AEs in 10 Completed DaTscan Clinical Trials
| All | Related | |||
| AE | n | % | n | % |
| No. of AEs | 643 | 76 | ||
| No. of subjects with any AE | 261 | 22 | 42 | 4 |
| AEs by maximum intensity | ||||
| Mild | 124 | 11 | 26 | 2 |
| Moderate | 94 | 8 | 15 | 1 |
| Severe | 39 | 3 | 1 | <1 |
| AEs in ≥ 1% of all subjects | ||||
| Headache | 42 | 4 | 14 | 1 |
| Nausea | 21 | 2 | 8 | <1 |
| Dizziness | 21 | 2 | 3 | <1 |
| Nasopharyngitis | 16 | 1 | 0 | 0 |
| Injection site hematoma | 12 | 1 | 3 | <1 |
| No. of subjects with any SAE | 44 | 4 | 0 | 0 |
| SAEs in > 1 subject | ||||
| Chest pain | 3 | <1 | 0 | 0 |
| Fall | 3 | <1 | 0 | 0 |
| Femoral neck fracture | 3 | <1 | 0 | 0 |
| Abdominal pain | 2 | <1 | 0 | 0 |
| Pneumonia | 2 | <1 | 0 | 0 |
| Joint dislocation | 2 | <1 | 0 | 0 |
| Dementia | 2 | <1 | 0 | 0 |
SAE = serious AE.
n = 1,180 subjects.