All causality adverse events N = 391 | Treatment-related adverse events N = 391 | |
---|---|---|
Any adverse event | 89 (22.8) | 60 (15.3) |
Discontinued due to adverse event | 22 (5.6) | 20 (5.1) |
System Organ Class | ||
Cardiac disorders | 3 (0.8) | 2 (0.5) |
Ear and labyrinth disorders | 4 (1.0) | 3 (0.8) |
Eye disorders | 40 (10.2) | 34 (8.7) |
Gastrointestinal disorders | 6 (1.5) | 3 (0.8) |
General disorders and administration site conditions | 11 (2.8) | 8 (2.0) |
Immune system disorders | 2 (0.5) | 2 (0.5) |
Infections and infestations | 8 (2.0) | 1 (0.3) |
Injury, poisoning, and procedural complications | 2 (0.5) | 1 (0.3) |
Investigations | 2 (0.5) | 2 (0.5) |
Metabolism and nutrition disorders | 1 (0.3) | 1 (0.3) |
Musculoskeletal and connective tissue disorders | 2 (0.5) | - |
Nervous system disorders | 12 (3.1) | 8 (2.0) |
Psychiatric disorders | 8 (2.0) | 6 (1.5) |
Reproductive system and breast disorders | 1 (0.3) | 1 (0.3) |
Respiratory, thoracic, and mediastinal disorders | 4 (1.0) | 3 (0.8) |
Skin and subcutaneous tissue disorders | 10 (2.6) | 9 (2.3) |
Surgical and medical procedures | 2 (0.5) | - |
Vascular disorders | 6 (1.5) | 2 (0.5) |