NCT01808534 · ADVERSE EVENTS

Adverse events

Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors · Source last updated 2015-07-02

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: Up to 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Palifosfamide) Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	2 / 5	4 / 5	Not reported / Not reported

Group identifiers: EG000: Treatment (Palifosfamide)

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
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Hypoglycemia

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
5
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Insomnia

Complete source fields

event Groups

description
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
4
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
Treatment (Palifosfamide)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Edema limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
5
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Peripheral sensory neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Insomnia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Hypoglycemia

time Frame

Up to 2 years

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

Preserved source evidence · Not medical advice