Table 3 Adverse events related to the study drug (incidence ≥ 5.0%)
Adverse event | 8MW0511 (n = 328), n(%) | PEG-rhG-CSF (n = 164), n(%) | ||
|---|---|---|---|---|
Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
Any event | 159(48.5) | 9(2.7) | 80(48.8) | 5(3.0) |
Asthenia | 59(18.0) | 1(0.3) | 21(12.8) | 0 |
Pain | 27(8.2) | 1(0.3) | 15(9.1) | 0 |
Bone pain | 41(12.5) | 0 | 14(8.5) | 0 |
Back pain | 16(4.1) | 0 | 15(9.1) | 1(0.6) |
Limb pain | 10(3.0) | 1(0.3) | 10(6.1) | 0 |
Nausea | 25(7.6) | 0 | 13(7.9) | 0 |
Alanine aminotransferase increased | 31(9.5) | 1(0.3) | 12(7.3) | 0 |
Aspartate aminotransferase increased | 20(6.1) | 1(0.3) | 7(4.3) | 0 |