Safety
ADVERSE EVENT, UPPER RESPIRATORY TRACT INFECTION, ADVERSE EVENT, UTI, URINARY TRACT INFECTION, CHRONIC IDIOPATHIC CONSTIPATION
The safety analysis population included 2,627 patients (3 mg of plecanatide [n = 875], 6 mg of plecanatide [n = 877], and placebo [n = 875]). The subgroup analyses revealed no new safety issues with plecanatide in any specific subgroup, and the AE profiles were not affected by demographic variables (Tables Adverse event profile in patients with CIC subgrouped by ageAE, adverse event; CIC, chronic idiopathic constipation; URTI, upper respiratory tract infection; UTI, urinary tract infection.AEs, occurring in ≥1.0% of patients in any subgroup and with any treatment. Ordered by percentage frequency in overall plecanatide 3 mg group and then alphabetical.Adverse event profile in patients with CIC subgrouped by race/ethnicity or sex/genderAE, adverse event; CIC, chronic idiopathic constipation; URTI, upper respiratory tract infection; UTI, urinary tract infection.AEs, occurring in ≥1.0% of patients in any subgroup and with any treatment. Ordered by percentage frequency in overall plecanatide 3 mg group and then alphabetical.Adverse event profile in patients with CIC subgrouped by BMIAE, adverse event; BMI, body mass index; CIC, chronic idiopathic constipation; URTI, upper respiratory tract infection; UTI, urinary tract infection.AEs, occurring in ≥1.0% of patients in any subgroup and with any treatment. Ordered by percentage frequency in overall plecanatide 3 mg group and then alphabetical.