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NCT00361140 · OUTCOME

Non-relapse Mortality

Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT) · Source last updated 2017-03-03

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
100 days

What was measured

The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.

Analysis population: Intent to treat

Groups in this outcome

AUC 6000

Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour

AUC 7500

Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour

AUC 9000

Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour

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

Analysis denominator · Participants

GroupSource count
AUC 600040
AUC 750029
AUC 90003

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AUC 60003Not reportedNot reportedNot reportedNot reported
AUC 75004Not reportedNot reportedNot reportedNot reported
AUC 90002Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    42.48
    group Description
    Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .07
    param Type
    Hazard Ratio (HR)
    param Value
    6.27
    statistical Comment
    Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.
    statistical Method
    Gray
Complete source fields
analyses
  1. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    42.48
    group Description
    Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .07
    param Type
    Hazard Ratio (HR)
    param Value
    6.27
    statistical Comment
    Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.
    statistical Method
    Gray
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      29
    3. group Id
      OG002
      value
      3
    units
    Participants
description
The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.
groups
  1. description
    Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    id
    OG000
    title
    AUC 6000
  2. description
    Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    id
    OG001
    title
    AUC 7500
  3. description
    Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m\^2 I.V. over 1 hour
    id
    OG002
    title
    AUC 9000
param Type
NUMBER
population Description
Intent to treat
reporting Status
POSTED
time Frame
100 days
title
Non-relapse Mortality
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice