NCT01350245 · ADVERSE EVENTS

Adverse events

Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor · Source last updated 2025-05-16

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
TJU 2 Step Regimen All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone. Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy). Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days. Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD) Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD) Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do	19 / 28	28 / 28	Not reported / Not reported

Group identifiers: EG000: TJU 2 Step Regimen

Serious adverse events

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

organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Bone marrow cellularity
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Infection
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
term
Diarrhea
organ System
General disorders
stats
group Id
EG000
num Affected
8
num At Risk
28
num Events
10
term
Fever
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Headache
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Colitis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
term
CMV reactivation
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
BK cystitis
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Nausea
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
HHV-6 infection
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Subdural hematoma
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Brain injury from subdural hematoma

Other reported adverse events

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

organ System
General disorders
stats
group Id
EG000
num Affected
18
num At Risk
28
num Events
30
term
Headache
organ System
General disorders
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
7
term
Decreased appetite
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
19
num At Risk
28
num Events
22
term
Anxiety
organ System
General disorders
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
8
term
Rigors
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
20
num At Risk
28
num Events
35
term
Tachycardia
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Malaise
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Oral discomfort
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
term
Sore throat
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
23
num At Risk
28
num Events
52
term
Rash
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Ulcer
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Palpitations
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Rectal pain

Complete source fields

event Groups

description
All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone. Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy). Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days. Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD) Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD) Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
id
EG000
other Num Affected
28
other Num At Risk
28
serious Num Affected
19
serious Num At Risk
28
title
TJU 2 Step Regimen

frequency Threshold

other Events

organ System
General disorders
stats
group Id
EG000
num Affected
18
num At Risk
28
num Events
30
term
Headache
organ System
General disorders
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
7
term
Decreased appetite
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
19
num At Risk
28
num Events
22
term
Anxiety
organ System
General disorders
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
8
term
Rigors
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
20
num At Risk
28
num Events
35
term
Tachycardia
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Malaise
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Oral discomfort
organ System
General disorders
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
term
Sore throat
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
23
num At Risk
28
num Events
52
term
Rash
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Ulcer
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Palpitations
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Rectal pain

serious Events

organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Bone marrow cellularity
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Infection
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
term
Diarrhea
organ System
General disorders
stats
group Id
EG000
num Affected
8
num At Risk
28
num Events
10
term
Fever
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Headache
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Colitis
organ System
Immune system disorders
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
term
CMV reactivation
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
BK cystitis
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Nausea
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
HHV-6 infection
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Subdural hematoma
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Brain injury from subdural hematoma

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Preserved source evidence · Not medical advice