NCT01233921 · ADVERSE EVENTS

Adverse events

Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2014-04-02

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Palifermin) Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.	0 / 3	3 / 3	Not reported / Not reported
Arm II (no Palifermin) Patients do not receive palifermin.	0 / 3	2 / 3	Not reported / Not reported

Group identifiers: EG000: Arm I (Palifermin) · EG001: Arm II (no Palifermin)

Serious adverse events

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

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
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
pruritis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hyperkeratosis and taste changes
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
oral mucosal change
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
diarrhea

Complete source fields

event Groups

description
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Arm I (Palifermin)
description
Patients do not receive palifermin.
id
EG001
other Num Affected
2
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Arm II (no Palifermin)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
pruritis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Hyperkeratosis and taste changes
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
oral mucosal change
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
term
vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
term
diarrhea

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

Preserved source evidence · Not medical advice