- Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990-2007Wei Hua
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, Rockville, MD 20852 1448, USA
Pediatr Infect Dis J 28:943-7. 2009..A review of RotaTeq (rotavirus vaccine live) clinical trial data revealed higher, though not statistically significantly, KD rates among RotaTeq vaccines than placebo recipients. In June 2007, the RotaTeq label was revised accordingly...
- A simulation study to compare three self-controlled case series approaches: correction for violation of assumption and evaluation of biasWei Hua
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
Pharmacoepidemiol Drug Saf 22:819-25. 2013..In this simulation study, we compared the performance of the standard SCCS approach and two alternative approaches when the event-independent exposure assumption was violated...