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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Group | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of IS in subjects aged < 12 months | 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 | Between January 2005 and April 2011 (6 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of IS cases hospitalized more than once among subjects aged < 12 months. | Between January 2005 and April 2011 (6 years) | |
| Occurrence of IS cases by calendar months and year among subjects aged < 12 months | Between January 2005 and April 2011 (6 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Children aged <12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D007443 | Intussusception |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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|
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |