Table 3.
Adverse events.
| No. of patients (%) | |
|---|---|
| AE | 114 (100) |
| Treatment-related AE | 104 (91.2) |
| Grade ≥3 AE | 91 (79.8) |
| Treatment-related AE grade ≥3 | 49 (43.0) |
| Serious AE | 70 (61.4) |
| Treatment-related serious AE | 24 (21.1) |
| Discontinuation for AE | 45 (39.5) |
| Death | 6 (5.3) |
| Death from treatment-related AE | 0 |
| Most commona treatment-related AEs by preferred termb | |
| Drug eruption | 62 (54.4) |
| Infusion-related reaction | 42 (36.8) |
| Fatigue | 29 (25.4) |
| Diarrhea | 20 (17.5) |
| ALT increased | 16 (14.0) |
| AST increased | 16 (14.0) |
| Nausea | 13 (11.4) |
| Vomiting | 13 (11.4) |
| Pyrexia | 13 (11.4) |
| Anemia | 12 (10.5) |
| Arthralgia | 10 (8.8) |
| Lipase increased | 8 (7.0) |
| Alkaline phosphatase increased | 7 (6.1) |
| Most commonc treatment-related grade ≥3 AEs by preferred termb | |
| Drug eruption | 14 (12.3) |
| AST increased | 8 (7.0) |
| ALT increased | 6 (5.3) |
| Anemia | 4 (3.5) |
| Erythema multiforme | 3 (2.6) |
| Alkaline phosphatase increased | 3 (2.6) |
| Bilirubin increased | 3 (2.6) |
| Thombocytopenia | 3 (2.6) |
| Diarrhea | 3 (2.6) |
| Fatigue | 3 (2.6) |
| Bilirubin increased | 2 (1.8) |
| Diabetes mellitus | 2 (1.8) |
| Hyponatremia | 2 (1.8) |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities.
aOccurring in ≥5% of patients overall.
bCoded by MedDRA v18.1.
cOccurring in ≥1 patient overall.