|
Adverse events reported during the 6-week treatment with WS® 5570 or placebo (safety analysis set) |
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| 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 |
|
|
|
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| 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 |
|
Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 5.1. *Patients may have experienced more than one adverse event. | |||||
Kasper et al. BMC Medicine 2006 4:14 doi:10.1186/1741-7015-4-14 |
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