Table 2. Drug-Related Adverse Events*.
| Drug-Related Event | All Grades (N = 135) | Grade 3 or 4 (N = 135) |
|---|---|---|
| number (percent) | ||
| Any | 107 (79) | 17 (13) |
|
| ||
| Hypothyroidism | 11 (8) | 1 (1) |
|
| ||
| Gastrointestinal disorder
| ||
| Diarrhea | 27 (20) | 1 (1) |
|
| ||
| Nausea | 13 (10) | 0 |
|
| ||
| Abdominal pain | 7 (5) | 1 (1) |
|
| ||
| Generalized symptom
| ||
| Fatigue | 41 (30) | 2 (1) |
|
| ||
| Myalgia | 16 (12) | 0 |
|
| ||
| Headache | 14 (10) | 0 |
|
| ||
| Asthenia | 13 (10) | 0 |
|
| ||
| Pyrexia | 10 (7) | 0 |
|
| ||
| Chills | 9 (7) | 0 |
|
| ||
| Decreased appetite | 6 (4) | 1 (1) |
|
| ||
| Increase in aminotransferase level
| ||
| AST | 13 (10) | 2 (1) |
|
| ||
| ALT | 11 (8) | 0 |
|
| ||
| Renal failure | 3 (2) | 2 (1) |
|
| ||
| Respiratory disorder
| ||
| Cough | 11 (8) | 0 |
|
| ||
| Dyspnea | 6 (4) | 0 |
|
| ||
| Pneumonitis | 6 (4) | 0 |
|
| ||
| Skin disorder
| ||
| Rash | 28 (21) | 3 (2) |
|
| ||
| Pruritus | 28 (21) | 1 (1) |
|
| ||
| Vitiligo | 12 (9) | 0 |
*
Included are drug-related adverse events that occurred in at least five patients or drug-related grade 3 or 4 adverse events that occurred in at least two patients. ALT denotes alanine aminotransferase, and AST aspartate aminotransferase.