Table 5.
Summary of TEAEs (safety analysis set)
| FE implant (N = 385), n (%) | SE implant (N = 378), n (%) | Sham/timolol (N = 386), n (%) | |
|---|---|---|---|
| TEAEs | |||
| Study eye | 138 (35.8) | 135 (35.7) | 73 (18.9) |
| Non-ocular or non-study eye | 121 (31.4) | 99 (26.2) | 108 (28.0) |
| Related to study treatment | |||
| Study eye | 74 (19.2) | 70 (18.5) | 9 (2.3) |
| Non-ocular or non-study eyea | 1 (0.3) | 2 (0.5) | 0 |
| Severe TEAEs | |||
| Study eye | 7 (1.8) | 6 (1.6) | 2 (0.5) |
| Non-ocular or non-study eye | 18 (4.7) | 18 (4.8) | 16 (4.1) |
| TEAEs leading to study discontinuation | |||
| Study eye | 7 (1.8) | 4 (1.1) | 3 (0.8) |
| Non-ocular or non-study eyeb | 2 (0.5) | 0 | 3 (0.8) |
| Serious TEAEs | |||
| Study eye | 1 (0.3) | 3 (0.8) | 0 |
| Non-ocular or non-study eye | 20 (5.2) | 20 (5.3) | 20 (5.2) |
| Deathsc | 3 (0.8) | 1 (0.3) | 6 (1.6) |
FE implant fast-eluting travoprost intracameral implant, SE implant slow-eluting travoprost intracameral implant, TEAE treatment-emergent adverse event
aNon-ocular or non-study eye treatment-related TEAEs included headache in one FE and SE implant subject, and rhinorrhea in one SE implant subject
bNon-ocular or non-study eye TEAEs leading to study discontinuation included benign brain neoplasm and hip fracture in FE implant subjects; uterine cancer, bradycardia, and hypersensitivity in sham/timolol subjects
cDeaths included metastatic lung cancer and aortic aneurysm in single FE implant subjects; hepatic cancer/esophageal carcinoma in a single SE implant subject; coronavirus infection in three sham/timolol subjects, and cardio-respiratory arrest, breast cancer, and road traffic accident in single sham/timolol subjects