Table 2.
AE | Grade 1 | Grade 2 | Grade 3 | Grade 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.