201889 - Planned analyses related to the Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico.

31/03/2014
01/07/2024
EU PAS number:
EUPAS6110
Study
Finalised

ENCePP Code of conduct

No
Data sources

Data sources (types)

Other

Data sources (types), other

Meta-analysis on the following published studies:Carlin JB, et al. 2013 Clin Infect Dis,57:1427-34.Haber P. et al. 2013 Pediatrics 131, 1042-1049.Patel M et al 2011 N Engl J Med 364, 2283-2292. Shui I.M. et al. 2012 JAMA 307, 598-604.Velázquez et al. (2012) PIDJ 31, 736-744.Weintraub E. et al. 2014 NEJM DOI: 10.1056/NEJMoa1311738 Yih W.K. et al. 2014 NEJM DOI: 10.1056/NEJMoa1303164.
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No
Procedures
No information provided.