Table 2.
Treatment-Related Adverse Events*
| AZD6244 bid Dose (No. of patients) | Total No. of Patients (N = 57) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 50 mg (n = 3) | 100 mg (n = 31) | 200 mg (n = 15) | 300 mg (n = 8) | ||||||||||
| Adverse Event | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | |||||
| Any event | 3 | 30 | 14 | 7 | 54 | ||||||||
| Rash† | 2 | 0 | 21 | 3 | 8 | 4 | 3 | 2 | 43 | ||||
| Diarrhea | 2 | 0 | 16 | 0 | 12 | 0 | 2 | 1 | 33 | ||||
| Nausea | 0 | 0 | 13 | 1 | 8 | 0 | 3 | 0 | 25 | ||||
| Fatigue | 2 | 0 | 8 | 1 | 8 | 1 | 2 | 0 | 22 | ||||
| Peripheral edema | 1 | 0 | 9 | 1 | 6 | 0 | 2 | 0 | 19 | ||||
| Vomiting | 0 | 0 | 7 | 0 | 5 | 0 | 2 | 0 | 14 | ||||
| ALT elevation | 0 | 1 | 4 | 0 | 4 | 0 | 0 | 0 | 9 | ||||
| AST elevation | 1 | 0 | 2 | 1 | 5 | 0 | 0 | 0 | 9 | ||||
| Blurred vision | 0 | 0 | 2 | 0 | 2 | 0 | 3 | 0 | 7 | ||||
*
Data include treatment-related adverse events with an onset date on or after the day 1 single dose in part A or the first dose in Part B.
†
Rash includes the following Medical Dictionary for Regulatory Activities preferred terms: Dermatitis Acneiform, Rash, Rash Erythematous, Rash Maculo-papular, and Rash Pruritic.