Table 5

Incidence of adverse events

Adverse events

Placebo (n = 23)

100 mg/day 5-Loxin® (n = 24)

250 mg/day 5-Loxin® (n = 23)


Diarrhoea

3

2

2

Nausea

1

3

2

Vomiting

1

1

1

Abdominal pain

4

2

2

Pedal edema

0

1

0

Itching

2

1

4

General weakness

2

4

2

Constipation

0

0

1

Mild fever (up to 37.5°C)

1

2

2

Stomach burn

4

0

3

Allergya

3

0

1

Headache

0

0

1

Miscellaneousb

9

2

6

Sum of events

30

18

27


aAllergy includes redness of skin and sinus allergy. bMiscellaneous group includes body pain, loss of hair, chest pain and eye infection.

Sengupta et al. Arthritis Research & Therapy 2008 10:R85   doi:10.1186/ar2461

Open Data