Disproportionality; Pharmacovigilance; Signal detection; Time to onset; Vaccine safety
Indexed keywords
INFLUENZA VACCINE;
ROTAVIRUS VACCINE;
ADVERSE OUTCOME;
ARTICLE;
BAYES THEOREM;
DRUG LABELING;
DRUG SAFETY;
DRUG SURVEILLANCE PROGRAM;
GASTROENTERITIS;
HUMAN;
IMMUNIZATION;
KOLMOGOROV SMIRNOV STATISTIC;
PRIORITY JOURNAL;
ROTAVIRUS INFECTION;
SENSITIVITY AND SPECIFICITY;
SIGNAL DETECTION;
STATISTICAL ANALYSIS;
TIME TO ONSET;
Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting
Jacobsen SJ, Ackerson BK. Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting. Vaccine 2009; 27: 4656-4661.
Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf 2002; 25(6): 381-392.
European Commission, Enterprise and Industry directorate-general. A guideline on summary of product characteristics; September . (last accessed 30 September 2011).
European Commission, Enterprise and Industry directorate-general. A guideline on summary of product characteristics; September 2009. (last accessed 30 September 2011).
(2009)
11
70350129173
Statistics: analysis and presentation of safety data
Talbott J, Waller P (eds). John Wiley & Sons: Chichester, England
Evans SJW. Statistics: analysis and presentation of safety data. In Stephens' Detection of New Adverse Drug Reactions. Talbott J, Waller P (eds). John Wiley & Sons: Chichester, England, 2004; 301-328.