Table 5 |
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|
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 |
|||
|
|
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|
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 |
|
|
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|
Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 5.1. *Patients may have experienced more than one adverse event. |
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|
Kasper et al. BMC Medicine 2006 4:14 doi:10.1186/1741-7015-4-14 |
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