NCT00544115 · ADVERSE EVENTS

Adverse events

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders · Source last updated 2026-06-02

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 assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 20 years.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Regimen I Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation	4 / 62	14 / 62	45 / 62
Regimen II Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. busulfan cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation	1 / 17	4 / 17	14 / 17
Regimen III Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. cyclosporine etoposide methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation	7 / 130	38 / 130	103 / 130
Regimen IV Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. cyclosporine fludarabine phosphate melphalan methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation	0 / 4	0 / 4	2 / 4
Regimen V Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation	3 / 40	10 / 40	32 / 40
Regimen VI Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. busulfan cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation	1 / 2	1 / 2	1 / 2

Group identifiers: EG000: Regimen I · EG001: Regimen II · EG002: Regimen III · EG003: Regimen IV · EG004: Regimen V · EG005: Regimen VI

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
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Coagulation - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/Bleeding - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Melena/GI bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
62
num Events
2
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Portal vein flow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Thrombotic microangiopathy for BMT studies, if specified by the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Cardiac General - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Cardiac troponin I (cTnI)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Edema

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
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Bone marrow cellularity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Coagulation - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
DIC (disseminated intravascular coagulation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Fibrinogen
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
2
num At Risk
130
num Events
2
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
3
num At Risk
130
num Events
3
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hematuria (in the absence of vaginal bleeding)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
62
num Events
4
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
8
num At Risk
130
num Events
8
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemoglobin for leukemia studies or bone marrow infiltrative/myelophthisic processes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage, pulmonary/upper respiratory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
62
num Events
2
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
4
num At Risk
130
num Events
5
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/Bleeding - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
6
num At Risk
130
num Events
6
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia

Complete source fields

event Groups

deaths Num Affected
45
deaths Num At Risk
62
description
Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
id
EG000
other Num Affected
14
other Num At Risk
62
serious Num Affected
4
serious Num At Risk
62
title
Regimen I
deaths Num Affected
14
deaths Num At Risk
17
description
Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. busulfan cyclophosphamide cyclosporine methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
id
EG001
other Num Affected
4
other Num At Risk
17
serious Num Affected
1
serious Num At Risk
17
title
Regimen II
deaths Num Affected
103
deaths Num At Risk
130
description
Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. cyclosporine etoposide methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
id
EG002
other Num Affected
38
other Num At Risk
130
serious Num Affected
7
serious Num At Risk
130
title
Regimen III
deaths Num Affected
2
deaths Num At Risk
4
description
Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. cyclosporine fludarabine phosphate melphalan methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
id
EG003
other Num Affected
0
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Regimen IV
deaths Num Affected
32
deaths Num At Risk
40
description
Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
id
EG004
other Num Affected
10
other Num At Risk
40
serious Num Affected
3
serious Num At Risk
40
title
Regimen V
deaths Num Affected
1
deaths Num At Risk
2
description
Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. busulfan cyclosporine fludarabine phosphate methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
id
EG005
other Num Affected
1
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Regimen VI

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Bone marrow cellularity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Coagulation - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
DIC (disseminated intravascular coagulation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Fibrinogen
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
2
num At Risk
130
num Events
2
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
3
num At Risk
130
num Events
3
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hematuria (in the absence of vaginal bleeding)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
62
num Events
4
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
8
num At Risk
130
num Events
8
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemoglobin for leukemia studies or bone marrow infiltrative/myelophthisic processes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage, pulmonary/upper respiratory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
62
num Events
2
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
4
num At Risk
130
num Events
5
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/Bleeding - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
6
num At Risk
130
num Events
6
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Coagulation - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/Bleeding - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Melena/GI bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
62
num Events
2
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Platelets for BMT studies, if specified in the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Portal vein flow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
1
num At Risk
130
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Thrombotic microangiopathy for BMT studies, if specified by the protocol.
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
0
num At Risk
62
num Events
0
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
40
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Cardiac General - Other (Specify, __)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Cardiac troponin I (cTnI)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
62
num Events
1
group Id
EG001
num Affected
0
num At Risk
17
num Events
0
group Id
EG002
num Affected
0
num At Risk
130
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
40
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
term
Edema

time Frame

Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 20 years.

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Preserved source evidence · Not medical advice