Table 4.
Overall Safety Summary
| Cohort 1 n = 31 |
Cohort 2 n = 93 |
Cohort 3 n = 13 |
All N = 137 |
|
|---|---|---|---|---|
| Median treatment duration, months | 4.3 | 2.5 | 3.5 | 2.9 |
| All grade AEs (any cause), n (%) | 31 (100) | 92 (99) | 13 (100) | 136 (99) |
| Treatment-related AEs, n (%) | 25 (81) | 62 (67) | 9 (69) | 96 (70) |
| Grade 3–4 AEs (any cause), n (%) | 16 (52) | 53 (57) | 7 (54) | 76 (56) |
| Treatment-related grade 3–4 AEs, n (%) | 5 (16) | 18 (19) | 2 (15) | 25 (18) |
| Grade 5 AEs (any cause), n (%)a | 1 (3) | 3 (3) | 0 (0) | 4 (3) |
| Treatment-related grade 5 AEs, n (%) | 0 (0) | 1 (1) | 0 (0) | 1 (1) |
| Patients withdrawing from treatment due to AEs, n (%) | 3 (10) | 5 (5) | 0 (0) | 8 (6) |
a
Grade 5 AEs occurring ≤30 days after last treatment dose included cardiac arrest, cardiac tamponade, and hemoptysis in Cohort 1 and disseminated intravascular coagulation, constrictive pericarditis, and respiratory disorder in Cohort 2; of these, only constrictive pericarditis was considered related to atezolizumab. Grade 5 AEs occurring >30 days after last treatment dose included euthanasia and pneumonia.
AE, adverse event.