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) |