NCT00003816 · OUTCOME

Toxicity/TRM at Day 100

Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer · Source last updated 2021-08-13

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Day +100

What was measured

Death due to treatment related causes before day +100 after BMT

Groups in this outcome

BuCy

Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. busulfan: Given IV cyclophosphamide: Given IV

CyTBI

Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. cyclophosphamide: Given IV total-body irradiation: Given twice daily for 3 days

FluMel

Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. fludarabine phosphate: Given IV melphalan: Given IV

VpCyTBI

Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. cyclophosphamide: Given IV etoposide: Given IV total-body irradiation: Given twice daily for 3 days

Other

Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.

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
BuCy	55
CyTBI	69
FluMel	199
VpCyTBI	23
Other	15

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
BuCy	3	Not reported	Not reported	Not reported	Not reported
CyTBI	4	Not reported	Not reported	Not reported	Not reported
FluMel	31	Not reported	Not reported	Not reported	Not reported
VpCyTBI	4	Not reported	Not reported	Not reported	Not reported
Other	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
31
group Id
OG003
value
4
group Id
OG004
value
4

denoms

counts
group Id
OG000
value
55
group Id
OG001
value
69
group Id
OG002
value
199
group Id
OG003
value
23
group Id
OG004
value
15
units
Participants

description

Death due to treatment related causes before day +100 after BMT

groups

description
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. busulfan: Given IV cyclophosphamide: Given IV
id
OG000
title
BuCy
description
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. cyclophosphamide: Given IV total-body irradiation: Given twice daily for 3 days
id
OG001
title
CyTBI
description
Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. fludarabine phosphate: Given IV melphalan: Given IV
id
OG002
title
FluMel
description
Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. cyclophosphamide: Given IV etoposide: Given IV total-body irradiation: Given twice daily for 3 days
id
OG003
title
VpCyTBI
description
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. OR Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. OR Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. OR Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. OR Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
id
OG004
title
Other

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Day +100

title

Toxicity/TRM at Day 100

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice