Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

Elizabeth A Chrischilles Joshua J GagneBruce FiremanJennifer NelsonSengwee TohAzadeh ShoaibiMarsha E ReichmanShirley WangMichael NguyenRongmei ZhangRima IzemMargie R GouldingMary Ross SouthworthDavid J GrahamCandace FullerHannah KatcoffTiffany WoodworthCatherine RogersRyan SaligaNancy D LinCheryl N McMahill-WalravenVinit P NairKevin HaynesRyan M Carnahan

Published in: Pharmacoepidemiology and drug safety (2018)

This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety.

Keyphrases

venous thromboembolism
drug administration
pulmonary embolism
public health
randomized controlled trial
clinical trial
study protocol
risk assessment