Table 2.

Serious adverse events reported in the patiromer clinical trial program with a frequency of ≥ 0.5% and corresponding reporting rates in the global pharmacovigilance database

Serious AEsa	Clinical trial programb	Pharmacovigilance reporting ratec
Chronic renal failure	7 (1.1)	0 (0.0)
Sudden death	6 (0.9)	0 (0.0)
Sudden cardiac death	5 (0.8)	2 (0.0)
Acute myocardial infarction	4 (0.6)	3 (0.0)
Myocardial infarction	3 (0.5)	120 (0.2)
Atrial fibrillation	3 (0.5)	45 (0.1)
Cardiac failure	3 (0.5)	45 (0.1)

Data are presented as n (%)

AEs adverse events, PY patient-years

^aOverall, 6% of serious AEs met the criteria of hospitalization

^bSafety population from the patiromer clinical trial program (N = 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