Table 3 Summary of Adverse Events (AEs)
Endpoint | LMWF-5A KL grade 4 (n = 144) | LMWF-5A KL grade 2–4 (n = 1076) | Saline KL grade 2–4 (n = 931) |
|---|---|---|---|
One or more AE | 49 (34.0%) | 381 (35.4%) | 386 (41.5%) |
One or more related AE | 10 (6.9%) | 11 (1.0%) | 19 (2.0%) |
AE by severitya | |||
mild | 25 (17.4%) | 264 (24.5%) | 253 (27.2%) |
moderate | 22 (15.3%) | 162 (15.1%) | 190 (20.4%) |
severe | 2 (1.4%) | 35 (3.3%) | 32 (3.4%) |
Serious AE (SAE) | 0 (0%) | 15 (1.4%) | 20 (2.1%) |
AE leading to withdrawal | 0 (0%) | 0 (0%) | 0 (0%) |
AE resulting in death | 0 (0%) | 0 (0%) | 0 (0%) |