DIASAFE adverse event overview
| Body system | N=226 Total number of events (number of patients) |
|---|---|
| Respiratory, thoracic and mediastinal disorders | 53 (45) |
| Nervous system disorders | 15 (11) |
| Dysgeusia | 5 |
| Dizziness | 4 |
| Somnolence | 3 |
| Paraesthesia mucosal | 2 |
| Depressed level of consciousness | 1 |
| Gastrointestinal disorders | 11 (9) |
| General disorders and administration site conditions | 3 (3) |
| Skin and subcutaneous tissue disorders | 2 (2) |
| Psychiatric disorders | 1 (1) |
| Anxiety | 1 |
| Eye disorders | 1 (1) |
| Vascular disorders | 1 (1) |
| Injury, poisoning and procedural complications | |
| Total number of events (number of patients) | 87 Total |
| 10 Non-related* 77 Related† 81 Mild 5 Moderate 0 Severe 1 Unknown severity |
*Non-related events are defined as Unlikely or Unrelated to study medication.
†Related events are defined as Definite, Probably or Possibly related to study medication.
N, the number of patients in the population.