ASP8232 (N = 32) | ASP8232/ranibizumab (N = 33) | Ranibizumab (N = 31) | ||||
---|---|---|---|---|---|---|
n (%) | E | n (%) | E | n (%) | E | |
Overall TEAEs | 21 (65.6) | 43 | 17 (51.5) | 50 | 19 (61.3) | 51 |
Ocular TEAEs | 10 (31.3) | 14 | 13 (39.4) | 21 | 12 (38.7) | 23 |
Systemic TEAEsa | 17 (53.1) | 29 | 13 (39.4) | 29 | 15 (48.4) | 28 |
Drug-related TEAEs | 2 (6.3) | 6 | 3 (9.1) | 3 | 3 (9.7) | 3 |
Drug-related ocular TEAEs | 1 (3.1) | 1 | 1 (3.0) | 1 | 2 (6.5) | 2 |
Drug-related systemic TEAEs | 2 (6.3) | 5 | 2 (6.1) | 2 | 1 (3.2) | 1 |
Serious TEAEs | 3 (9.4) | 3 | 1 (3.0) | 1 | 3 (9.7) | 3 |
TEAEs leading to permanent discontinuation of study drug | 2 (6.3) | 2 | 1 (3.0) | 1 | 0 | 0 |
Drug-related TEAEs leading to permanent discontinuation of study drug | 1 (3.1) | 1 | 0 | 0 | 0 | 0 |
TEAEs reported in ≥ 5% of patients in any treatment group System organ class Preferred term (MedDRA v15.1) | ||||||
Endocrine disorders | 0 | 2 (6.1) | 0 | |||
Hypothyroidism | 0 | 2 (6.1) | 0 | |||
Eye disorders | 8 (25.0) | 13 (39.4) | 12 (38.7) | |||
Conjunctival hemorrhage | 0 | 3 (9.1) | 0 | |||
Diabetic retinal edema | 3 (9.4) | 1 (3.0) | 2 (6.5) | |||
Retinal aneurysm | 0 | 0 | 2 (6.5) | |||
Retinal exudates | 2 (6.3) | 2 (6.1) | 1 (3.2) | |||
Visual acuity reduced | 0 | 2 (6.1) | 1 (3.2) | |||
Vitreous floaters | 1 (3.1) | 2 (6.1) | 1 (3.2) | |||
Vitreous hemorrhage | 0 | 2 (6.1) | 2 (6.5) | |||
Gastrointestinal disorders | 1 (3.1) | 2 (6.1) | 1 (3.2) | |||
Vomiting | 0 | 2 (6.1) | 0 | |||
Metabolism and nutrition disorders | 3 (9.4) | 3 (9.1) | 3 (9.7) | |||
Worsening type 2 DM | 2 (6.3) | 3 (9.1) | 0 |