Table 2 Adverse events considered possibly related to study medication

Adverse eventPetasites 75 mg, n = 75Petasites 50 mg, n = 79Placebo, n = 76
All adverse events were classified according to the Medical Dictionary of Regulatory Affairs, and treatment groups were compared. No significant differences between treatment groups were observed in relation to incidence of adverse events, with the exception of an increase in burping observed in association with both doses of Petasites extract.
Cardiac disorders1 (1.3%)00
Disorders of ears and labyrinth01 (1.3%)1 (1.3%)
Gastrointestinal disorders17 (22.4%)20 (25.6%)5 (6.7%)
General disorders1 (1.3%)01 (1.3%)
Infections and infestations020
Neurologic disorders1 (1.3%)4 (5.1%)1 (1.3%)
Neurologic disorders, general disorders01 (1.3%)0
Renal and urinary disorders001 (1.3%)
Respiratory, thoracic, and mediastinal disorders1 (1.3%)00
Disorders of eye001 (1.3%)
Skin and subcutaneous tissue disorders2 (2.6%)01 (1.3%)