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| Name | Class |
|---|---|
| PHARMO Institute for Drug Outcome Research | UNKNOWN |
The purpose of this study is
Time Perspective: Other = Retrospective analysis of prospectively collected data Number of Anticipated Subjects: All subjects dispensed esomeprazole, other PPIs or H2-receptor antagonists for the first time during the study period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All first time users of esomeprazole | |||
| All first time users of other PPIs | |||
| All first time users of H2-receptor antagonists |
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| Measure | Description | Time Frame |
|---|---|---|
| Drug utilization: Description of patient characteristics and drug usage | Study period 3 years | |
| Follow-up of safety outcomes: First occurrence of hospitalized angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include all children aged 0 to 18 years receiving a first dispension of acid suppressing drugs recorded in the PHARMO RLS database between September 2008 and October 2011. Subjects will be followed-up for at least 18 month. First review of study outcomes including chart reviews is estimated to start in August 2011.
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| Name | Affiliation | Role |
|---|---|---|
| Ron M.C. Herings, PhD | PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands | Principal Investigator |
| Leanne M.A. Houweling, MSc | PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserach Site | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29149805 | Derived | Houben E, Johansson S, Nagy P, Penning-van Beest FJA, Kuipers EJ, Herings RMC. Observational cohort study: safety outcomes in children using proton pump inhibitors or histamine-2 receptor antagonists. Curr Med Res Opin. 2018 Apr;34(4):577-583. doi: 10.1080/03007995.2017.1407302. Epub 2017 Nov 24. | |
| 28562108 | Derived |
| Label | URL |
|---|---|
| D9612N00016 Children Study report synopsis Final redacted | View source |
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| Ruigomez A, Kool-Houweling LMA, Garcia Rodriguez LA, Penning-van Beest FJA, Herings RMC. Characteristics of children and adolescents first prescribed proton pump inhibitors or histamine-2-receptor antagonists: an observational cohort study. Curr Med Res Opin. 2017 Dec;33(12):2251-2259. doi: 10.1080/03007995.2017.1336083. Epub 2017 Jun 9. |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D005759 | Gastroenteritis |
| D005183 | Failure to Thrive |
| D012640 | Seizures |
| C564356 | Acute Tubulointerstitial Nephritis |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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