Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Preferred term | 12 mg twice daily (n = 15) | All doses (n = 42) | 12 mg twice daily (n = 15) | All doses (n = 42) | 12 mg twice daily (n = 15) | All doses (n = 42) | 12 mg twice daily (n = 15) | All doses (n = 42) | 12 mg twice daily (n = 15) | All doses (n = 42) |
Adverse events related to study drug | 15 (100%) | 36 (85.7%) | 0 | 6 (14.3%) | 6 (40.0%) | 14 (33.3%) | 7 (46.7%) | 13 (31.0%) | 2 (13.3%) | 3 (7.1%) |
Rash | 7 (46.7%) | 26 (61.9%) | 6 (40.0%) | 21 (50.0%) | 1 (6.7%) | 5 (11.9%) | 0 | 0 | 0 | 0 |
Increased creatine phosphokinase | 13 (86.7%) | 25 (59.5%) | 3 (20.0%) | 6 (14.3%) | 6 (40.0%) | 13 (31.0%) | 2 (13.3%) | 3 (7.1%) | 2 (13.3%) | 3 (7.1%) |
Face edema | 12 (80.0%) | 21 (50.0%) | 11 (73.3%) | 19 (45.2%) | 0 | 1 (2.4%) | 1 (6.7%) | 1 (2.4%) | 0 | 0 |
Increased aspartate aminotransferase | 10 (66.7%) | 20 (47.6%) | 9 (60.0%) | 19 (45.2%) | 1 (6.7%) | 1 (2.4%) | 0 | 0 | 0 | 0 |
Peripheral edema | 9 (60.0%) | 17 (40.5%) | 6 (40.0%) | 14 (33.3%) | 1 (6.7%) | 1 (2.4%) | 2 (13.3%) | 2 (4.8%) | 0 | 0 |
Diarrhea | 7 (46.7%) | 14 (33.3%) | 5 (33.3%) | 11 (26.2%) | 2 (13.3%) | 2 (4.8%) | 0 | 1 (2.4%) | 0 | 0 |
Increased alanine aminotransferase | 6 (40.0%) | 14 (33.3%) | 5 (33.3%) | 13 (31.0%) | 1 (6.7%) | 1 (2.4%) | 0 | 0 | 0 | 0 |
Paronychia | 5 (33.3%) | 8 (19.0%) | 5 (33.3%) | 7 (16.7%) | 0 | 1 (2.4%) | 0 | 0 | 0 | 0 |
Asthenia | 4 (26.7%) | 7 (16.7%) | 2 (13.3%) | 3 (7.1%) | 1 (6.7%) | 1 (2.4%) | 1 (6.7%) | 3 (7.1%) | 0 | 0 |
Dermatitis acneiform | 4 (26.7%) | 6 (14.3%) | 2 (13.3%) | 3 (7.1%) | 1 (6.7%) | 1 (2.4%) | 1 (6.7%) | 2 (4.8%) | 0 | 0 |
Increased creatine phosphokinase MB | 3 (20.0%) | 6 (14.3%) | 3 (20.0%) | 4 (9.5%) | 0 | 2 (4.8%) | 0 | 0 | 0 | 0 |
Proteinuria | 4 (26.7%) | 6 (14.3%) | 3 (20.0%) | 4 (9.5%) | 1 (6.7%) | 2 (4.8%) | 0 | 0 | 0 | 0 |
Skin fissures | 4 (26.7%) | 5 (11.9%) | 4 (26.7%) | 5 (11.9%) | 0 | 0 | 0 | 0 | 0 | 0 |
Pyrexia | 4 (26.7%) | 5 (11.9%) | 2 (13.3%) | 3 (7.1%) | 1 (6.7%) | 1 (2.4%) | 1 (6.7%) | 1 (2.4%) | 0 | 0 |
Decreased white blood cell count | 2 (13.3%) | 5 (11.9%) | 1 (6.7%) | 3 (7.1%) | 1 (6.7%) | 2 (4.8%) | 0 | 0 | 0 | 0 |
Decreased neutrophil count | 2 (13.3%) | 5 (11.9%) | 1 (6.7%) | 3 (7.1%) | 1 (6.7%) | 2 (4.8%) | 0 | 0 | 0 | 0 |
Anemia | 4 (26.7%) | 5 (11.9%) | 2 (13.3%) | 3 (7.1%) | 2 (13.3%) | 2 (4.8%) | 0 | 0 | 0 | 0 |