Table 3.
Occurrence of adverse events during the study
| Pegademase N = 7 |
Elapegademase N = 7 |
|
|---|---|---|
| Treatment-emergent event, n (%) | 6 (85.7) | 7 (100.0) |
| Maximum severity of AE, n (%) | ||
| Mild | 4 (57.1) | 1 (14.3) |
| Moderate | 2 (28.6) | 3 (42.9) |
| Severe | 0 (0.0) | 3 (42.9) |
| Treatment-related event, n (%) | 1 (14.3)a | 2 (28.6)b |
| Maximum severity of treatment-related AE, n (%) | ||
| Mild | 1 (14.3) | 1 (14.3) |
| Moderate | 0 (0.0) | 0 (0.0) |
| Severe | 0 (0.0) | 1 (14.3) |
| Patients with any SAE, n (%) | 0 (0.0) | 4 (57.1) |
| Patients discontinued treatment due to AE, n (%) | 0 (0.0) | 1 (14.3)c |
| Nonserious AE, n (%) | 6 (85.7) | 7 (100.0) |
aPatient 1 had an abnormally low hemoglobulin, possibly related to study medication
bPatient 5 had mild injection-site discomfort/sensitivity and Patient 1 had 2 incidents of injection-site pain (1 moderate and 1 severe) that led to study withdrawal
cInjection-site pain (severe)
AE, adverse event; SAE, serious adverse event