Table 2.
Summary of toxicity
| 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.