Adverse events (AEs) per treatment (safety analysis set, N=148)*
| Verum (n=73) | Placebo (n=75) | |||
| Events | Patients (%) | Events | Patients (%) | |
| AE | 41 | 18 (24.7) | 50 | 21 (28.0) |
| Related AE† | 1 | 1 (1.4) | 7 | 2 (2.7) |
| Serious AE | 1 | 1 (1.4)‡ | 0 | 0 |
| Mild AE§ | 32 | 11 (15.1) | 38 | 19 (25.3) |
| Moderate AE¶ | 8 | 7 (9.6) | 12 | 7 (9.3) |
| Severe AE** | 1 | 1 (1.4) | 0 | 0 |
| Most frequent AEs†† | ||||
| Headache | 17 | 7 (4.7) | 13 | 7 (4.7) |
| Back pain | 0 | 0 | 10 | 6 (4.1) |
| Nasopharyngitis | 0 | 0 | 10 | 6 (4.1) |
*The safety analysis set includes all randomised patients who received the study drug at least once.
†At least reasonable possibility of causal relationship to study drug.
‡The patient was admitted to hospital due to ‘chest pain’, AE was severe but not related to the study drug.
§Mild: normal functional level not impaired or only slightly impaired.
¶Moderate: normal functional level to a certain extent impaired.
**Severe: normal functional level markedly impaired.
††Events in at least four study participants overall, all not related.