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


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

Open Data