Adverse events of clinical interest
renal disorder, urinary incontinence, cholelithiasis, nephrolithiasis, dysuria, UTI, hematuria, pollakiuria, interstitial/ulcerative cystitis, hepatic adverse
CHOLECYSTITIS, URINARY TRACT INFECTIONS, RENAL DISORDER, ADVERSE EVENTS, EVENT, URINARY INCONTINENCE, CHOLELITHIASIS, NEPHROLITHIASIS, HEMATURIA, UTI, EVENTS
No case of treatment-related interstitial/ulcerative cystitis was identified. Urinary tract infections (UTI) were reported in 153 (13.3%) participants, 65 of whom had more than one episode of UTI (63 of 65 were female, mean age 53.7 years). Other adverse events (incidence ≥1%) related to a renal disorder included dysuria (2.7%), pollakiuria (2.4%), micturition urgency (1.3%), nephrolithiasis (1.3%), hematuria (1.0%), and urinary incontinence (1.0%).A minority (6.3%) of participants experienced 1 or more hepatic adverse events, the most common being gamma glutamyl transferase increased (2.1%), alanine aminotransferase (ALT) increased (1.4%), aspartate aminotransferase increased (1.0%), hepatic enzyme increased (1.0%), and cholelithiasis (1.0%). No participant manifested hepatic enzyme levels of ALT > 3 x upper limit of normal [ULN] and total bilirubin >2 x ULN. Nine hepatic events were considered serious, including 8 events of cholelithiasis and 1 event of cholecystitis, all classified by the site investigator as not related to esketamine.