Table 4. Distribution of subjects with at least 1 TEAE to primary system organ classes.
| Number of subjects with at least 1 TEAE | Total (n = 496) | Active (n = 370) | Placebo (n = 126) |
|---|---|---|---|
| Overall | 293 (59.1%) | 231 (62.4%) | 62 (49.2%) |
| Nervous system disorders | 119 (24.0%) | 92 (24.9%) | 27 (21.4%) |
| General disorders and administration site conditions | 84 (16.9%) | 65 (17.6%) | 19 (15.1%) |
| Gastrointestinal disorders | 67 (13.5%) | 57 (15.4%) | 10 (7.9%) |
| Vascular disorders | 43 (8.7%) | 35 (9.5%) | 8 (6.3%) |
| Musculoskeletal and connective tissue disorders | 37 (7.5%) | 30 (8.1%) | 7 (5.6%) |
| Respiratory, thoracic, and mediastinal disorders | 34 (6.9%) | 30 (8.1%) | 4 (3.2%) |
| Infections and infestations | 31 (6.3%) | 24 (6.5%) | 7 (5.6%) |
| Cardiac disorders | 24 (4.8%) | 20 (5.4%) | 4 (3.2%) |
| Investigations | 21 (4.2%) | 13 (3.5%) | 8 (6.3%) |
| Eye disorders | 19 (3.8%) | 17 (4.6%) | 2 (1.6%) |
| Skin and subcutaneous tissue disorders | 17 (3.4%) | 15 (4.1%) | 2 (1.6%) |
| Renal and urinary disorders | 13 (2.6%) | 12 (3.2%) | 1 (0.8%) |
| Injury, poisoning, and procedural complications | 11 (2.2%) | 8 (2.2%) | 3 (2.4%) |
| Psychiatric disorders | 11 (2.2%) | 8 (2.2%) | 3 (2.4%) |
| Ear and labyrinth disorders | 7 (1.4%) | 5 (1.4%) | 2 (1.6%) |
| Reproductive system and breast disorders | 3 (0.6%) | 3 (0.8%) | 0 |
| Metabolism and nutrition Disorder | 2 (0.4%) | 0 | 2 (1.6%) |
| Blood and lymphatic system disorders | 1 (0.2%) | 0 | 1 (0.8%) |
TEAE = treatment-emergent adverse events.