Table 6.
Number (%) of subjects reporting common (≥1% in either group) AEs by trial (safety populations)
| Trial 1
|
Trial 2
|
|||
|---|---|---|---|---|
| KPI-121 1% BID (n=125) | Vehiclea (n=126) | KPI-121 1% BID (n=261) | Vehicle BID (n=259) | |
|
| ||||
| Headache | 2 (1.6) | 3 (2.4) | 4 (1.5) | 4 (1.5) |
| Corneal edema | 2 (1.6) | 2 (1.6) | 0 | 0 |
| Eye pain | 1 (0.8) | 5 (4.0) | 3 (1.1) | 6 (2.3) |
| Photophobia | 1 (0.8) | 3 (2.4) | 1 (0.4) | 4 (1.5) |
| Eye irritation | 1 (0.8) | 3 (2.4) | 0 | 0 |
| Nasopharyngitis | 0 | 0 | 4 (1.5) | 1 (0.4) |
| Posterior capsule opacification | 0 | 0 | 3 (1.1) | 4 (1.5) |
| Cystoid macular edema | 0 | 0 | 3 (1.1) | 3 (1.2) |
| Instillation site pain | 0 | 0 | 1 (0.4) | 2 (1.2) |
| Ocular hyperemia | 0 | 5 (4.0) | 0 | 0 |
| Eye inflammation | 0 | 4 (3.2) | 0 | 0 |
| Ocular discomfort | 0 | 2 (1.6) | 0 | 0 |
Notes:
a
In Trial 1, the two vehicle groups (vehicle A [QID] and vehicle B [BID]) were pooled for all analyses. MedDRA version 16.1 was used to code all AEs in each trial. Preferred terms are listed in descending order of incidence for the KPI-121 1% BID group in Trial 1 and then the KPI-121 1% BID group in Trial 2.
Abbreviations: AE, adverse event; BID, twice daily; QID, four times daily.