Table 2.
Summary of adverse events in patients with autoimmune anterior uveitis treated with gevokizumab.
| N (%) | |
|---|---|
| Severity | |
| Mild | 40 (93%) |
| Moderate | 2 (5%) |
| Severe | 1 (2%) |
| Eye | |
| Non-ocular | 41 (95%) |
| OD | 1 (2%) |
| OS | 1 (2%) |
| Outcome | |
| Resolved | 37 (86%) |
| Resolved with sequelae | 2 (5%) |
| Resolved by convention | 4 (9%) |
|
Reasonable possibility that the investigational product caused the event |
|
| No | 37 (86%) |
| Yes | 6 (14%) |
Ocular side effects included eye redness and stye.
Systemic adverse events with reasonable possibility of causal relationship with treatment included injection site achiness, elevated liver enzymes, irritable bowel syndrome, and hypotension.
Resolved: The adverse event resolved while the participant was still in the study and the date of resolution is known.
Resolved with sequelae: The adverse event resolved while the participant was still in the study, but the participant retained pathological conditions resulting from the reported adverse event.
Resolved by convention: The adverse event was considered resolved as a result of not being able to follow the adverse event to its actual resolution.