Table 4.
Ocular treatment emergent adverse events
| System organ class Preferred term | TOP1630 (N=31) | Placebo (N=30) | All subjects (N=61) | |||
|---|---|---|---|---|---|---|
| Events | Subjects n (%) | Events | Subjects n (%) | Events | Subjects n (%) | |
| Total | 5 | 4 (12.9) | 5 | 4 (13.3) | 10 | 8 (13.1) |
| Eye disorders | 3 | 2 (6.5) | 2 | 2 (6.7) | 5 | 4 (6.6) |
| Visual acuity reduced | 1 | 1 (3.2) | 1 | 1 (3.3) | 2 | 2 (3.3) |
| Eye discharge | 0 | 0 | 1 | 1 (3.3) | 1 | 1 (1.6) |
| Vision blurred | 1 | 1 (3.2) | 0 | 0 | 1 | 1 (1.6) |
| Vitreous floaters | 1 | 1 (3.2) | 0 | 0 | 1 | 1 (1.6) |
| General disorders and administration site conditions | 1 | 1 (3.2) | 3 | 3 (10.0) | 4 | 4 (6.6) |
| Instillation site pain | 1 | 1 (3.2) | 2 | 2 (6.7) | 3 | 3 (4.9) |
| Instillation site discomfort | 0 | 0 | 1 | 1 (3.3) | 1 | 1 (1.6) |
| Injury, poisoning, and procedural complications | 1 | 1 (3.2) | 0 | 0 | 1 | 1 (1.6) |
| Procedural pain | 1 | 1 (3.2) | 0 | 0 | 1 | 1 (1.6) |
Notes: SOCs are listed in the order of descending frequency for all subjects. PTs are listed in the order of descending frequency within each SOC for all subjects. N in the headers represents the number of subjects in each respective treatment group within the safety population. Subjects experiencing more than one TEAE within a given SOC or PT are counted once within that SOC or PT. Percentages are based on the total number of subjects in each treatment group. TEAEs were coded using MedDRA version 20.0.
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class; TEAE, treatment-emergent adverse event.