Table 3.
Hepatic adverse events in the safety population
| Hepatitis (diagnosis and laboratory abnormalities) |
Hepatitis (laboratory abnormalities) |
Hepatitis (diagnosis) |
||||
|---|---|---|---|---|---|---|
| atezo + bev (n = 329) | sorafenib (n = 156) | atezo + bev (n = 329) | sorafenib (n = 156) | atezo + bev (n = 329) | sorafenib (n = 156) | |
| All-cause AE | 142 (43) | 62 (40) | 126 (38) | 54 (35) | 43 (13) | 21 (13) |
| Grade 3/4 AEa | 70 (21) | 26 (17) | 55 (17) | 22 (14) | 23 (7) | 8 (5) |
| Grade 5 AE | 3 (1) | 2 (1) | 1 (<1) | 0 | 2 (1) | 2 (1) |
| Resolved AEb | 79 (56) | 30 (48) | 65 (52) | 24 (44) | 26 (60) | 11 (55) |
| AE leading to sorafenib withdrawal | NA | 4 (3) | NA | 1 (1) | NA | 3 (2) |
| AE leading to atezolizumab withdrawal | 8 (2) | NA | 5 (2) | NA | 4 (1) | NA |
| AE treated with systemic corticosteroids within 30 days | 24 (7) | 0 | 18 (5) | 0 | 8 (2) | 0 |
| AE leading to atezolizumab interruption | 38 (12) | NA | 30 (9) | NA | 11 (3) | NA |
| Serious AE | 35 (11) | 13 (8) | 18 (5) | 5 (3) | 22 (7) | 10 (6) |
Values are n (%). AE, adverse event; atezo, atezolizumab; bev, bevacizumab; NA, not applicable.
a
Refers to the highest grade experienced.
b
Percentages were calculated based on number of all-grade AEs.