The most frequently reported adverse events during chronic therapy
| Number (%) of patients with grade 1-4 adverse event | Number (%) of patients with grade 3-4 adverse event | |||||
|---|---|---|---|---|---|---|
| Letrozole, n = 2,563 | Placebo, n = 2,573 | Letrozole, n = 2,563 | Placebo, n = 2,573 | |||
| Any adverse event | 2,232 (87.1) | 2,174 (84.5) | 419 (16.3) | 389 (15.1) | ||
| Vascular disorders | 1,375 (53.6) | 1,230 (47.8) | 59 (2.3) | 74 (2.9) | ||
| Flushing | 1,273 (49.7) | 1,114 (43.3) | 3 (0.1) | 0 | ||
| General disorders | 1,154 (45.0) | 1,090 (42.4) | 30 (1.2) | 28 (1.1) | ||
| Asthenia | 862 (33.6) | 826 (32.1) | 16 (0.6) | 7 (0.3) | ||
| Musculoskeletal disorders | 978 (38.2) | 836 (32.5) | 71 (2.8) | 50 (1.9) | ||
| Arthralgia | 565 (22.0) | 465 (18.1) | 25 (1.0) | 20 (0.8) | ||
| Nervous system disorders | 863 (33.7) | 819 (31.8) | 65 (2.5) | 58 (2.3) | ||
| Headache | 516 (20.1) | 508 (19.7) | 18 (0.7) | 17 (0.7) | ||
| Dizziness | 363 (14.2) | 342 (13.3) | 9 (0.4) | 6 (0.2) | ||
| Skin disorders | 830 (32.4) | 787 (30.6) | 17 (0.7) | 16 (0.6) | ||
| Sweating increased | 619 (24.2) | 577 (22.4) | 1 (<0.1) | 0 | ||
| Gastrointestinal disorders | 725 (28.3) | 731 (28.4) | 43 (1.7) | 42 (1.6) | ||
| Constipation | 290 (11.3) | 304 (11.8) | 6 (0.2) | 2 (<0.1) | ||
| Nausea | 221 (8.6) | 212 (8.2) | 3 (0.1) | 10 (0.4) | ||
| Diarrhea not otherwise specific | 128 (5.0) | 143 (5.6) | 12 (0.5) | 8 (0.3) | ||
| Metabolic disorders | 551 (21.5) | 537 (20.9) | 24 (0.9) | 32 (1.2) | ||
| Hypercholesterolaemia | 401 (15.6) | 398 (15.5) | 2 (<0.1) | 5 (0.2) | ||
NOTE: The reported adverse events were observed after the first month of treatment.