NCT00513474 · ADVERSE EVENTS

Adverse events

Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant · Source last updated 2017-05-25

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: Up to 71 months
Other-event reporting threshold: 4%

Safety population included all participants who received at least one dose of protocol specified treatment and were in remission at the time of transplant.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rasburicase Group Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.	10 / 21	21 / 21	Not reported / Not reported
Control Group Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.	9 / 21	21 / 21	Not reported / Not reported

Group identifiers: EG000: Rasburicase Group · EG001: Control Group

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
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Engraftment syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Venoocclusive disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
21
group Id
EG001
num Affected
7
num At Risk
21
term
Relapsed disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
21
group Id
EG001
num Affected
1
num At Risk
21
term
Infection from aGVHD flare
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
21
group Id
EG001
num Affected
1
num At Risk
21
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
H1N1 influenza
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Metapneumovirus

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
13
num At Risk
21
group Id
EG001
num Affected
11
num At Risk
21
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
5
num At Risk
21
group Id
EG001
num Affected
9
num At Risk
21
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
19
num At Risk
21
group Id
EG001
num Affected
19
num At Risk
21
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
15
num At Risk
21
group Id
EG001
num Affected
9
num At Risk
21
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
20
num At Risk
21
group Id
EG001
num Affected
17
num At Risk
21
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
2
num At Risk
21
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
5
num At Risk
21
group Id
EG001
num Affected
2
num At Risk
21
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Tongue numbness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Hemolytic anemia

Complete source fields

description

Safety population included all participants who received at least one dose of protocol specified treatment and were in remission at the time of transplant.

event Groups

description
Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
id
EG000
other Num Affected
21
other Num At Risk
21
serious Num Affected
10
serious Num At Risk
21
title
Rasburicase Group
description
Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
id
EG001
other Num Affected
21
other Num At Risk
21
serious Num Affected
9
serious Num At Risk
21
title
Control Group

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
13
num At Risk
21
group Id
EG001
num Affected
11
num At Risk
21
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
5
num At Risk
21
group Id
EG001
num Affected
9
num At Risk
21
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
19
num At Risk
21
group Id
EG001
num Affected
19
num At Risk
21
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
15
num At Risk
21
group Id
EG001
num Affected
9
num At Risk
21
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
20
num At Risk
21
group Id
EG001
num Affected
17
num At Risk
21
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
2
num At Risk
21
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
5
num At Risk
21
group Id
EG001
num Affected
2
num At Risk
21
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Tongue numbness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Hemolytic anemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Seizure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Engraftment syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Venoocclusive disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
7
num At Risk
21
group Id
EG001
num Affected
7
num At Risk
21
term
Relapsed disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
21
group Id
EG001
num Affected
1
num At Risk
21
term
Infection from aGVHD flare
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
21
group Id
EG001
num Affected
1
num At Risk
21
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
H1N1 influenza
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Resulted in death
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
21
group Id
EG001
num Affected
0
num At Risk
21
term
Metapneumovirus

time Frame

Up to 71 months

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

Preserved source evidence · Not medical advice