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Incidence of adverse events
| Variable | Patients (n = 11,321) |
|---|---|
| Any AE, n (%) | 164 (1.4) |
| Any SAE, n (%) | 3 (<0.1) |
| AE related to treatment, n (%) | 64 (0.6) |
| SAE related to treatment, n (%) | 0 (0.0) |
| Discontinuations due to AEs, n (%) | 22 (0.2) |
| Most frequent AEs, n (%) | |
| Dizziness | 27 (0.2) |
| Headache | 25 (0.2) |
| Edema | 19 (0.2) |
| Upper respiratory tract infection | 18 (0.2) |
| Cough | 9 (0.1) |
AE adverse event, SAE serious adverse event
