NCT00448357 · OUTCOME

Overall Survival

Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen · Source last updated 2017-07-17

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Three years post-transplant

What was measured

Percentage of participants alive at 3 years post transplant

Analysis population: Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.

Groups in this outcome

Low Busulfan AUC Tertile (5078)

Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min

Intermediate Busulfan AUC Tertile (6372)

Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min

High Busulfan AUC Tertile (7605)

Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min

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

Analysis denominator · Participants

Group	Source count
Low Busulfan AUC Tertile (5078)	18
Intermediate Busulfan AUC Tertile (6372)	18
High Busulfan AUC Tertile (7605)	18

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Low Busulfan AUC Tertile (5078)	28	Not reported	Not reported	Not reported	Not reported
Intermediate Busulfan AUC Tertile (6372)	39	Not reported	Not reported	Not reported	Not reported
High Busulfan AUC Tertile (7605)	55	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
28
group Id
OG001
value
39
group Id
OG002
value
55

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
18
group Id
OG002
value
18
units
Participants

description

Percentage of participants alive at 3 years post transplant

groups

description
Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
id
OG000
title
Low Busulfan AUC Tertile (5078)
description
Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
id
OG001
title
Intermediate Busulfan AUC Tertile (6372)
description
Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
id
OG002
title
High Busulfan AUC Tertile (7605)

param Type

NUMBER

population Description

Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.

reporting Status

POSTED

time Frame

Three years post-transplant

title

Overall Survival

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice