Infections and inflammatory diseases as risk factors for venous thrombosis

YIGV Tichelaar, HJC Kluin-Nelemans… - Thrombosis and …, 2012 - thieme-connect.com
Inflammation and venous thrombosis are intertwined. Only in the recent 15 years clinical
epidemiological studies have focussed on inflammatory or infectious diseases as risk factors …

Signal detection and monitoring based on longitudinal healthcare data

M Suling, I Pigeot - Pharmaceutics, 2012 - mdpi.com
Post-marketing detection and surveillance of potential safety hazards are crucial tasks in
pharmacovigilance. To uncover such safety risks, a wide set of techniques has been …

When should case‐only designs be used for safety monitoring of medical products?

M Maclure, B Fireman, JC Nelson… - … and drug safety, 2012 - Wiley Online Library
Purpose To assess case‐only designs for surveillance with administrative databases.
Methods We reviewed literature on two designs that are observational analogs to crossover …

Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico

FR Velázquez, RE Colindres, C Grajales… - The Pediatric …, 2012 - journals.lww.com
Background: Mexico initiated mass vaccination with the attenuated human rotavirus vaccine
(Rotarix) in 2006. This postlicensure study aimed to assess any potential temporal …

Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety …

SK Greene, M Rett, ES Weintraub, L Li… - American journal of …, 2012 - academic.oup.com
An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976
swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines …

Safety of zoster vaccine in adults from a large managed‐care cohort: a Vaccine Safety Datalink study

HF Tseng, A Liu, L Sy, SM Marcy… - Journal of internal …, 2012 - Wiley Online Library
Tseng HF, Liu A, Sy L, Marcy SM, Fireman B, Weintraub E, Baggs J, Weinmann S, Baxter R,
Nordin J, Daley MF, Jackson L, Jacobsen SJ, for the Vaccine Safety Datalink (VSD) Team …

Design considerations in an active medical product safety monitoring system

JJ Gagne, B Fireman, PB Ryan… - … and drug safety, 2012 - Wiley Online Library
Active medical product monitoring systems, such as the Sentinel System, will utilize
electronic healthcare data captured during routine health care. Safety signals that arise from …

Biologically plausible and evidence-based risk intervals in immunization safety research

A Rowhani-Rahbar, NP Klein, CL Dekker, KM Edwards… - Vaccine, 2012 - Elsevier
In immunization safety research, individuals are considered at risk for the development of
certain adverse events following immunization (AEFI) within a specific period of time referred …

The risk of Guillain–Barré syndrome associated with influenza A (H1N1) 2009 monovalent vaccine and 2009–2010 seasonal influenza vaccines: results from self …

JI Tokars, P Lewis, F DeStefano, M Wise… - … and drug safety, 2012 - Wiley Online Library
ABSTRACT Purpose The Centers for Disease Control and Prevention Emerging Infections
Program implemented active, population‐based surveillance for Guillain–Barré syndrome …

Case-only designs in pharmacoepidemiology: a systematic review

S Nordmann, L Biard, P Ravaud, M Esposito-Farèse… - PloS one, 2012 - journals.plos.org
Background Case-only designs have been used since late 1980's. In these, as opposed to
case-control or cohort studies for instance, only cases are required and are self-controlled …