Table 3.

Most common^a gastrointestinal adverse events in the patiromer clinical trial program and corresponding rates in the global pharmacovigilance database

Nonserious AEs	Clinical trial programb	Pharmacovigilance reporting ratec
Constipation	48 (7.2)	3105 (6.90)
Diarrhea	32 (4.8)	1566 (3.48)
Nausea	15 (2.3)	755 (1.67)
Abdominal discomfort	13 (2.0)	647 (1.43)
Flatulence	13 (2.0)	568 (1.26)

Data are presented as n (%)

AE adverse events, PY patient-years

^aOccurring in ≥ 2% of patients in the safety population of the patiromer clinical trial program

^bN = 666

^cReporting rate = (# events/# PY [45,000]) × 100 = % of events per 100 PYs. Between January 2016 and September 2019, there were an estimated 45,000 PYs of exposure to patiromer in the global pharmacovigilance database