Table 2.
Overall Summary of AEs
| Bazedoxifene | Raloxifene | Placebo | ||
|---|---|---|---|---|
| Subjects, n (%) | 20 mg (n = 1886) |
40 mg (n = 1872) |
60 mg (n = 1849) |
(n = 1885) |
| Any AE | 1807 (95.8) | 1792 (95.7) | 1777 (96.1) | 1814 (96.2) |
| Any serious AE | 382 (20.3) | 368 (19.7) | 344 (18.6) | 354 (18.8) |
| Discontinuations due to AE | 278 (14.7) | 280 (15.0) | 273 (14.8) | 253 (13.4) |
| AEs > 10% in any treatment group | ||||
| Back pain | 607 (32.2) | 591 (31.6) | 602 (32.6) | 616 (32.7) |
| Arthralgia | 594 (31.5) | 574 (30.7) | 601 (32.5) | 580 (30.8) |
| Pain | 568 (30.1) | 559 (29.9) | 588 (31.8) | 592 (31.4) |
| Flu syndrome | 489 (25.9) | 481 (25.7) | 512 (27.7) | 509 (27.0) |
| Infection | 462 (24.5) | 433 (23.1) | 439 (23.7) | 452 (24.0) |
| Abdominal pain | 409 (21.7) | 413 (22.1) | 448 (24.2) | 456 (24.2) |
| Accidental injurya | 449 (23.8) | 394 (21.0) | 387 (20.9) | 468 (24.8) |
| Headache | 432 (22.9) | 446 (23.8) | 417 (22.6) | 443 (23.5) |
| Hypertension | 396 (21.0) | 379 (20.2) | 375 (20.3) | 394 (20.9) |
| Constipation | 352 (18.7) | 356 (19.0) | 340 (18.4) | 327 (17.3) |
| Hot flushesb | 238 (12.6) | 244 (13.0) | 223 (12.1) | 119 (6.3) |
| Cough increased | 216 (11.5) | 192 (10.3) | 178 (9.6) | 199 (10.6) |
| Leg crampsa | 207 (11.0) | 205 (11.0) | 221 (12.0) | 156 (8.3) |
| Asthenia | 209 (11.1) | 198 (10.6) | 212 (11.5) | 202 (10.7) |
| Dyspepsia | 192 (10.2) | 169 (9.0) | 178 (9.6) | 195 (10.3) |
| Peripheral edema | 200 (10.6) | 184 (9.8) | 194 (10.5) | 166 (8.8) |
| Urinary tract infection | 183 (9.7) | 176 (9.4) | 197 (10.7) | 170 (9.0) |
| Dizziness | 193 (10.2) | 171 (9.1) | 165 (8.9) | 187 (9.9) |
| Diarrheac | 165 (8.7) | 209 (11.2) | 211 (11.4) | 182 (9.7) |
AE, adverse event.
aP < 0.01; Chi-square test.
bP < 0.001; Chi-square test.
cP < 0.05; Chi-square test.