAEB in transformation Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 11.7 months and high range of 'does not exist'. Conventional Care: low range of 9.4 and high range of 17.0 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0322
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  8. ci Pct Value
    95
    group Description
    WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented. Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 6.6 months and high range of 'does not exist'. Conventional Care: low range of 1.8 and high range of 9.8 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1679
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  9. ci Pct Value
    95
    group Description
    WHO: RAEB-2 Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 15.9 months and high range of 'does not exist'. Conventional Care: low range of 8.8 and high range of 19.4 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0692
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  10. ci Pct Value
    95
    group Description
    WHO: Other Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here. Azacitidine: low range of 15.6 months and high range of 'does not exist'. Conventional Care: low range of 11.1 and high range of 17.5 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0017
    p Value Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
  11. ci Pct Value
    95
    group Description
    IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1030
    p Value Comment
    95% CI ranges are added here. Azacitidine: low range of 17.1 months and high range of 'does not exist'. Conventional Care: low range of 8.7 and high range of 24.1 months.
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
    statistical Method
    Log Rank
  12. ci Pct Value
    95
    group Description
    IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0020
    p Value Comment
    95% CI ranges are added here. Azacitidine: low range of 15.0 months and high range of 'does not exist'. Conventional Care: low range of 9.0 and high range of 17.0 months.
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11.31
      2. group Id
        OG001
        value
        7.87
    title
    Age <65 years
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24.46
      2. group Id
        OG001
        value
        13.87
    title
    Age >= 65 years
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8.92
      2. group Id
        OG001
        value
        6.20
    title
    Age >= 75 years
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        24.46
      2. group Id
        OG001
        value
        15.02
    title
    Gender: Male
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        25.11
      2. group Id
        OG001
        value
        14.85
    title
    Gender: Female
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        34.66
      2. group Id
        OG001
        value
        15.21
    title
    FAB: Refractory anemia with excess blasts (RAEB)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        17.25
      2. group Id
        OG001
        value
        15.25
    title
    FAB: RAEB in transformation
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        11.54
      2. group Id
        OG001
        value
        6.72
    title
    WHO: RAEB 1
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        21.11
      2. group Id
        OG001
        value
        15.02
    title
    WHO: RAEB 2
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        20.46
      2. group Id
        OG001
        value
        15.25
    title
    WHO: Other (AML, CMMoL-1 and 2, indeterminate)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        34.66
      2. group Id
        OG001
        value
        16.89
    title
    IPSS: Intermediate 2
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        19.21
      2. group Id
        OG001
        value
        14.52
    title
    IPSS: High
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact. Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification.
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. Includes participants who died and those who were censored.
reporting Status
POSTED
time Frame
Day 1 (randomization) to 42 months
title
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause
type
PRIMARY
unit Of Measure
months

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