Adverse event | Participants experiencing adverse event % (n) | |||
Baseline liver function results | ||||
Normal | Abnormala | Unknown | All | |
Any adverse event | 16.3 (167) | 18.8 (3) | 33.3 (4) | 16.6 (174) |
Drug‐related adverse effect | 9.5 (663) | 7.6 (12) | 28.6 (10) | 9.6 (685) |
Adverse events leading to discontinuation of study drug | 0.6 (42) | 1.3 (2) | 28.6 (10) | 0.8 (54) |
Severe adverse event | 0.5 (35) | 0 (0) | 0 (0) | 0.5 (35) |
Life‐threatening adverse event | 0.1 (7) | 0.6 (1) | 2.9 (1) | 0.1 (9) |
Blood and lymphatic system disorders | 0.4 (31) | 0.6 (1) | 5.7 (2) | 0.5 (34) |
Cardiac disorders | 0.1 (6) | 0 (0) | 0 (0) | 0.1 (6) |
Gastrointestinal disorders | 7.1 (494) | 7.0 (11) | 28.6 (10) | 7.2 (515) |
Abbreviations: ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal. | ||||
aAbnormal baseline liver function test results defined as ALT/AST > 2 x ULN. |