Table 5 Ocular Adverse Events and Serious Adverse Events
FAS(N = 100) | |
|---|---|
Patients who had an Adverse Event, n (%)a | 8 (8) |
Total no. of Adverse Event, E | 13 |
Total no. of TEAEs | 12 |
Severity, n (%) b | |
Mild | 6 (46.2) |
Moderate | 1 (7.7) |
Severe | 6 (46.2) |
Site of AE, E | |
Non-ocular | 5 |
Left eye | 4 |
Right eye | 3 |
Both eyes | 1 |
Relationship to study drug or ocular injection, n (%) b | |
Not suspected | 13 (100.0) |
Action taken, n (%) b | |
No action taken: | 2 (15.4) |
Concomitant medication taken | 6 (46.2) |
Non-drug therapy given: | 4 (30.8) |
Hospitalization/prolonged: | 1 (7.7) |