Table 3.
Select Adverse Events Reported As Definitely, Probably, or Possibly Related to Treatment and Occurring at Any Time (N = 82)
| Adverse Event Category | Event Grade |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2 |
3 |
4 |
5 |
|||||
| No. | % | No. | % | No. | % | No. | % | |
| Blood/bone marrow | 15 | 18 | 29 | 35 | 8 | 10 | 0 | 0 |
| Hemoglobin | 14 | 17 | 6 | 7 | 0 | 0 | 0 | 0 |
| Leukopenia NOS | 18 | 22 | 24 | 29 | 1 | 1 | 0 | 0 |
| Lymphopenia | 2 | 2 | 5 | 6 | 3 | 4 | 0 | 0 |
| Neutrophil count | 17 | 21 | 15 | 18 | 5 | 6 | 0 | 0 |
| Platelet count | 16 | 20 | 10 | 12 | 0 | 0 | 0 | 0 |
| Cardiac, general | 4 | 5 | 3 | 4 | 0 | 0 | 0 | 0 |
| Constitutional symptom | 29 | 35 | 22 | 27 | 0 | 0 | 0 | 0 |
| Death not associated with CTCAE 3.0 toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Dermatologic/skin | 2 | — | 2 | — | 0 | 0 | 0 | 0 |
| Gastrointestinal | 33 | 40 | 26 | 32 | 2 | 2 | 1 | 1 |
| Hemorrhage/bleeding | 3 | 4 | 4 | 5 | 1 | 1 | 0 | 0 |
| Infection | 3 | 4 | 2 | 2 | 1 | 1 | 1 | 1 |
| Musculoskeletal/soft tissue | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 |
| Neurologic | 4 | 5 | 2 | 2 | 0 | 0 | 0 | 0 |
| Ocular/visual | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Pain | 16 | 20 | 5 | 6 | 2 | 2 | 0 | 0 |
| Pulmonary/upper respiratory | 5 | 6 | 4 | 5 | 0 | 0 | 0 | 0 |
| Syndrome | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Vascular | 0 | 0 | 1 | 1 | 2 | 2 | 0 | 0 |
Abbreviations: NOS, not otherwise specified; CTCAE 3.0, Common Terminology Criteria of Adverse Events, version 3.0.