MedDRA-preferred terms that were considered potentially prolactin-related AEs were amenorrhea (RLAT: 1.8%), erectile dysfunction (Flu-Dec: 2.3%), galactorrhea (Fpt-Dec: 2.9%; Flu-Dec: 2.3%), loss of libido (Zuc-Dec: 2.4%) and sexual dysfunction (Hal-Dec: 1.9%; RLAT: 1.8%). Here, PRL is linked to amenorrhea.