Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01074047 · OUTCOME

Kaplan-Meier Estimates for Overall Survival

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) · Source last updated 2017-08-29

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 (randomization) to 40 months

What was measured

Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.

Analysis population: The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored

Groups in this outcome

Azacitidine (AZA)

Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.

Conventional Care Regimens (CCR)

CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help

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

Analysis denominator · Participants

GroupSource count
Azacitidine (AZA)241
Conventional Care Regimens (CCR)247

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Azacitidine (AZA)10.4Not reported8.012.7Not reported
Conventional Care Regimens (CCR)6.5Not reported5.08.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    estimate Comment
    The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0829
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
    statistical Comment
    The p-value is two-sided from an unstratified log-rank test
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    estimate Comment
    The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1009
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    estimate Comment
    The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0829
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
    statistical Comment
    The p-value is two-sided from an unstratified log-rank test
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    estimate Comment
    The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1009
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.0
        upper Limit
        12.7
        value
        10.4
      2. group Id
        OG001
        lower Limit
        5.0
        upper Limit
        8.6
        value
        6.5
denoms
  1. counts
    1. group Id
      OG000
      value
      241
    2. group Id
      OG001
      value
      247
    units
    Participants
description
Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
    id
    OG000
    title
    Azacitidine (AZA)
  2. description
    CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help
    id
    OG001
    title
    Conventional Care Regimens (CCR)
param Type
MEDIAN
population Description
The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored
reporting Status
POSTED
time Frame
Day 1 (randomization) to 40 months
title
Kaplan-Meier Estimates for Overall Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice