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NCT00534430 · OUTCOME

Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared.

Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer · Source last updated 2026-06-03

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

Measure
NUMBER
Unit
percentage of relapse probability
Interval / dispersion
95% Confidence Interval
Time frame
Date of Transplant to Five Years post-Transplant. Estimate is at Five Years post-Transplant.

What was measured

Fine and Gray estimate of cumulative incidence of Relapse, with Death as the competing risk. Estimate is at five years post-transplant. Ninety-five percent confidence interval is by logit transformation of Greenwood variance to keep the interval within the probability space of 0% to 100%.

Groups in this outcome

AML/1CR

Acute Myelogenous Leukemia Transplanted in First Complete Remission

AML/R1

Acute Myelogenous Leukemia Transplanted in First Relapse

AML/IF

Acute Myelogenous Leukemia Transplanted in Induction Failure

Active ALL

Active Acute Lymphocytic Leukemia

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

Analysis denominator · Participants

GroupSource count
AML/1CR6
AML/R16
AML/IF10
Active ALL6

Reported measurements

Source class 1
Values in percentage of relapse probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AML/1CR0Not reported00Not reported
AML/R10Not reported00Not reported
AML/IF30Not reported965Not reported
Active ALL50Not reported1387Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Description
    Gray's estimate. (Fine and Gray). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.
    non Inferiority Type
    EQUIVALENCE
    p Value
    >0.05
    p Value Comment
    Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.
    param Type
    Median Difference (Net)
    param Value
    0
    statistical Comment
    No adjustments.
    statistical Method
    Gray's Test
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Gray's estimate. (Fine and Gray). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Comment
    Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.
    non Inferiority Type
    EQUIVALENCE
    p Value
    >0.05
    p Value Comment
    Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.
    param Type
    Median Difference (Net)
    param Value
    0
    statistical Comment
    No adjustments.
    statistical Method
    Gray's Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        9
        upper Limit
        65
        value
        30
      4. group Id
        OG003
        lower Limit
        13
        upper Limit
        87
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Fine and Gray estimate of cumulative incidence of Relapse, with Death as the competing risk. Estimate is at five years post-transplant. Ninety-five percent confidence interval is by logit transformation of Greenwood variance to keep the interval within the probability space of 0% to 100%.
dispersion Type
95% Confidence Interval
groups
  1. description
    Acute Myelogenous Leukemia Transplanted in First Complete Remission
    id
    OG000
    title
    AML/1CR
  2. description
    Acute Myelogenous Leukemia Transplanted in First Relapse
    id
    OG001
    title
    AML/R1
  3. description
    Acute Myelogenous Leukemia Transplanted in Induction Failure
    id
    OG002
    title
    AML/IF
  4. description
    Active Acute Lymphocytic Leukemia
    id
    OG003
    title
    Active ALL
param Type
NUMBER
reporting Status
POSTED
time Frame
Date of Transplant to Five Years post-Transplant. Estimate is at Five Years post-Transplant.
title
Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared.
type
PRIMARY
unit Of Measure
percentage of relapse probability

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Preserved source evidence · Not medical advice