NCT00075400 · OUTCOME
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer · 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
- Each cycle during treatment and 30 days after treatment ends.
What was measured
The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
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 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
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 3.0) | 23 |
|---|
| Grade 2 (CTCAE v 3.0) | 23 |
|---|
| Grade 3 (CTCAE v 3.0) | 23 |
|---|
| Grade 4 (CTCAE v 3.0) | 23 |
|---|
Reported measurements
Leukopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Hearing
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 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cardiovascular
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 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Endocrine
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Genitourinary
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 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphatics
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 3.0) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Metabolic
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 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Neuropathy
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Ocular
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Sexual
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 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Leukopenia
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Allergy
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Hearing
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Cardiovascular
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- Constitutional
- 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
- title
- Dermatologic
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Endocrine
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- Gastrointestinal
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- Genitourinary
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Hemorrhage
- 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
- units
- Participants
- description
- The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
- 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 3.0
- id
- OG001
- title
- Grade 1 (CTCAE v 3.0)
- description
- Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
- id
- OG002
- title
- Grade 2 (CTCAE v 3.0)
- description
- Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
- id
- OG003
- title
- Grade 3 (CTCAE v 3.0)
- description
- Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
- id
- OG004
- title
- Grade 4 (CTCAE v 3.0)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible and treated patients
- reporting Status
- POSTED
- time Frame
- Each cycle during treatment and 30 days after treatment ends.
- title
- Incidence of Adverse Effects as Assessed by CTCAE v 3.0
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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