Table 9.
Number (%) of patients with the most commonly reported system organ classes in the treatment and extension periods, safety population.
| System organ class | Treatment period | Extension period | ||
|---|---|---|---|---|
| PRM(n = 394) | Placebo(n = 395) | PRM(n = 534) | Placebo(n = 177) | |
| Infections and infestations | 38 (9.6) | 43 (10.9) | 176 (33.0) | 60 (33.9) |
| Gastrointestinal disorders | 18 (4.6) | 31 (7.8) | 113 (21.2) | 37 (20.9) |
| Musculoskeletal and connective tissue disorders | 21 (5.3) | 21 (5.3) | 113 (21.2) | 34 (19.2) |
| Nervous system disorders | 19 (4.8) | 23 (5.8) | 47 (8.8) | 19 (10.7) |
| Respiratory, thoracic and mediastinal disorders | 12 (3.0) | 16 (4.1) | 47 (8.8) | 18 (10.2) |
| Skin and subcutaneous tissue disorders | 12 (3.0) | 9 (2.3) | 43 (8.1) | 13 (7.3) |
| Injury, poisoning and procedural complications | 8 (2.0) | 2 (0.5) | 35 (6.6) | 13 (7.3) |
| Renal and urinary disorders | 9 (2.3) | 4 (1.0) | 29 (5.4) | 7 (4.0) |
| General disorders and administration site disorders | 5 (1.3) | 5 (1.3) | 28 (5.2) | 16 (9.0) |
| Investigations | 5 (1.3) | 7 (1.8) | 24 (4.5) | 9 (5.1) |
| Eye disorders | 5 (1.3) | 1 (0.3) | 20 (3.7) | 6 (3.4) |
| Psychiatric disorders | 5 (1.3) | 4 (1.0) | 17 (3.2) | 13 (7.3) |
| Vascular disorders | 2 (0.5) | 0 (0) | 16 (3.0) | 5 (2.8) |
| Cardiac disorders | 0 (0) | 1 (0.3) | 15 (2.8) | 2 (1.1) |
| Ear and labyrinth disorders | 0 (0) | 1 (0.3) | 13 (2.4) | 2 (1.1) |
| Reproductive system and breast disorders | 3 (0.8) | 3 (0.8) | 12 (2.2) | 1 (0.6) |
| Metabolism and nutrition disorders | 1 (0.3) | 2 (0.5) | 7 (1.3) | 4 (2.3) |
| Surgical and medical procedures | 1 (0.3) | 2 (0.5) | 7 (1.3) | 6 (3.4) |
PRM, prolonged release melatonin.