Table 3.
Treatment-related adverse events
| All patients (n = 55) | ||
|---|---|---|
| Treatment-related adverse event summary | ||
| Any | 38 (69) | |
| Grade 3–5 | 13 (24) | |
| Seriousa | 7 (13) | |
| Led to discontinuation | 11 (20) | |
| Led to death | 1 (2)b | |
| Treatment-related adverse events with incidence ≥ 5% | Any grade | Grade 3/4 |
|---|---|---|
| Fatigue | 12 (22) | 1 (2) |
| Pruritus | 12 (22) | 0 |
| Lipase increased | 10 (18) | 5 (9) |
| Asthenia | 8 (15) | 1 (2) |
| ALT increased | 8 (15) | 0 |
| AST increased | 7 (13) | 1 (2) |
| Arthralgia | 7 (13) | 0 |
| Amylase increased | 5 (9) | 0 |
| Rash | 5 (9) | 0 |
| Diarrhea | 4 (7) | 0 |
| Dysgeusia | 4 (7) | 0 |
| Eczema | 4 (7) | 0 |
| Blood CPK increased | 3 (5) | 0 |
| Dry mouth | 3 (5) | 0 |
| Headache | 3 (5) | 0 |
| Hyperthyroidism | 3 (5) | 0 |
| Hypothyroidism | 3 (5) | 0 |
| Muscular weakness | 3 (5) | 1 (2) |
| Nausea | 3 (5) | 0 |
Data are n (%)
Treatment-related adverse events were determined by the investigator to be related to study treatment
ALT alanine aminotransferase, AST aspartate aminotransferase, CPK creatinine phosphokinase
aAny adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an existing inpatient hospitalization, results in a congenital anomaly or birth defect, or any other important medical event
bOne patient died of Guillain-Barré syndrome and this was considered related to treatment