Treatment exposure
abdominal pain
ADVERSE EVENT
Treatment exposure during the DBTP was generally consistent across the evinacumab and placebo groups. The mean (s.d.) number of infusions was almost identical for the evinacumab and placebo groups (2.8 (0.6) infusions); the mean (s.d.) duration of study drug exposure was also almost identical between the evinacumab and placebo groups (11.4 (2.4) and 11.4 (2.3) weeks, respectively). Doses were missed by two patients in the placebo group (at week 4 due to hospitalization for abdominal pain (Mean (s.d.) duration of study drug exposure during the SBTP was similar for the DB evinacumab (11.5 (1.4) weeks) and DB placebo (12.1 (1.0) weeks) groups. Evinacumab doses were missed by three patients during the SBTP. Two patients were unable to attend the scheduled visit due to an adverse event; one patient had a visit outside of the window, so the site was advised not to dose the patient and to wait for the next visit (<2 weeks later).