Table 2.
Summary of treatment-emergent adverse events (safety population)
| TEAE | Overall Incidence, n (%) |
P Valuea Bim 10 µg vs. timolol |
P Valuea Bim 15 µg vs. timolol |
||
|---|---|---|---|---|---|
| Bimatoprost implant 10 µg (n = 175) |
Bimatoprost implant 15 µg (n = 176) |
Timolol BID (n = 173) |
|||
| Any TEAE | 131 (74.9) | 155 (88.1) | 122 (70.5) | 0.364 | < 0.001 |
| Any treatment-related TEAE | 84 (48.0) | 109 (61.9) | 36 (20.8) | < 0.001 | < 0.001 |
| Ocular | 84 (48.0) | 109 (61.9) | 35 (20.2) | < 0.001 | < 0.001 |
| Nonocular | 3 (1.7) | 5 (2.8) | 2 (1.2) | > 0.999 | 0.448 |
| Any serious TEAE | 22 (12.6) | 36 (20.5) | 16 (9.2) | 0.320 | 0.003 |
| Ocular | 6 (3.4) | 13 (7.4) | 0 | 0.030 | < 0.001 |
| Nonocular | 17 (9.7) | 25 (14.2) | 16 (9.2) | 0.882 | 0.151 |
| Deathb | 0 | 1 (0.6) | 1 (0.6) | 0.497 | > 0.999 |
BID twice daily, Bim bimatoprost implant, TEAE treatment-emergent adverse event
aP value based on chi-square test or Fisher exact test (when any frequency was < 5)
bDeath from tumor metastases (15 µg implant group) and complications of hip fracture (timolol group) considered to be unrelated to treatment