NCT00453310 · ADVERSE EVENTS

Adverse events

Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment · Source last updated 2015-10-27

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
Sunitinib Malate The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate	1 / 10	8 / 10	Not reported / Not reported

Group identifiers: EG000: Sunitinib Malate

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
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Hemorrhage, Abdomen NOS

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
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
term
ALT, SGPT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Glucose, high (hyperglycemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Hemorrhage, Nose
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
4
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
term
Mucositis (func/sympt)- Oral cavity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Neuropathy: motor
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Neuropathy: sensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Pain - Extremity-limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Rash/desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Urinary frequency/urgency

Complete source fields

event Groups

description
The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) sunitinib malate
id
EG000
other Num Affected
8
other Num At Risk
10
serious Num Affected
1
serious Num At Risk
10
title
Sunitinib Malate

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
term
ALT, SGPT
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Glucose, high (hyperglycemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Hemorrhage, Nose
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
4
num At Risk
10
num Events
4
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
2
num At Risk
10
num Events
2
term
Mucositis (func/sympt)- Oral cavity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Neuropathy: motor
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Neuropathy: sensory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Pain - Extremity-limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Rash/desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Urinary frequency/urgency

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTC-3.0
stats
group Id
EG000
num Affected
1
num At Risk
10
num Events
1
term
Hemorrhage, Abdomen NOS

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Preserved source evidence · Not medical advice