Table 3.
Adverse Events.*
| Event | Letrozole (N = 959) | Placebo (N = 954) | P Value |
|---|---|---|---|
| number (percent) | |||
|
Toxic effect during receipt of trial regimen
| |||
| Edema | 158 (16) | 136 (14) | 0.19 |
|
| |||
| Hypertension | 157 (16) | 145 (15) | 0.48 |
|
| |||
| Hot flashes | 360 (38) | 354 (37) | 0.84 |
|
| |||
| Fatigue | 346 (36) | 355 (37) | 0.61 |
|
| |||
| Constipation | 117 (12) | 140 (15) | 0.10 |
|
| |||
| Diarrhea | 105 (11) | 81 (8) | 0.07 |
|
| |||
| Arthritis | 317 (33) | 288 (30) | 0.18 |
|
| |||
| Hypercholesterolemia | 203 (21) | 184 (19) | 0.31 |
|
| |||
| Dizziness | 145 (15) | 139 (15) | 0.74 |
|
| |||
| Headache | 151 (16) | 138 (14) | 0.43 |
|
| |||
| Insomnia | 269 (28) | 243 (25) | 0.20 |
|
| |||
| Arthralgia | 513 (53) | 475 (50) | 0.10 |
|
| |||
| Myalgia | 268 (28) | 240 (25) | 0.31 |
|
| |||
| Bone pain | 174 (18) | 133 (14) | 0.01 |
|
| |||
| Dyspnea | 148 (15) | 165 (17) | 0.27 |
|
| |||
| Vaginal dryness | 102 (11) | 96 (10) | 0.68 |
|
| |||
| Elevated alkaline phosphatase level — no./total no. (%)† | 111/928 (12) | 78/916 (9) | 0.01 |
|
| |||
| Elevated aspartate aminotransferase level — no./total no. (%)† | 133/928 (14) | 131/915 (14) | 0.92 |
|
| |||
| Elevated alanine aminotransferase level — no./total no. (%)† | 97/909 (11) | 128/894 (14) | 0.02 |
|
| |||
| Bone fracture‡ | 133 (14) | 88 (9) | 0.001 |
|
| |||
| Spine | 17 (2) | 9 (1) | 0.12 |
|
| |||
| Wrist | 27 (3) | 16 (2) | 0.09 |
|
| |||
| Pelvis | 1 (<1) | 7 (1) | 0.08 |
|
| |||
| Hip | 7 (1) | 6 (1) | 0.79 |
|
| |||
| Femur | 9 (1) | 4 (<1) | 0.17 |
|
| |||
| Tibia | 5 (1) | 4 (<1) | 0.74 |
|
| |||
| Ankle | 19 (2) | 11 (1) | 0.14 |
|
| |||
| Other | 68 (7) | 48 (5) | 0.06 |
|
| |||
| New-onset osteoporosis | 109 (11) | 54 (6) | <0.001 |
|
| |||
| Cardiovascular event | 116 (12) | 98 (10) | 0.21 |
|
| |||
|
Toxic effect after discontinuation of trial regimen
| |||
| Hot flashes | 25 (3) | 17 (2) | 0.22 |
|
| |||
| Arthralgia | 22 (2) | 24 (3) | 0.75 |
|
| |||
| Hypertension | 8 (1) | 4 (<1) | 0.25 |
|
| |||
| Superventricular arrhythmia | 6 (1) | 3 (<1) | 0.32 |
|
| |||
| Bone fracture‡ | 54 (6) | 57 (6) | 0.75 |
|
| |||
| Spine | 13 (1) | 9 (1) | 0.40 |
|
| |||
| Wrist | 4 (<1) | 4 (<1) | 1 |
|
| |||
| Pelvis | 3 (<1) | 4 (<1) | 0.70 |
|
| |||
| Hip | 5 (1) | 0 | 0.07 |
|
| |||
| Femur | 2 (<1) | 7 (1) | 0.09 |
|
| |||
| Tibia | 3 (<1) | 2 (<1) | 0.65 |
|
| |||
| Ankle | 3 (<1) | 6 (1) | 0.31 |
|
| |||
| Other | 32 (3) | 31 (3.2) | 0.92 |
|
| |||
| New-onset osteoporosis | 20 (2) | 11 (1.2) | 0.11 |
*
With the exception of bone toxic effects, for which all adverse events are listed independently of incidence, the data shown refer to adverse events of at least grade 1 for which the incidence in the two groups differed by more than 1% or for which the incidence was at least 10% in either group. Grades were assigned in accordance with the National Cancer Institute Common Toxicity Criteria, version 2.0.
†
The denominator for these laboratory abnormalities is for the number of women for whom the laboratory evaluation was performed. These evaluations were required only during protocol therapy.
‡
Each patient may have had more than one fracture.