Table 3.
Safety summary by ALBI/mALBI grade
| ALBI grade 1 | ALBI grade 2 | mALBI grade 2a | mALBI grade 2b | |||||
|---|---|---|---|---|---|---|---|---|
| atezolizumab + bevacizumab (n = 189)a | sorafenib (n = 81)a | atezolizumab + bevacizumab (n = 140)a | sorafenib (n = 75)a | atezolizumab + bevacizumab (n = 71)a | sorafenib (n = 37)a | atezolizumab + bevacizumab (n = 69)a | sorafenib (n = 38)a | |
| Treatment duration, median (range), months | Atezolizumab 10.4 (0–28) Bevacizumab 9.6 (0–28) |
2.9 (0–25) | Atezolizumab 6.1 (0–26) Bevacizumab 4.9 (0–25) | 2.8 (0–21) | Atezolizumab 6.9 (0–26) Bevacizumab 5.1 (0–25) |
1.9 (0–21) | Atezolizumab 4.3 (0–24) Bevacizumab 4.7 (0–24) |
2.8 (0–21) |
| All-grade AE, any cause, n (%) | 185 (98) | 79 (98) | 137 (98) | 75 (100) | 70 (99) | 37 (100) | 67 (97) | 38 (100) |
| Treatment-related all-grade AE | 169 (89) | 75 (93) | 115 (82) | 73 (97) | 61 (86) | 36 (97) | 54 (78) | 37 (97) |
| Grade 3/4 AE, n (%)b | 122 (65) | 47 (58) | 85 (61) | 42 (56) | 46 (65) | 21 (57) | 39 (57) | 21 (55) |
| Treatment-related grade 3/4 AEb | 90 (48) | 37 (46) | 53 (38) | 35 (47) | 27 (38) | 21 (57) | 26 (38) | 14 (37) |
| Serious AE, n (%) | 79 (42) | 22 (27) | 81 (58) | 29 (39) | 38 (54) | 12 (32) | 43 (62) | 17 (45) |
| Treatment-related serious AE | 41 (22) | 10 (12) | 35 (25) | 15 (20) | 12 (17) | 5 (14) | 23 (33) | 10 (26) |
| Grade 5 AE, n (%) | 7 (4) | 3 (4) | 16 (11) | 6 (8) | 5 (7) | 2 (5) | 11 (16) | 4 (11) |
| Treatment-related grade 5 AE | 2 (1)c | 0 | 4 (3) | 1 (1) | 1 (1)d | 0 | 3 (4)e | 1 (3)f |
| AE leading to withdrawal from any component, n (%) | 33 (17) | 7 (9) | 39 (28) | 11 (15) | 18 (25) | 5 (14) | 21 (30) | 6 (16) |
| AE leading to dose interruption of any study treatment, n (%) | 122 (65) | 28 (35) | 73 (52) | 40 (53) | 37 (52) | 19 (51) | 36 (52) | 21 (55) |
| AE leading to dose modification of sorafenib, n (%)g | 0 | 30 (37) | 0 | 28 (37) | 0 | 14 (38) | 0 | 14 (37) |
AE, adverse event; ALBI, albumin-bilirubin; mALBI; modified ALBI.
aSafety-evaluable population.
bHighest grade experienced.
cGastrointestinal hemorrhage (n = 1) and subarachnoid hemorrhage (n = 1).
dPneumonia (n = 1).
eAbnormal hepatic function (n = 1), liver injury (n = 1), and gastric ulcer perforation (n = 1).
fHepatic cirrhosis (n = 1).
gNo dose modification was allowed for atezolizumab or bevacizumab.