Table 4 Summary of serious adverse events (safety population)
Subject | Age | Sex | Study group | Event | Sx. onset (after study initiation) | Relationship to study drug | Seriousness | Dropout |
|---|---|---|---|---|---|---|---|---|
1 | 78 | F | Group 1 | Acute cerebral infarct | 41 days | Not related | Severe | no |
2 | 78 | M | Group 1 | Diabetic foot | 27 days | Not related | Moderate | no |
3 | 76 | M | Group 1 | 1st seizure (post-stroke) | 2 days | Not related | Moderate | yes |
4 | 85 | F | Group 2 | Fall | 47 days | Not related | Mild | yes |
5 | 68 | M | Group 2 | Unruptured cerebral aneurysm | 25 days | Not related | Mild | no |
6 | 76 | F | Group 2 | Dizziness, facial bone fx. | 11 days | Probably related | Moderate | yes |
7 | 78 | M | Group 2 | Inguinal hernia | 2 days | Not related | Moderate | no |
8 | 56 | F | Group 3 | Lumber sprain | 40 days | Not related | Mild | no |
9 | 77 | F | Group 3 | Influenza A, APN, gastroenteritis | 47 days | Not related | Moderate | no |
10 | 81 | F | Group 3 | Femur fx. after slip down | 14 days | Not related | Moderate | no |
11 | 78 | F | Group 3 | Nausea, vomiting, chilling | 0 day | Possibly related | Severe | yes |