Table 7.
Serious adverse events (SAS).
| MedDRA version 24.0 | |||
|---|---|---|---|
| System organ class (SOC), Preferred term (PT) | (N = 23) |
||
| n | (%) | Number of events | |
| Any adverse event | 5 | (21.74) | 5 |
| Infections and infestations | 3 | (13.04) | 3 |
| Bronchitis | 1 | (4.35) | 1 |
| Otitis media acute | 1 | (4.35) | 1 |
| Pneumonia bacterial | 1 | (4.35) | 1 |
| Respiratory, thoracic and mediastinal disorders | 1 | (4.35) | 1 |
| Chronic respiratory failure | 1 | (4.35) | 1 |
| Nervous system disorders | 1 | (4.35) | 1 |
| Seizure | 1 | (4.35) | 1 |
SAS, safety analysis set; MedDRA, medical dictionary for regulatory activities.