NCT00003816 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 1 year
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	11 / 55	25 / 55	30 / 55
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	10 / 69	35 / 69	36 / 69
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	62 / 199	100 / 199	150 / 199
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	6 / 23	6 / 23	19 / 23
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.	4 / 15	9 / 15	9 / 15

Group identifiers: EG000: BuCy · EG001: CyTBI · EG002: FluMel · EG003: VpCyTBI · EG004: Other

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
death due to transplant related causes before 1 year after BMT
organ System
Investigations
stats
group Id
EG000
num Affected
11
num At Risk
55
num Events
11
group Id
EG001
num Affected
10
num At Risk
69
num Events
10
group Id
EG002
num Affected
62
num At Risk
199
num Events
62
group Id
EG003
num Affected
6
num At Risk
23
num Events
6
group Id
EG004
num Affected
4
num At Risk
15
num Events
4
term
1 yr TRM

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
overall grade II to IV acute graft versus host disease
organ System
Blood and lymphatic system disorders
source Vocabulary
Glucksberg criteria
stats
group Id
EG000
num Affected
25
num At Risk
55
num Events
25
group Id
EG001
num Affected
35
num At Risk
69
num Events
35
group Id
EG002
num Affected
100
num At Risk
199
num Events
100
group Id
EG003
num Affected
6
num At Risk
23
num Events
6
group Id
EG004
num Affected
9
num At Risk
15
num Events
9
term
acute graft-versus-host disease

Complete source fields

event Groups

deaths Num Affected
30
deaths Num At Risk
55
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
EG000
other Num Affected
25
other Num At Risk
55
serious Num Affected
11
serious Num At Risk
55
title
BuCy
deaths Num Affected
36
deaths Num At Risk
69
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
EG001
other Num Affected
35
other Num At Risk
69
serious Num Affected
10
serious Num At Risk
69
title
CyTBI
deaths Num Affected
150
deaths Num At Risk
199
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
EG002
other Num Affected
100
other Num At Risk
199
serious Num Affected
62
serious Num At Risk
199
title
FluMel
deaths Num Affected
19
deaths Num At Risk
23
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
EG003
other Num Affected
6
other Num At Risk
23
serious Num Affected
6
serious Num At Risk
23
title
VpCyTBI
deaths Num Affected
9
deaths Num At Risk
15
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
EG004
other Num Affected
9
other Num At Risk
15
serious Num Affected
4
serious Num At Risk
15
title
Other

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
overall grade II to IV acute graft versus host disease
organ System
Blood and lymphatic system disorders
source Vocabulary
Glucksberg criteria
stats
group Id
EG000
num Affected
25
num At Risk
55
num Events
25
group Id
EG001
num Affected
35
num At Risk
69
num Events
35
group Id
EG002
num Affected
100
num At Risk
199
num Events
100
group Id
EG003
num Affected
6
num At Risk
23
num Events
6
group Id
EG004
num Affected
9
num At Risk
15
num Events
9
term
acute graft-versus-host disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
death due to transplant related causes before 1 year after BMT
organ System
Investigations
stats
group Id
EG000
num Affected
11
num At Risk
55
num Events
11
group Id
EG001
num Affected
10
num At Risk
69
num Events
10
group Id
EG002
num Affected
62
num At Risk
199
num Events
62
group Id
EG003
num Affected
6
num At Risk
23
num Events
6
group Id
EG004
num Affected
4
num At Risk
15
num Events
4
term
1 yr TRM

time Frame

1 year

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Preserved source evidence · Not medical advice