NCT00025233 · OUTCOME

Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0

Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix · Source last updated 2019-07-24

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 and 30 days after the end of treatment. (average 5 months)

What was measured

The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.

Analysis population: Eligible and treated patients

Groups in this outcome

Grade 0

Number of patients who did not experience the specified AE.

Grade 1 (CTCAE v 2.0)

Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0

Grade 2 (CTCAE v 2.0)

Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0

Grade 3 (CTCAE v 2.0)

Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0

Grade 4 (CTCAE v 2.0)

Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0

Grade 5 (CTCAE v 2.0)

Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0

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	46
Grade 1 (CTCAE v 2.0)	46
Grade 2 (CTCAE v 2.0)	46
Grade 3 (CTCAE v 2.0)	46
Grade 4 (CTCAE v 2.0)	46
Grade 5 (CTCAE v 2.0)	46

Reported measurements

Leukopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	39	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	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	43	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	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	42	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	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	26	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	8	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	10	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Other hematologic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	41	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Allergy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	45	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	33	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	7	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Thrombosis Embolism

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	41	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	4	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Other cardiovascular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	34	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	8	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Coagulation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	43	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Constitutional

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	22	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	16	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Dermatologic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	36	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	25	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	7	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	10	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Genitourinary/renal

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	34	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	38	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Hepatic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	35	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	11	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	40	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported

Metabolic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	29	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	16	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Neuropathy sensory

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	41	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Other neurologic

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	41	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	3	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	27	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	8	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	6	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Pulmonary

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Grade 0	38	Not reported	Not reported	Not reported	Not reported
Grade 1 (CTCAE v 2.0)	1	Not reported	Not reported	Not reported	Not reported
Grade 2 (CTCAE v 2.0)	5	Not reported	Not reported	Not reported	Not reported
Grade 3 (CTCAE v 2.0)	2	Not reported	Not reported	Not reported	Not reported
Grade 4 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported
Grade 5 (CTCAE v 2.0)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
39
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
title
Leukopenia
categories
measurements
group Id
OG000
value
43
group Id
OG001
value
3
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
42
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
0
title
Neutropenia
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
8
group Id
OG002
value
10
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
title
Anemia
categories
measurements
group Id
OG000
value
41
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
4
group Id
OG004
value
0
group Id
OG005
value
0
title
Other hematologic
categories
measurements
group Id
OG000
value
45
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Allergy
categories
measurements
group Id
OG000
value
33
group Id
OG001
value
4
group Id
OG002
value
2
group Id
OG003
value
7
group Id
OG004
value
0
group Id
OG005
value
0
title
Hypertension
categories
measurements
group Id
OG000
value
41
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
4
group Id
OG004
value
1
group Id
OG005
value
0
title
Thrombosis Embolism
categories
measurements
group Id
OG000
value
34
group Id
OG001
value
8
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
title
Other cardiovascular
categories
measurements
group Id
OG000
value
43
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
Coagulation
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
16
group Id
OG002
value
6
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
0
title
Constitutional
categories
measurements
group Id
OG000
value
36
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Dermatologic

denoms

counts
group Id
OG000
value
46
group Id
OG001
value
46
group Id
OG002
value
46
group Id
OG003
value
46
group Id
OG004
value
46
group Id
OG005
value
46
units
Participants

description

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 Toxicity Criteria version 2.0
id
OG001
title
Grade 1 (CTCAE v 2.0)
description
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
id
OG002
title
Grade 2 (CTCAE v 2.0)
description
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
id
OG003
title
Grade 3 (CTCAE v 2.0)
description
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
id
OG004
title
Grade 4 (CTCAE v 2.0)
description
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
id
OG005
title
Grade 5 (CTCAE v 2.0)

param Type

COUNT_OF_PARTICIPANTS

population Description

Eligible and treated patients

reporting Status

POSTED

time Frame

Every cycle and 30 days after the end of treatment. (average 5 months)

title

Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice