AEs in the Sailing Study and extension study
Conbercept (n=125) | Laser (n=124) | Conbercept (n=76) | Laser (n=80) | |
Events | Sailing Study | Extension study | ||
All AEs | 109 (87.2) | 108 (87.1) | 61 (80.3) | 75 (93.8) |
Treatment-related AEs | 45 (36.0) | 19 (15.3) | 30 (39.5) | 34 (42.5) |
SAEs | 22 (17.6) | 24 (19.4) | 11 (14.5) | 16 (20.0) |
Death | 0 | 1 (0.8) | 0 | 1 (1.3) |
All ocular AEs | 72 (57.6) | 49 (39.5) | 39 (51.3) | 50 (62.5) |
Treatment-related ocular AEs | 40 (32.0) | 12 (9.7) | 27 (35.5) | 31 (38.8) |
Ocular SAEs | 6 (4.8) | 2 (1.6) | 7 (9.2) | 4 (5.0) |
AEs occurring in >5% of patients in either group | ||||
Visual impairment | 25 (20.0) | 24 (19.4) | 3 (3.9) | 5 (6.3) |
Upper respiratory tract infection | 25 (20.0) | 22 (17.7) | 9 (11.8) | 15 (18.8) |
Intraocular hypertension | 16 (12.8) | 6 (4.8) | 11 (14.5) | 13 (16.3) |
Systemic hypertension | 15 (12.0) | 13 (10.5) | 5 (6.6) | 5 (6.3) |
Elevated blood pressure* | 15 (12.0) | 7 (5.6) | 3 (3.9) | 10 (12.5) |
Subconjunctival haemorrhage | 15 (12.0) | 4 (3.2) | 2 (2.6) | 4 (5.0) |
Diabetic nephropathy | 9 (7.2) | 13 (10.5) | 1 (1.3) | 5 (6.3) |
Hyperlipaemia | 7 (5.6) | 9 (7.3) | 3 (3.9) | 3 (3.8) |
Urinary tract infection | 7 (5.6) | 6 (4.8) | 2 (2.6) | 3 (3.8) |
Elevated blood glucose | 6 (4.8) | 7 (5.6) | 6 (7.9) | 2 (2.5) |
Vitreous haemorrhage | 6 (4.8) | 7 (5.6) | 4 (5.3) | 4 (5.0) |
Nasopharyngitis | 6 (4.8) | 6 (4.8) | 4 (5.3) | 2 (2.5) |
Elevated blood urea | 5 (4.0) | 7 (5.6) | 1 (1.3) | 2 (2.5) |
Detected urine protein | 2 (1.6) | 12 (9.7) | 1 (1.3) | 1 (1.3) |
Xerophthalmia | 2 (1.6) | 7 (5.6) | 3 (3.9) | 2 (2.5) |
Vitreousopacity | 0 | 6 (4.8) | 4 (5.3) | 2 (2.5) |
*Elevated blood pressure but not enough to diagnose hypertension.
AE, adverse event; SAE, serious adverse event.