Table 1.
Events | Pharmacovigilance reporting rateb |
---|---|
Renal failure | 34 (2.80) |
Myocardial infarction | 33 (2.70) |
Cardiac arrest | 26 (2.14) |
Cardiac failurec | 15 (1.23) |
Cardiac disorders | 10 (0.82) |
Congestive cardiac failured | 10 (0.82) |
Cerebrovascular accident | 9 (0.74) |
End-stage renal disease | 9 (0.74) |
Data are presented as n (%)
PY patient-years
aReported in ≥ 0.5% of 1214 deaths. Of the 1214 reported deaths in the patiromer global pharmacovigilance database, 80% had no reported cause
bReporting 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
cIncludes verbatim terms of heart failure, cardiac failure, cardiac failure (not otherwise specified), cardiac function failure, and cardiac failure aggravated
dIncludes verbatim terms of congestive heart failure, congestive cardiac failure, cardiac failure congestive, and cardiac failure congestive aggravated