NCT00453206 · ADVERSE EVENTS

Adverse events

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases · Source last updated 2018-09-10

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: The only adverse events collected and analyzed for this study were grade 5 (death) related to transplant occurring within 6 months of transplant. No data was collected for less serious adverse events.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Reduced Intensity Allogeneic Cell Transplantation reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant	6 / 65	0 / 65	Not reported / Not reported

Group identifiers: EG000: Reduced Intensity Allogeneic Cell Transplantation

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
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
65
num Events
3
term
Graft versus host disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
Post transplant proliferative disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
Neurological unspecified
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cause of death could not be determined. Per study, this was considered related to transplant
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
Death of unknown cause

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

event Groups

description
reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
id
EG000
other Num Affected
0
other Num At Risk
65
serious Num Affected
6
serious Num At Risk
65
title
Reduced Intensity Allogeneic Cell Transplantation

frequency Threshold

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
65
num Events
3
term
Graft versus host disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
Post transplant proliferative disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
Neurological unspecified
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cause of death could not be determined. Per study, this was considered related to transplant
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
65
num Events
1
term
Death of unknown cause

time Frame

The only adverse events collected and analyzed for this study were grade 5 (death) related to transplant occurring within 6 months of transplant. No data was collected for less serious adverse events.

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

Preserved source evidence · Not medical advice