NCT01220609 · OUTCOME

Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0

Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy · Source last updated 2019-08-08

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: Every cycle until completion of study treatment up to 30 days after stopping study treatment

Analysis population: Eligible and evaluable patients.

Groups in this outcome

Grade 0

Number of patients who did not experience the specified AE.

Grade 1 (CTCAE v 4.0)

Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0

Grade 2 (CTCAE v 4.0)

Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0

Grade 3 (CTCAE v 4.0)

Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0

Grade 4 (CTCAE v 4.0)

Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0

Grade 5 (CTCAE v 4.0)

Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0

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 0	23
Grade 1 (CTCAE v 4.0)	23
Grade 2 (CTCAE v 4.0)	23
Grade 3 (CTCAE v 4.0)	23
Grade 4 (CTCAE v 4.0)	23
Grade 5 (CTCAE v 4.0)	23

Reported measurements

Leukopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	5	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	17	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	8	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	2	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	10	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	17	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	16	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	19	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Mucositis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	20	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	15	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	7	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	18	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	10	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	10	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	19	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Musculoskeletal/Connective tissue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	19	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Myalgia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	20	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Perpheral sensory neuropathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	17	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Dizziness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	20	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Dyspnea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	19	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Alopecia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	13	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 4.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 4.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 4.0)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
6
group Id
OG003
value
5
group Id
OG004
value
2
group Id
OG005
value
0
title
Leukopenia
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
6
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
4
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
4
group Id
OG005
value
0
title
Neutropenia
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
10
group Id
OG002
value
6
group Id
OG003
value
5
group Id
OG004
value
0
group Id
OG005
value
0
title
Anemia
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
6
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Platelet count decreased
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Nausea
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Vomiting
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
title
Mucositis
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Constipation
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
5
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Diarrhea
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
10
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
title
Fatigue
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Anorexia

denoms

counts
group Id
OG000
value
23
group Id
OG001
value
23
group Id
OG002
value
23
group Id
OG003
value
23
group Id
OG004
value
23
group Id
OG005
value
23
units
Participants

groups

description
Number of patients who did not experience the specified AE.
id
OG000
title
Grade 0
description
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
id
OG001
title
Grade 1 (CTCAE v 4.0)
description
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
id
OG002
title
Grade 2 (CTCAE v 4.0)
description
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
id
OG003
title
Grade 3 (CTCAE v 4.0)
description
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
id
OG004
title
Grade 4 (CTCAE v 4.0)
description
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
id
OG005
title
Grade 5 (CTCAE v 4.0)

param Type

COUNT_OF_PARTICIPANTS

population Description

Eligible and evaluable patients.

reporting Status

POSTED

time Frame

Every cycle until completion of study treatment up to 30 days after stopping study treatment

title

Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice