Table 2.

Summary of toxicity

AEGrade 1Grade 2Grade 3Grade 4
Total no. of AEs 308 (93) 96 (77) 21 (30) 7 (10) 
Grade 2-4 TRAE     
 Leukopenia  4 (7) 5 (13) 1 (3) 
 Neutropenia  3 (7)  4 (10) 
 Transaminitis  3 (10) 3 (7)  
 Diarrhea/colitis  1 (3) 3 (7)  
 Pneumonitis/dyspnea  3 (7) 1 (3)  
 Hypothyroidism  4 (7)   
 Rash  3 (7)   
 Lymphopenia  1 (3) 1 (3)  
 Thrombocytopenia  2 (7)   
 Febrile neutropenia    1 (3) 
 Pulmonary hemorrhage*   1 (3)  
 Hyperthyroidism  1 (3)   
 Arthritis  1 (3)   
 Fatigue  1 (3)   
 Neck pain  1 (3)   
 Creatinine increase  1 (3)   
 Blurred vision  1 (3)   
Total no. of TRAEs 82 (67) 30 (47) 14 (27) 6 (10) 
Grade 2-4 irAEs     
 Transaminitis  2 (7) 3 (7)  
 Pneumonitis/dyspnea/cough  4 (10) 1 (3)  
 Diarrhea/colitis  1 (3) 2 (7)  
 Rash  3 (7)   
 Hypothyroidism  3 (3)   
 Pulmonary hemorrhage*   1 (3)  
 Hyperthyroidism  1 (3)   
 Arthritis  1 (3)   
 Creatinine increase  1 (3)   
Total no. of irAEs 16 (33) 16 (33) 7 (20) 0 (0) 
AEGrade 1Grade 2Grade 3Grade 4
Total no. of AEs 308 (93) 96 (77) 21 (30) 7 (10) 
Grade 2-4 TRAE     
 Leukopenia  4 (7) 5 (13) 1 (3) 
 Neutropenia  3 (7)  4 (10) 
 Transaminitis  3 (10) 3 (7)  
 Diarrhea/colitis  1 (3) 3 (7)  
 Pneumonitis/dyspnea  3 (7) 1 (3)  
 Hypothyroidism  4 (7)   
 Rash  3 (7)   
 Lymphopenia  1 (3) 1 (3)  
 Thrombocytopenia  2 (7)   
 Febrile neutropenia    1 (3) 
 Pulmonary hemorrhage*   1 (3)  
 Hyperthyroidism  1 (3)   
 Arthritis  1 (3)   
 Fatigue  1 (3)   
 Neck pain  1 (3)   
 Creatinine increase  1 (3)   
 Blurred vision  1 (3)   
Total no. of TRAEs 82 (67) 30 (47) 14 (27) 6 (10) 
Grade 2-4 irAEs     
 Transaminitis  2 (7) 3 (7)  
 Pneumonitis/dyspnea/cough  4 (10) 1 (3)  
 Diarrhea/colitis  1 (3) 2 (7)  
 Rash  3 (7)   
 Hypothyroidism  3 (3)   
 Pulmonary hemorrhage*   1 (3)  
 Hyperthyroidism  1 (3)   
 Arthritis  1 (3)   
 Creatinine increase  1 (3)   
Total no. of irAEs 16 (33) 16 (33) 7 (20) 0 (0) 

“Treatment-related” refers to AEs judged to be at least possibly related to study treatment. The number of patients, expressed as the percentage of total patients, is given in parenthesis for grade 2-4 TRAEs. Events are ordered by frequency.

*

In a patient with prior cavitary tumor lesion.