NCT00514137 · ADVERSE EVENTS

Adverse events

Sunitinib in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2014-05-28

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: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Kinase Inhibitor Therapy) Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	5 / 13	13 / 13	Not reported / Not reported

Group identifiers: EG000: Treatment (Kinase Inhibitor Therapy)

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Leukocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Protein urine positive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Dyspnea

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
MedDRA 10
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
9
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
8
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
6
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
5
num At Risk
13
num Events
6
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
5
num At Risk
13
num Events
5
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
11
num At Risk
13
num Events
19
term
Fatigue

Complete source fields

event Groups

description
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
5
serious Num At Risk
13
title
Treatment (Kinase Inhibitor Therapy)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
9
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
8
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
6
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
5
num At Risk
13
num Events
6
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
5
num At Risk
13
num Events
5
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
11
num At Risk
13
num Events
19
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Leukocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Protein urine positive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Renal failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Dyspnea

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