Table 5

Annual incidence rates of serious and non-serious ocular drug-related AEs and ocular AEs of special interest using a 30 day risk period (Treated eyes of safety patients*)

Incidence rateNumber of eventsTreated eye-time-at risk, yearsValue95% CI
Lower limitUpper limit
Drug-related AEs
 Serious, overall1435.19780.002300.0068
 Non-serious, overall9435.19780.02070.00720.0342
AEs of special interest
 Serious, overall1435.19780.002300.0068
 Non-serious, overall4435.19780.00920.00020.0182
  • Lower limits less than 0 were set 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.

  • AE, adverse event.