Annual incidence rates of serious and non-serious systemic drug-related AEs and AEs of special interest (Safety set*)
| Incidence rate | 15-day risk period | 30-day risk period | ||||
| Number of events | Patient-time-at risk, years | Value (95% CI) | Number of events | Patient-time-at risk, years | Value (95% CI) | |
| Drug-related AEs | ||||||
| Serious | ||||||
| Overall | 2 | 224.1424 | 0.0089 (0 to 0.0213) | 3 | 415.1732 | 0.0071 (0 to 0.0154) |
| Unilaterally | 2 | 181.0212 | 0.0110 (0 to 0.0264) | 3 | 352.5695 | 0.0085 (0 to 0.0181) |
| Bilaterally | 0 | 43.1211 | 0 (0 to 0) | 0 | 62.6037 | 0 (0 to 0) |
| Non-serious | None | |||||
| AEs of special interest | ||||||
| Serious | ||||||
| Overall | 3 | 224.1424 | 0.0134 (0 to 0.0285) | 5 | 415.1732 | 0.0120 (0.0015 to 0.0226) |
| Unilaterally | 3 | 181.0212 | 0.0166 (0 to 0.0353) | 5 | 352.5695 | 0.0142 (0.0018 to 0.0266) |
| Bilaterally | 0 | 43.1211 | 0 (0 to 0) | 0 | 62.6037 | 0 (0 to 0) |
| Non-serious | ||||||
| Overall | 1 | 224.1424 | 0.0045 (0 to 0.0132) | 2 | 415.1732 | 0.0048 (0 to 0.0115) |
| Unilaterally | 1 | 181.0212 | 0.0055 (0 to 0.0164) | 2 | 352.5695 | 0.0057 (0 to 0.0135) |
| Bilaterally | 0 | 43.1211 | 0 (0 to 0) | 0 | 62.6037 | 0 (0 to 0) |
*Consisted of all enrolled patients who signed the informed consent, received at least one dose of study drug and had at least one postbaseline safety assessment. Lower limits less than 0 were set to 0.
AE, adverse event.