Table 4.
Exposure-adjusted hepatic adverse events by observation period
| Atezo + bev | Sorafenib | |||||||
|---|---|---|---|---|---|---|---|---|
| 0 to ≤3 months | >3 to ≤6 months | >6 to ≤12 months | Beyond 12 months | 0 to ≤3 months | >3 to ≤6 months | >6 to ≤12 months | Beyond 12 months | |
| HBV analysis population | ||||||||
| Patients exposed, n | 108 | 95 | 76 | 11 | 42 | 23 | 15 | 2 |
| Total exposure, person-months | 305.0 | 253.8 | 229.4 | 23.8 | 106.0 | 56.8 | 38.3 | 1.3 |
| Total events, n (rate)a | 118 (39) | 100 (39) | 76 (33) | 0 | 54 (51) | 6 (11) | 11 (29) | 0 |
| Hepatic AEs, n (rate)b | 56 (18) | 45 (18) | 32 (14) | 0 | 23 (22) | 3 (5) | 5 (13) | 0 |
| HCV analysis population | ||||||||
| Patients exposed, n | 37 | 33 | 27 | 5 | 21 | 12 | 9 | 0 |
| Total exposure, person-months | 105.2 | 91.4 | 91.4 | 8.3 | 52.8 | 30.7 | 16.4 | 0 |
| Total events, n (rate)a | 24 (23) | 20 (22) | 6 (7) | 0 | 20 (38) | 4 (13) | 18 (109.5) | 0 |
| Hepatic AEs, n (rate)b | 12 (11) | 10 (11) | 3 (3) | 0 | 10 (19) | 2 (7) | 6 (36) | 0 |
| Nonviral population | ||||||||
| Patients exposed, n | 191 | 135 | 112 | 16 | 98 | 34 | 23 | 3 |
| Total exposure, person-months | 463.9 | 364.6 | 371.8 | 24.2 | 197.4 | 90.4 | 71.9 | 6.8 |
| Total events, n (rate)a | 144 (31) | 96 (26) | 64 (17) | 5 (21) | 130 (66) | 13 (14) | 15 (21) | 0 |
| Hepatic AEs, n (rate)b | 67 (14) | 40 (11) | 29 (8) | 2 (8) | 62 (31) | 5 (6) | 6 (8) | 0 |
| Safety population | ||||||||
| Patients exposed, n | 329 | 257 | 210 | 31 | 156 | 67 | 45 | 5 |
| Total exposure, person-months | 855.4 | 693.0 | 677.2 | 56.1 | 342.0 | 171.9 | 123.7 | 8.1 |
| Total events, n (rate)3 | 284 (33) | 216 (31) | 146 (22) | 5 (9) | 200 (58) | 23 (13) | 44 (36) | 0 |
| Hepatic AEs, n (rate)b | 134 (16) | 95 (14) | 64 (10) | 2 (4) | 93 (27) | 10 (6) | 17 (14) | 0 |
AEs shown are those that were reported in ≥2% of patients exposed during any time window from the safety population. AE, adverse event; atezo, atezolizumab; bev, bevacizumab; HBV, hepatitis B virus; HCV, hepatitis C virus.
a
Multiple occurrences of the same AE in an individual are counted separately; rate is number of events over total exposure.
b
Multiple occurrences of the same AE in an individual are counted only once (highest grade); rate is number of patients who experienced event over total exposure.