System organ class Frequency
Gastrointestinal disorders 25
Nervous system disorders 14
General disorders and administration site conditions 7
Renal and urinary disorders 4
Eye disorders 3
Skin and subcutaneous tissue disorders 3
Ear and labyrinth disorders 2
Vascular disorders 2
Cardiac disorders 1
Investigations 1
Respiratory, thoracic and mediastinal disorders 1
Total 63
Table 4: Adverse drug reactions-SAS. SAS: Safety analysis set.