TABLE 4.
TEAEs during the PROTECT VIII extension study
| TEAEs |
On‐demand (N = 14) |
Prophylaxis (N = 107) |
Total (N = 121) |
|---|---|---|---|
| Any AE, n (%) | 10 (71.4) | 86 (80.4) | 96 (79.3) |
| Mild | 1 (7.1) | 26 (24.3) | 27 (22.3) |
| Moderate | 5 (35.7) | 36 (33.6) | 41 (33.9) |
| Severe | 4 (28.6) | 24 (22.4) | 28 (23.1) |
| Any study drug related AE | 0 (0.0) | 10 (9.3) | 10 (8.3) |
| Mild | 0 (0.0) | 5 (4.7) | 5 (4.1) |
| Moderate | 0 (0.0) | 4 (3.7) | 4 (3.3) |
| Severe | 0 (0.0) | 1 (0.9) | 1 (0.8) |
| Any AE related to procedures as per protocol | 0 (0.0) | 3 (2.8) | 3 (2.5) |
| AE‐related deaths, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any SAE, n (%) | 2 (14.3) | 34 (31.8) | 36 (29.8) |
| Any study drug related SAE | 0 (0.0) | 2 (1.9) a | 2 (1.7) |
| Discontinuation due to AE, n (%) | 0 (0.0) | 2 (1.9) | 2 (1.7) |
| Discontinuation due to SAE, n (%) | 0 (0.0) | 2 (1.9) | 2 (1.7) |
Abbreviations: AE, adverse events; SAE, serious adverse events; TEAE, treatment emergent adverse events.
a
Elevated liver function tests in one patient and severe migratory back pain (two cases) in another patient, both treated with the twice weekly prophylaxis regimen, resulting in discontinuation of the study drug.