NCT01495598 · OUTCOME

Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day.

What was measured

Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening.

Groups in this outcome

Grade 1

Grade 1 is mild.

Grade 2

Grade 2 is moderate.

Grade 3

Grade 3 is severe.

Grade 4

Grade 4 is life-threatening.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Grade 1	28
Grade 2	28
Grade 3	28
Grade 4	28

Reported measurements

Low white cell count

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	21	Not reported	Not reported	Not reported	Not reported
Grade 2	10	Not reported	Not reported	Not reported	Not reported
Grade 3	1	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Febrile neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	0	Not reported	Not reported	Not reported	Not reported
Grade 2	0	Not reported	Not reported	Not reported	Not reported
Grade 3	1	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	24	Not reported	Not reported	Not reported	Not reported
Grade 2	26	Not reported	Not reported	Not reported	Not reported
Grade 3	14	Not reported	Not reported	Not reported	Not reported
Grade 4	3	Not reported	Not reported	Not reported	Not reported

Lymphocytopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	13	Not reported	Not reported	Not reported	Not reported
Grade 2	2	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	16	Not reported	Not reported	Not reported	Not reported
Grade 2	4	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	16	Not reported	Not reported	Not reported	Not reported
Grade 2	0	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	17	Not reported	Not reported	Not reported	Not reported
Grade 2	2	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	0	Not reported	Not reported	Not reported	Not reported
Grade 2	7	Not reported	Not reported	Not reported	Not reported
Grade 3	1	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	18	Not reported	Not reported	Not reported	Not reported
Grade 2	3	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	10	Not reported	Not reported	Not reported	Not reported
Grade 2	0	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Elevated alanine aminotransferase (ALT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	7	Not reported	Not reported	Not reported	Not reported
Grade 2	0	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Impaired concentration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	3	Not reported	Not reported	Not reported	Not reported
Grade 2	1	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Depression

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	1	Not reported	Not reported	Not reported	Not reported
Grade 2	1	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Hypothyroidism

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	3	Not reported	Not reported	Not reported	Not reported
Grade 2	3	Not reported	Not reported	Not reported	Not reported
Grade 3	0	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Rash

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	18	Not reported	Not reported	Not reported	Not reported
Grade 2	6	Not reported	Not reported	Not reported	Not reported
Grade 3	1	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Vasculitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 1	0	Not reported	Not reported	Not reported	Not reported
Grade 2	0	Not reported	Not reported	Not reported	Not reported
Grade 3	1	Not reported	Not reported	Not reported	Not reported
Grade 4	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
21
group Id
OG001
value
10
group Id
OG002
value
1
group Id
OG003
value
0
title
Low white cell count
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Febrile neutropenia
categories
measurements
group Id
OG000
value
24
group Id
OG001
value
26
group Id
OG002
value
14
group Id
OG003
value
3
title
Neutropenia
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
0
title
Lymphocytopenia
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
0
title
Anemia
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
0
title
Fatigue
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
0
title
Infection
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
0
title
Constipation
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Nausea
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Elevated alanine aminotransferase (ALT)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Impaired concentration

denoms

counts
group Id
OG000
value
28
group Id
OG001
value
28
group Id
OG002
value
28
group Id
OG003
value
28
units
Participants

description

groups

description
Grade 1 is mild.
id
OG000
title
Grade 1
description
Grade 2 is moderate.
id
OG001
title
Grade 2
description
Grade 3 is severe.
id
OG002
title
Grade 3
description
Grade 4 is life-threatening.
id
OG003
title
Grade 4

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day.

title

Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice