NCT00054327 · ADVERSE EVENTS

Adverse events

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer · Source last updated 2013-07-24

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: Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
Other-event reporting threshold: 0%

"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Regimen A Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.	0 / 11	0 / 0	Not reported / Not reported
Regimen B-1 Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..	0 / 4	0 / 0	Not reported / Not reported
Regimen B-2 Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.	1 / 3	0 / 0	Not reported / Not reported
Regimen B-3 Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.	2 / 4	0 / 0	Not reported / Not reported
Regimen C Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.	2 / 10	0 / 0	Not reported / Not reported
Regimen D Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.	0 / 2	0 / 0	Not reported / Not reported

Group identifiers: EG000: Regimen A · EG001: Regimen B-1 · EG002: Regimen B-2 · EG003: Regimen B-3 · EG004: Regimen C · EG005: Regimen D

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Melena/GI bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Elevated Bilirubin associated with graft versus host disease (GVHD)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Memory loss
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Mood alteration-anxiety, agitation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Pleural effusion (non-malignant)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Hematuria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Death not associated with CTCAE term - Multi-organ failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Hypertension

Other reported adverse events

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

Complete source fields

description

"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).

event Groups

description
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
11
title
Regimen A
description
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
4
title
Regimen B-1
description
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
1
serious Num At Risk
3
title
Regimen B-2
description
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
id
EG003
other Num Affected
0
other Num At Risk
0
serious Num Affected
2
serious Num At Risk
4
title
Regimen B-3
description
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
id
EG004
other Num Affected
0
other Num At Risk
0
serious Num Affected
2
serious Num At Risk
10
title
Regimen C
description
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
id
EG005
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
2
title
Regimen D

frequency Threshold

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Melena/GI bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Elevated Bilirubin associated with graft versus host disease (GVHD)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Memory loss
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Edema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Mood alteration-anxiety, agitation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Pleural effusion (non-malignant)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Hematuria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Death not associated with CTCAE term - Multi-organ failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
11
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
10
group Id
EG005
num Affected
0
num At Risk
2
term
Hypertension

time Frame

Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.

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