Table 2.
Common AE
|
Any grade (%)
|
95%CI
|
Grade ≥ 3 (%)
|
95%CI
|
Fatigue | 15.8 | 11.1-20.5 | 1.2 | 0.6-1.9 |
Infusion reaction | 13.8 | 1.3-26.3 | 0.6 | -0.2-1.4 |
Pruritus | 13.1 | 9.8-16.4 | NA | NA |
Decreased appetite | 9.6 | 5.7-13.5 | 0.9 | 0.2-1.6 |
Nausea | 9.4 | 4.1-14.6 | 1.4 | -2.5-5.4 |
Abdominal pain | 9.3 | -9.5-28.1 | 2.8 | -3.4-9.0 |
Diarrhea | 8.3 | 4.7-11.8 | 0.6 | 0.2-0.9 |
Pyrexia | 8.0 | 1.3-14.6 | NA | NA |
Vomiting | 7.8 | 0.1-15.4 | NA | NA |
Rash | 7.3 | 5.2-9.4 | 0.9 | -0.1-1.8 |
Arthralgia | 6.2 | 3.4-9.0 | NA | NA |
Hypothyroidism | 4.4 | 2.0-6.7 | 0.4 | 0-0.9 |
Elevated AST | 4.1 | 2.1-6.2 | 1.5 | -0.6-3.5 |
Asthenia | 3.2 | 1.3-5.1 | 0.7 | -0.2-1.6 |
Elevated ALT | 2.7 | 1.2-4.1 | 0.9 | -0.4-2.1 |
Pneumonitis | 2.7 | 0-5.4 | 0.5 | 0-1.0 |
Elevated lipase | 0.9 | -0.4-2.2 | 0.7 | -0.2-1.6 |
Colitis | 0.8 | 0.2-1.4 | 0.4 | 0-0.8 |
AEs: Adverse events; CI: Confidence interval; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; NA: Not available.