Table 4:
Grade 2 or Higher Adverse Eventsa Occurring in >5% of Patients (N=49)
| Grade 2 | Grade 3 | Grade 4 | Total | |
|---|---|---|---|---|
| Diarrhea | 9 (18%) | 7 (14%) | 0 | 16 (33%) |
| Fatigue | 12 (25%) | 2 (4%) | 0 | 14 (29%) |
| Nausea | 8 (16%) | 5 (10%) | 0 | 13 (27%) |
| Anorexia | 9 (18%) | 1 (2%) | 0 | 10 (20%) |
| Alopecia | 9 (18%) | 0 | 0 | 9 (18%) |
| Neutrophil count decreased | 2 (4%) | 3 (6%) | 2 (4%) | 7 (14%) |
| Anemia | 5 (10%) | 0 | 0 | 5 (10%) |
| White blood cell decreased | 3 (6%) | 1 (2%) | 1 (2%) | 5 (10%) |
| Vomiting | 4 (8%) | 1 (2%) | 0 | 5 (10%) |
| Constipation | 3 (6%) | 1 (2%) | 0 | 4 (8%) |
| Abdominal pain | 1 (2%) | 2 (4%) | 0 | 3 (6%) |
| Alkaline phosphatase increased | 2 (4%) | 1 (2%) | 0 | 3 (6%) |
| Dysgeusia | 3 (6%) | 0 | 0 | 3 (6%) |
| Infusion related reaction | 3 (6%) | 0 | 0 | 3 (6%) |
| Platelet count decreased | 3 (6%) | 0 | 0 | 3 (6%) |
a
According to NCI-CTCAE v. 4.0
a
AEs attribution was definitely, probable, possible, or unknown/blank to study drug. AEs where attribution was not related or unlikely were not included.