AVP and Increased circulating prolactin concentration: The specific ADRs related to this SOC, classified at the MedDRA PT level for PP were hyperprolactinaemia (n = 226; 88.6%), followed by inappropriate antidiuretic hormone secretion (n = 9; 3.5%), hypothyroidism (n = 4; 1.6%), thyroid disorder (n = 3; 1.2%), and diabetes insipidus (n = 2; 0.8%).