Summary of AEs (safety-evaluable population, R/R cohorts, and 1L cohort)
| . | R/R MDS . | 1L MDS . | |
|---|---|---|---|
| Cohort A (n = 11) . | Cohort B (n = 14) . | Cohort C (n = 21) . | |
| Patients with at least 1 AE | 11 (100) | 14 (100) | 21 (100) |
| Total events, n | 59 | 186 | 427 |
| Grade 3-4 AE | 5 (45.5) | 13 (92.9) | 18 (85.7) |
| Grade 3-4 AE related to treatment | 1 (9.1) | 10 (71.4) | 13 (61.9) |
| Grade 5 (fatal) AE | 1 (9.1) | 2 (14.3) | 6 (28.6) |
| SAE | 5 (45.5) | 9 (64.3) | 15 (71.4) |
| SAE related to treatment with atezolizumab | 2 (18.2) | 4 (28.6) | 3 (14.3) |
| SAE related to treatment with azacitidine | NA | 5 (35.7) | 5 (23.8) |
| AE leading to treatment modification of atezolizumab | 1 (9.1) | 1 (7.1) | 5 (23.8) |
| AE leading to treatment modification of azacitidine | NA | 7 (50.0) | 3 (14.3) |
| AE leading to discontinuation of atezolizumab | 1 (9.1) | 5 (35.7) | 5 (23.8) |
| AE leading to discontinuation of azacitidine | NA | 3 (21.4) | 5 (23.8) |
| . | R/R MDS . | 1L MDS . | |
|---|---|---|---|
| Cohort A (n = 11) . | Cohort B (n = 14) . | Cohort C (n = 21) . | |
| Patients with at least 1 AE | 11 (100) | 14 (100) | 21 (100) |
| Total events, n | 59 | 186 | 427 |
| Grade 3-4 AE | 5 (45.5) | 13 (92.9) | 18 (85.7) |
| Grade 3-4 AE related to treatment | 1 (9.1) | 10 (71.4) | 13 (61.9) |
| Grade 5 (fatal) AE | 1 (9.1) | 2 (14.3) | 6 (28.6) |
| SAE | 5 (45.5) | 9 (64.3) | 15 (71.4) |
| SAE related to treatment with atezolizumab | 2 (18.2) | 4 (28.6) | 3 (14.3) |
| SAE related to treatment with azacitidine | NA | 5 (35.7) | 5 (23.8) |
| AE leading to treatment modification of atezolizumab | 1 (9.1) | 1 (7.1) | 5 (23.8) |
| AE leading to treatment modification of azacitidine | NA | 7 (50.0) | 3 (14.3) |
| AE leading to discontinuation of atezolizumab | 1 (9.1) | 5 (35.7) | 5 (23.8) |
| AE leading to discontinuation of azacitidine | NA | 3 (21.4) | 5 (23.8) |
Data presented as n (%).
1L, frontline; NA, not applicable; SAE, serious AE.