Safety analyses in the ERADIAS trial
| No (%) of patients having: | Placebo (n=209) | ASU-E (n=189) | Total (n=398) |
|---|---|---|---|
| At least one AE (p=0.30) | 178 (85.2) | 168 (88.9) | 346 (86.9) |
| At least one AE of | |||
| ‘Moderate to severe’ intensity and unknown intensity | 160 (76.6) | 146 (77.3) | 306 (76.9) |
| ‘Mild’ intensity | 119 (56.9) | 110 (58.2) | 229 (57.5) |
| No of patients with at least one treatment related* AE | 13 (6.2) | 19 (10.1) | 32 (8.0) |
| No of treatment related* AE | 20 (2.1) | 28 (3.4) | 48 (2.7) |
| At least one AE leading to treatment cessation | 31 (14.8)† | 32 (16.9)† | 63 (15.8)† |
| At least one serious AE (P=0.14) | 68 (32.5)‡ | 75 (39.7)‡ | 143 (35.9)‡ |
| At least one serious treatment related AE | 2 (1.0) | 4 (2.1) | 6 (1.5) |
| 1 hip replacement | 3 hip replacements | ||
| 1 wrist fracture | 1 post surgery haematoma | ||
| Deceased during the trial for treatment unrelated reasons | 1 glioblastoma 1 heart attack (ventricular tachycardia) | 1 myocardial infarction with operated interventricular communication | 3 |
*Related=missing, doubtful, probable, possible, highly possible.
†18 patients in the placebo group and 16 patients in the ASU-E group withdrew from the trial for hip arthroplasty after treatment discontinuation.
‡33 patients in the placebo group and 29 patients in the ASU-E group had a hip arthroplasty after treatment discontinuation.
AE, adverse event; ASU-E, avocado–soybean unsaponifiable—Expanscience.