Table 2.
Grade 3, 4 or 5 Toxicities Possibly or Probably Related to Treatment During and After Course 1*
| Course 1 | After Course 1 | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Level | Dose Level | |||||||||||||||
| Adverse Event† | 1 (n = 3) | 2 (n = 4) | 5 (n = 6) | 6 (n = 6) | 1 (n = 3) | 2 (n = 4) | 5 (n = 5) | 6 (n = 2) | ||||||||
| Grade | Grade | Grade | Grade | Grade | Grade | Grade | Grade | |||||||||
| 3 | 3 | 4 | 3 | 4 | 3 | 4 | 3 | 4 | 3 | 4 | 5 | 3 | 4 | 3 | 4 | |
| Elevated lipase | 1 | |||||||||||||||
| Hypophosphatemia | 2 | 1 | ||||||||||||||
| Hypokalemia | 1 | |||||||||||||||
| Hyponatremia | 1 | |||||||||||||||
| Anorexia | 1 | |||||||||||||||
| Weight loss | 1 | |||||||||||||||
| Vomiting | 1 | |||||||||||||||
| Hand-foot syndrome | 1 | 1 | 1 | 1 | 2 | |||||||||||
| Pneumothorax | 1 | |||||||||||||||
| Decreased leukocytes (total) | 1 | 2 | 2 | 1 | 1 | |||||||||||
| Lymphopenia | 1 | 1 | 2 | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | |||||
| Neutropenia | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 2 | 1 | 1 | |||||
| Anemia | 1 | 2 | 1 | |||||||||||||
| Thrombocytopenia | 1 | |||||||||||||||
| Thrombosis | 1 | |||||||||||||||
| Febrile neutropenia | 1 | 1 | ||||||||||||||
| Infection with neutropenia | 1 | |||||||||||||||
| Bladder | 1 | |||||||||||||||
*
Grades are according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
†
Each adverse event was counted once (any course, highest grade) for each patient.