Table 5.

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 = 2,563Placebo, n = 2,573Letrozole, n = 2,563Placebo, n = 2,573
Any adverse event2,232 (87.1)2,174 (84.5)419 (16.3)389 (15.1)
Vascular disorders1,375 (53.6)1,230 (47.8)59 (2.3)74 (2.9)
    Flushing1,273 (49.7)1,114 (43.3)3 (0.1)0
General disorders1,154 (45.0)1,090 (42.4)30 (1.2)28 (1.1)
    Asthenia862 (33.6)826 (32.1)16 (0.6)7 (0.3)
Musculoskeletal disorders978 (38.2)836 (32.5)71 (2.8)50 (1.9)
    Arthralgia565 (22.0)465 (18.1)25 (1.0)20 (0.8)
Nervous system disorders863 (33.7)819 (31.8)65 (2.5)58 (2.3)
    Headache516 (20.1)508 (19.7)18 (0.7)17 (0.7)
    Dizziness363 (14.2)342 (13.3)9 (0.4)6 (0.2)
Skin disorders830 (32.4)787 (30.6)17 (0.7)16 (0.6)
    Sweating increased619 (24.2)577 (22.4)1 (<0.1)0
Gastrointestinal disorders725 (28.3)731 (28.4)43 (1.7)42 (1.6)
    Constipation290 (11.3)304 (11.8)6 (0.2)2 (<0.1)
    Nausea221 (8.6)212 (8.2)3 (0.1)10 (0.4)
    Diarrhea not otherwise specific128 (5.0)143 (5.6)12 (0.5)8 (0.3)
Metabolic disorders551 (21.5)537 (20.9)24 (0.9)32 (1.2)
    Hypercholesterolaemia401 (15.6)398 (15.5)2 (<0.1)5 (0.2)
  • NOTE: The reported adverse events were observed after the first month of treatment.