Table 3.
Most commonly reported treatment‐related adverse events (AE) (≥2%),† whole safety population
| Number of patients (%)‡ | ||
|---|---|---|
| Anastrozole (n = 48) | Tamoxifen (n = 48)§ | |
| Hot flash | 8 (17) | 10 (21) |
| Aspartate aminotransferase increased | 2 (4) | 7 (15) |
| Alanine aminotransferase increased | 2 (4) | 6 (13) |
| Hepatic steatosis | 3 (6) | 4 (8) |
| Hyperhidrosis | 3 (6) | 4 (8) |
| Arthralgia | 3 (6) | 3 (6) |
| Genital discharge | 0 (0) | 5 (10) |
| Headache | 5 (10) | 0 (0) |
| Nausea | 2 (4) | 3 (6) |
| Alopecia | 0 (0) | 4 (8) |
| Back pain | 1 (2) | 3 (6) |
| Dizziness | 3 (6) | 1 (2) |
| Hypertension | 3 (6) | 1 (2) |
| Osteoporosis | 3 (6) | 1 (2) |
| Endometrial hypertrophy | 0 (0) | 3 (6) |
| Musculoskeletal stiffness | 3 (6) | 0 (0) |
†Considered by the investigator to be related to randomized drug treatment. AE categorized according to the National Cancer Institute Common Terminology Criteria Version 2.0 wherever possible. ‡Patients with multiple events in the same category are counted only once in that category. Patients with events in more than one category are counted once in each of those categories. §Includes 12 patients who switched from randomized tamoxifen to receive open‐label anastrozole.