Summary of reportable events
| Patients, n (%) | Full analysis set (N=149) |
| SAE | 13 (9) |
| AESI | 1 (0.7) |
| Any product complaints | 2 (1) |
| System organ class | |
| Infections* | 4 (2.7) |
| Eye disorders† | 3 (2) |
| Pregnancy, puerperium, and perinatal conditions | 3 (2) |
*One event each of appendicitis, atypical pneumonia, meningitis, orchitis, sepsis, and urinary tract infection.
†One event each of eye inflammation and ocular hypertension and two events of glaucoma.
AESI, adverse event of special interest; SAE, serious adverse event.