NCT01495598 · ADVERSE EVENTS

Adverse events

Pomalidomide for Kaposi Sarcoma in People With or Without HIV · Source last updated 2022-11-01

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: Date treatment consent signed to date off study, approximately 124 months and 1 day.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pomalidomide 5mg Daily All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.	12 / 28	28 / 28	4 / 28

Group identifiers: EG000: Pomalidomide 5mg Daily

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
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
term
Death Not otherwise specified (NOS)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Enterocolitis infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Fever

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
9
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
28
num Events
47
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
28
num Events
12
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
3
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Amylase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Anal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
22
num At Risk
28
num Events
61
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
5
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
28
num Events
7
term
Arthralgia

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
28
description
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
id
EG000
other Num Affected
28
other Num At Risk
28
serious Num Affected
12
serious Num At Risk
28
title
Pomalidomide 5mg Daily

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
9
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
16
num At Risk
28
num Events
47
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
28
num Events
12
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
3
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Amylase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Anal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
22
num At Risk
28
num Events
61
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
5
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
28
num Events
7
term
Arthralgia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
4
term
Death Not otherwise specified (NOS)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Enterocolitis infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Fever

time Frame

Date treatment consent signed to date off study, approximately 124 months and 1 day.

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Preserved source evidence · Not medical advice