Table 3.
Summary of TEAEs in any treatment group during the DBTP
| TEAEs (n (%) of patients) | Placebo i.v. Q4W (n = 16) | Evinacumab 15 mg kg−1 i.v. Q4W (n = 35) |
|---|---|---|
| Patients with at least one TEAE | 11 (68.8) | 25 (71.4) |
| Patients with at least one serious TEAE | 3 (18.8) | 4 (11.4) |
| Patients with at least one TEAE resulting in discontinuation of treatment | 0 | 2 (5.7) |
| Patients with any TEAE resulting in death | 0 | 0 |
| TEAEs occurring in ≥2 patients in any group | ||
| Abdominal pain | 2 (12.5) | 5 (14.3) |
| Headache | 1 (6.3) | 4 (11.4) |
| Constipation | 0 | 3 (8.6) |
| AP | 2 (12.5) | 3 (8.6) |
| Abdominal discomfort | 0 | 2 (5.7) |
| Alanine aminotransferase increased | 0 | 2 (5.7) |
| Aspartate aminotransferase increased | 0 | 2 (5.7) |
| Back pain | 0 | 2 (5.7) |
| Contusion | 0 | 2 (5.7) |
| Dizziness | 0 | 2 (5.7) |
| Herpes zoster | 0 | 2 (5.7) |
| Nasopharyngitis | 1 (6.3) | 2 (5.7) |
| Sinusitis | 0 | 2 (5.7) |
| Type 2 diabetes mellitus | 1 (6.3) | 2 (5.7) |