Table 5.
Summary of Adverse Events – SS
| LZM003 - Reference Drug (N = 24) |
Reference Drug - LZM003 (N = 24) |
P valuea | |||||
|---|---|---|---|---|---|---|---|
| Frequency | Cases | Incidence | Frequency | Cases | Incidence | ||
| AE | 44 | 21 | 87.5 | 35 | 16 | 66.7 | 0.1681 |
| TEAE | 44 | 21 | 87.5 | 35 | 16 | 66.7 | 0.1681 |
| Drug-related TEAE | 21 | 11 | 45.8 | 19 | 11 | 45.8 | 1.0000 |
Notes: aP value was a comparison of the incidence of LZM003 – reference drug group and reference drug – LZM003 group based on Fisher exact test. None of TEAE level 3 and above; STEAE; drug-related STEAE; deaths due to TEAE; discontinuations due to TEAE; discontinuations due to drug-related TEAE; drug suspension and resumption due to TEAE and drug withdrawal due to TEAE happened in this trial.
Abbreviations: SS, safety set; AE, adverse event; TEAE, treatment-emergent adverse event; STEAE, serious treatment-emergent adverse event.