Table 5 Adverse events reported during the 6-week treatment with WS® 5570 or placebo (safety analysis set)
Type of adverse event (MedDRA System Organ Class) | Number (%) of patients with adverse events* | p-value | |||
|---|---|---|---|---|---|
WS® 5570 600 mg/day N = 123 | WS® 5570 1200 mg/day N = 127 | Placebo N = 82 | WS® 5570 600 mg/day vs placebo | WS® 5570 1200 mg/day vs placebo | |
All adverse events | 49 (39.8) | 50 (39.4) | 22 (26.8) | 0.07 | 0.07 |
Ear and labyrinth disorders | 3 (2.4) | 2 (1.6) | 1 (1.2) | 0.65 | 1.00 |
Eye disorders | 0 (0.0) | 1 (0.8) | 0 (0.0) | 1.00 | 1.00 |
Gastrointestinal disorders | 24 (19.5) | 30 (23.6) | 13 (15.9) | 0.58 | 0.22 |
General disorders and administration site conditions | 2 (1.6) | 2 (1.6) | 0 (0.0) | 0.52 | 0.52 |
Infections and infestations | 7 (5.7) | 4 (3.2) | 2 (2.4) | 0.32 | 1.00 |
Injury, poisoning and procedural complications | 1 (0.8) | 1 (0.8) | 1 (1.2) | 1.00 | 1.00 |
Investigations | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1.00 | 1.00 |
Metabolism and nutrition disorders | 1 (0.8) | 1 (0.8) | 1 (1.2) | 1.00 | 1.00 |
Musculosceletal and connective tissue disorder | 1 (0.8) | 2 (1.6) | 1 (1.2) | 1.00 | 1.00 |
Nervous system disorder | 6 (4.9) | 6 (4.7) | 2 (2.4) | 0.48 | 0.49 |
Psychiatric disorders | 2 (1.6) | 2 (1.6) | 0 (0.0) | 0.52 | 0.52 |
Renal and unrinary disorders | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1.00 | 1.00 |
Reproductive system and breast disorders | 1 (0.8) | 2 (1.6) | 0 (0.0) | 1.00 | 0.52 |
Respiratory, thoracic and mediastinal disorders | 4 (3.3) | 5 (3.9) | 2 (2.4) | 1.00 | 0.71 |
Skin and subcutaneous disorders | 4 (3.3) | 2 (1.6) | 4 (4.9) | 0.72 | 0.21 |
Vascular disorders | 1 (0.8) | 1 (0.8) | 0 (0.0) | 1.00 | 1.00 |