Table 3 AEs leading to treatment discontinuation in three or more patients

Any AE leading to treatment discontinuation

48 (12)

 Investigations

19 (5)

  Increased ALT

11 (3)

  Increased AST

5 (1)

  Increased hepatic enzyme

4 (<1)

 Skin and subcutaneous tissue disorders

12 (3)

  Allergic dermatitis

3 (<1)

 Gastrointestinal disorders

4 (<1)

  Colitis

3 (<1)

 Hepatobiliary disorders

4 (<1)

 Infections and infestations

4 (<1)