NCT00112489 · OUTCOME
Nature and Degree of Toxicity
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer · Source last updated 2018-09-25
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 study treatment and up to 30 days after stopping study treatment
What was measured
Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
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 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
Grade 5 (CTCAE v.3.0)
Number of patients who experienced a grade 5 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 | 46 |
|---|
| Grade 1 (CTCAE v 3.0) | 46 |
|---|
| Grade 2 (CTCAE v 3.0) | 46 |
|---|
| Grade 3 (CTCAE v 3.0) | 46 |
|---|
| Grade 4 (CTCAE v 3.0) | 46 |
|---|
| Grade 5 (CTCAE v.3.0) | 46 |
|---|
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) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (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 | 1 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 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 3.0) | 19 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (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 | 4 | 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) | 27 | 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) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (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 | 43 | 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) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (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 | 40 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Auditory
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 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 |
|---|
| Grade 5 (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 | 39 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (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 | 45 | 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 |
|---|
| Grade 5 (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 | 33 | 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) | 4 | 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 |
|---|
| Grade 5 (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 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 3 (CTCAE v 3.0) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 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 | 8 | 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) | 31 | 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 |
|---|
| Grade 5 (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 | 36 | 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) | 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 |
|---|
| Grade 5 (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 | 44 | 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 |
|---|
| Grade 5 (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 | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 14 | 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 |
|---|
| Grade 5 (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 | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 2 (CTCAE v 3.0) | 8 | 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 |
|---|
| Grade 5 (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 | 35 | 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) | 3 | 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 |
|---|
| Grade 5 (CTCAE v.3.0) | 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 | 35 | 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) | 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 |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Stomatitis
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 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 |
|---|
| Grade 5 (CTCAE v.3.0) | 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 | 45 | 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 |
|---|
| Grade 5 (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 | 43 | 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) | 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 |
|---|
| Grade 5 (CTCAE v.3.0) | 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 | 45 | 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 |
|---|
| Grade 5 (CTCAE v.3.0) | 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 0 | 45 | 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 |
|---|
| Grade 5 (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 | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 1 (CTCAE v 3.0) | 18 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Creatinine
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 44 | 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 |
|---|
| Grade 5 (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 | 41 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Neurologic
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 3.0) | 0 | 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) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Neuromotor
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Grade 0 | 44 | 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 |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Sensory neuropathy
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) | 15 | 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) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Ocular/visual
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 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) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 4 (CTCAE v 3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (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 | 35 | 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) | 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) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Grade 5 (CTCAE v.3.0) | 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 | 35 | 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) | 7 | 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 |
|---|
| Grade 5 (CTCAE v.3.0) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Arthralgia
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 3.0) | 4 | 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 |
|---|
| Grade 5 (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 | 37 | 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) | 2 | 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 |
|---|
| Grade 5 (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
- 4
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Leukopenia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 20
- group Id
- OG005
- value
- 0
- title
- Neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- title
- Thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Other hematologic
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Allergy
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Auditory
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Cardiovascular
- categories
- measurements
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Coagulation
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Constitutional
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Alopecia
- 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
- Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
- 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)
- description
- Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
- id
- OG005
- title
- Grade 5 (CTCAE v.3.0)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible and Evaluable patients
- reporting Status
- POSTED
- time Frame
- During study treatment and up to 30 days after stopping study treatment
- title
- Nature and Degree of Toxicity
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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