An observational study in Intussusception, sponsored by GlaxoSmithKline. Completed. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2012-10-22.
Sponsored by GlaxoSmithKline · Observational
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged \<12 months after introduction of the Rotarix vaccination in Japan.
31 studies on the registry are indexed under Intussusception; 6 are open to participants now.
This study's enrollment of 54 is below the median of 250 across 15 observational studies indexed under Intussusception.
Browse Intussusception studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children aged \<12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.
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Exclusion Criteria:
Not applicable
Children aged \< 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB).
Other: Data collection
Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.
Occurrence of IS in subjects aged < 12 months
Time frame: Between January 2005 and April 2011 (6 years)
Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan
Time frame: Between January 2005 and April 2011 (6 years)
Number of IS cases hospitalized more than once among subjects aged < 12 months.
Time frame: Between January 2005 and April 2011 (6 years)
Occurrence of IS cases by calendar months and year among subjects aged < 12 months
Time frame: Between January 2005 and April 2011 (6 years)
No study locations are listed for this record.
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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