Cardiovascular Safety Profile of Romosozumab: A Pharmacovigilance Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS)

. 2021 Apr 13;10(8):1660. doi: 10.3390/jcm10081660

	Event of interest	All other events
Romosozumab	a	b
All other drugs in FAERS	c	d
Information component (IC): $I C = l o g_{2} ((N_{o b s} + 0.5) / (N_{e x p} + 0.5))$ $N_{o b s} = a$ $N_{e x p} = ((a + b) * (a + c)) / (a + b + c + d)$ $I C_{025} = I C - 3.3 * {(N_{o b s} + 0.5)}^{- \frac{1}{2}} - 2 * {(N_{o b s} + 0.5)}^{- 3 / 2}$	Reporting odds ratio (ROR): $R O R = \frac{a / b}{c / d}$ $S E_{\ln R O R} = \sqrt{\frac{1}{a} + \frac{1}{b} + \frac{1}{c} + \frac{1}{d}}$ $95 % C I_{R O R} = R O R * e^{(† 1.96 * S E_{(\ln R O R)})}$
Equation 1. Formulas for disproportionality measures. Abbreviations: FAERS: Food and Drug Administration Adverse Event Reporting System, obs: observed, exp: expected, CI: confidence interaval.