Table 3.

TRAEs

TRAEs (N = 243)Any gradeGrade 3 or 4
Patients with TRAEs, n (%) 198 (81.5) 67 (27.6) 
TRAEs occurring in ≥10% of patients, n (%)   
Fatigue 61 (25.1) 2 (0.8) 
Diarrhea 39 (16.0) 2 (0.8) 
Infusion-related reaction 34 (14.0) 1 (0.4) 
Rash 29 (11.9) 2 (0.8) 
Nausea 27 (11.1) 
Pruritus 25 (10.3) 
Immune-mediated AEs within 100 d of last dose   
Hypothyroidism/thyroiditis 35 (14.4) 
Rash 29 (11.9) 4 (1.6) 
Hepatitis 15 (6.2) 12 (4.9) 
Pneumonitis 15 (6.2) 2 (0.8) 
Hypersensitivity/infusion reactions 13 (5.3) 2 (0.8) 
Diarrhea/colitis 6 (2.5) 5 (2.1) 
Hyperthyroidism 6 (2.5) 
Nephritis and renal dysfunction 3 (1.2) 1 (0.4) 
Diabetes mellitus 2 (0.8) 1 (0.4) 
Adrenal insufficiency 1 (0.4) 
TRAEs (N = 243)Any gradeGrade 3 or 4
Patients with TRAEs, n (%) 198 (81.5) 67 (27.6) 
TRAEs occurring in ≥10% of patients, n (%)   
Fatigue 61 (25.1) 2 (0.8) 
Diarrhea 39 (16.0) 2 (0.8) 
Infusion-related reaction 34 (14.0) 1 (0.4) 
Rash 29 (11.9) 2 (0.8) 
Nausea 27 (11.1) 
Pruritus 25 (10.3) 
Immune-mediated AEs within 100 d of last dose   
Hypothyroidism/thyroiditis 35 (14.4) 
Rash 29 (11.9) 4 (1.6) 
Hepatitis 15 (6.2) 12 (4.9) 
Pneumonitis 15 (6.2) 2 (0.8) 
Hypersensitivity/infusion reactions 13 (5.3) 2 (0.8) 
Diarrhea/colitis 6 (2.5) 5 (2.1) 
Hyperthyroidism 6 (2.5) 
Nephritis and renal dysfunction 3 (1.2) 1 (0.4) 
Diabetes mellitus 2 (0.8) 1 (0.4) 
Adrenal insufficiency 1 (0.4) 
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