表 5.
阿替利珠单抗单药或联合化疗治疗患者的安全性数据汇总
Saftey summary on atezolizumab monotherapy and atezolizumab combined with chemotherapy
| Items | Atezolizumaba (n=100) | Atezolizumab+gemcitabine+cisplatina (n=20) |
| AE, adverse event; AESI, adverse event of special interest. a, percentages are based on n in the column heading. Multiple occurrences of the same AE in one individual are counted only once except for in the “AEs” row, in which multiple occurrences of the same AE are counted separately; b, dose modification not allowed with atezolizumab; c, due to disease progression, AE, or other causes; d, death. | ||
| Patients with ≥1 AE, n(%) | 98 (98.0) | 20 (100.0) |
| Serious AEs | 41 (41.0) | 8 (40.0) |
| Leading to treatment discontinuation | 16 (16.0) | 0 |
| Leading to any dose modification/interruptionb | 12 (12.0) | 2 (10.0) |
| Treatment-related | 18 (18.0) | 7 (35.0) |
| AEs leading to treatment discontinuation | 17 (17.0) | 0 |
| AEs leading to any dose modification/interruptionb | 28 (28.0) | 4 (20.0) |
| Treatment-related AEs | 84 (84.0) | 20 (100.0) |
| Leading to treatment discontinuation | 7 (7.0) | 0 |
| Leading to any dose modification/interruptionb | 17 (17.0) | 2 (10.0) |
| Grade 3/4 AEs | 51 (51.0) | 17 (85.0) |
| Treatment-related | 31 (31.0) | 17 (85.0) |
| Grade 5 AEs | 11 (11.0) | 1 (5.0) |
| Treatment-related | 1 (1.0)d | 0 |
| AESIs | 64 (64.0) | 12 (60.0) |
| AEs, n | 913 | 399 |
| Deathsc, n(%) | 71 (71.0) | 3 (15.0) |
| Withdrawal from study due to an AE, n(%) | 0 | 0 |