Table 4.
Patient self reported acute toxic effects (grade 1–4) by menopausal status and treatment
| Toxicity | Premenopausal |
Postmenopausal |
||||
|---|---|---|---|---|---|---|
| Letrozole (N = 416) | Placebo (N = 416) | P | Letrozole (N = 2161) | Placebo (N = 2128) | P | |
| Edema | 20 | 19 | 0.57 | 22 | 21 | 0.40 |
| Hypertension | 2 | 5 | 0.06 | 6 | 5 | 0.44 |
| Hot flushes | 69 | 68 | 0.84 | 55 | 50 | 0.001 |
| Fatigue | 37 | 33 | 0.16 | 39 | 40 | 0.60 |
| Sweating | 40 | 35 | 0.14 | 28 | 28 | 0.77 |
| Anorexia | 3 | 2 | 0.65 | 6 | 5 | 0.05 |
| Constipation | 12 | 12 | 0.88 | 14 | 15 | 0.42 |
| Diarrhea | 5 | 5 | 0.68 | 7 | 7 | 0.75 |
| Nausea | 10 | 12 | 0.28 | 12 | 12 | 0.82 |
| Vaginal bleeding | 10 | 16 | 0.01 | 5 | 6 | 0.16 |
| Infection w/o neutropenia | 4 | 5 | 0.20 | 5 | 4 | 0.13 |
| Arthritis | 4 | 2 | 0.29 | 7 | 6 | 0.14 |
| High cholesterola | 16 | 13 | 0.27 | 16 | 16 | 0.86 |
| Dizziness | 14 | 16 | 0.62 | 18 | 17 | 0.36 |
| Insomnia | 8 | 6 | 0.23 | 6 | 5 | 0.12 |
| Depression | 7 | 6 | 0.50 | 5 | 5 | 0.56 |
| Headache | 31 | 31 | 0.94 | 27 | 25 | 0.36 |
| Arthralgia | 24 | 16 | 0.004 | 25 | 21 | 0.002 |
| Myalgia | 16 | 12 | 0.16 | 15 | 12 | 0.007 |
| Bone pain | 6 | 5 | 0.95 | 5 | 6 | 0.60 |
| Dyspnea | 3 | 5 | 0.17 | 7 | 7 | 0.72 |
| Alopecia | 5 | 5 | 0.90 | 5 | 3 | 0.003 |
| Vaginal dryness | 11 | 8 | 0.29 | 5 | 4 | 0.40 |
aChange from normal to high.
From chi-square test for the comparison in the incidence of toxicity between letrozole and placebo.