Table 4.
Number of Adverse Events (≥ Grade 2) attributed to therapy and observed in more than 10% of evaluable patients in at least 1 stratum in the Phase II study
| Number of Episodes for Each Toxicity (Within a patient, the highest grade is reported for each episode) Toxicity |
Stratum A | Stratum B | Stratum C | |||||
|---|---|---|---|---|---|---|---|---|
| Grade | Grade | Grade | ||||||
| 2 | 3 | 4 | 2 | 3 | 2 | 3 | 4 | |
| Diarrhea | 6 | 3 | 1 | 3 | 2 | . | ||
| Fatigue (lethargy, malaise, asthenia) | 1 | 2 | 3 | |||||
| Rash/desquamation | 1 | 1 | 1 | 2 | ||||
| Vomiting | 3 | |||||||
| Dehydration | 2 | 1 | ||||||
| Lymphopenia | 3 | 1 | 1 | 2 | 2 | 1 | ||
| ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | 1 | ||||||
| hypokalemia | 1 | 2 | 1 | |||||
| hypophosphatemia | 2 | 1 | 1 | 1 | ||||
| hyperbilirubinemia | 2 | 1 | ||||||
| hypoalbuminemia | 1 | 2 | 1 | |||||
| hyponatremia | 2 | |||||||