Table 2.

Counts of adverse events and System Organ Class (SOC) that were found significant based on both PRR and ROR values and their respective Confidence Intervals.

Source	Adverse events		SOC
	All	Suspect	All	Suspect
FAERS	3437	883	635	326
CVAR	3354	2600	390	340
Common	248	52	45	14

CVAR: Canada Vigilance Adverse Reaction; FAERS: FDA’s Adverse Event Reporting System; PRR: Proportional Reporting Ratio; ROR: Reporting Odds Ratio; SOC: System Organ Class. Timeframe: FAERS:2004-2016 and CVAR: 1965-2017.