NCT00379145 · OUTCOME
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus · Source last updated 2017-12-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
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 for Adverse Events v3.0 (CTCAE).
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
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 | 20 |
|---|
| Grade 1 (CTCAE v 3.0) | 20 |
|---|
| Grade 2 (CTCAE v 3.0) | 20 |
|---|
| Grade 3 (CTCAE v 3.0) | 20 |
|---|
| Grade 4 (CTCAE v 3.0) | 20 |
|---|
Reported measurements
Leukopenia
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 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Thrombocytopenia
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 3.0) | 4 | 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) | 3 | 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 | 2 | 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) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Anemia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 10 | 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 |
|---|
Other hematologic
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) | 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 |
|---|
Coagulation
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) | 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 |
|---|
Hemorrhage
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) | 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 |
|---|
Nausea
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 11 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 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 | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 3 | 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 |
|---|
Bilirubin
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) | 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 |
|---|
ALT
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Alkaline Phosphatase
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) | 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 |
|---|
Dermatologic
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 4 | 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 |
|---|
Infection
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) | 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) | 1 | 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 | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 4 | 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 |
|---|
Metabolic
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 3.0) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 3 | 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 | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 4 | 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 |
|---|
Pain
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 3.0) | 10 | 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 |
|---|
Constitutional
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) | 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 |
|---|
Fatigue
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) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 7 | 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 |
|---|
Musculoskeletal
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 3.0) | 4 | 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 |
|---|
Neurotoxicity
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 3.0) | 4 | 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 |
|---|
Peripheral neuropathy
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) | 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 |
|---|
Renal
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) | 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 |
|---|
Ocular
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 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 |
|---|
Vascular
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) | 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 |
|---|
Flu-like syndrome
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) | 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 |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 1
- title
- Leukopenia
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- title
- Thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 5
- title
- Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Other hematologic
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Coagulation
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Hemorrhage
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Nausea
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Vomiting
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Bilirubin
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- title
- ALT
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Alkaline Phosphatase
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 20
- 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 for Adverse Events v3.0 (CTCAE).
- id
- OG001
- title
- Grade 1 (CTCAE v 3.0)
- description
- Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
- id
- OG002
- title
- Grade 2 (CTCAE v 3.0)
- description
- Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
- id
- OG003
- title
- Grade 3 (CTCAE v 3.0)
- description
- Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
- id
- OG004
- title
- Grade 4 (CTCAE v 3.0)
- param Type
- NUMBER
- population Description
- Eligible and treated patients
- reporting Status
- POSTED
- time Frame
- Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
- title
- Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle