| Serious adverse event | Estradiol 6 mg/day (n = 34) | Estradiol 30 mg/day (n = 32) | ||
|---|---|---|---|---|
| n | % | n | % | |
| Nausea/vomiting | 0 | 0.0 | 5 | 15.6 |
| Hyponatremia | 1 | 2.9 | 5 | 15.6 |
| Pleural effusion | 0 | 0.0 | 4 | 12.5 |
| Pain | 6 | 17.6 | 4 | 12.5 |
| Thrombosis/embolism | 1 | 2.9 | 1 | 3.1 |
| Brain ischemia | 1 | 2.9 | 0 | 0.0 |
| Infection | 2 | 5.9 | 3 | 9.4 |
| Hypercalcemia | 0 | 0.0 | 2 | 6.3 |
| Other | 6 | 17.6 | 10 | 31.3 |
| Summary: Side effects in a small phase 2 study of women with metastatic breast cancer randomized to receive either 6 or 30 mg/day of oral estradiol as therapy. "The adverse event rate (≥grade 3) in the 30-mg group (11/32 [34%]; 95% confidence interval [CI], 23%-47%) was higher than in the 6-mg group (4/34 [18%]; 95% CI, 5%-22%; p=0.03). Clinical benefit rates were 9 of 32 (28%; 95% CI, 18%-41%) in the 30-mg group and 10 of 34 (29%; 95% CI, 19%-42%) in the 6-mg group." Sources: | ||||
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