Table 7 Adverse events, N = 2339
All causalities n (%) | Treatment related n (%) | |
|---|---|---|
All adverse events | ||
Number of events | 185 | 88 |
Subjects with: | ||
≥1 adverse event | 148 (6.3) | 72 (3.1) |
≥1 serious adverse event | 54 (2.3) | 3 (0.1) |
≥1 severe adverse event | 70 (3.0) | 15 (0.6) |
Discontinued FC due to adverse event | 69 (2.9) | 52 (2.2) |
Dose reduced/temporarily discontinued FC due to adverse event | 22 (0.9) | 8 (0.3) |
All Ocular Adverse Events | ||
Number of events | 99 | 44 |
Subjects with: | ||
≥1 adverse event | 84 (3.6) | 39 (1.7) |
≥1 serious adverse event | 29 (1.2) | 2 (0.1) |
≥1 severe adverse event | 35 (1.5) | 5 (0.2) |
Discontinued FC due to adverse event | 41 (1.8) | 28 (1.2) |
Dose reduced/temporarily discontinued FC due to adverse event | 19 (0.8) | 6 (0.3) |