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Serious Adverse Drug Reaction and Their Preventability

NCT02888834 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2016-09-05

No results posted yet for this study

Summary

Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%.

Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.

Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

Conditions

  • Adverse Drug Reaction

Interventions

OTHER

Adverse drug reaction

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-05-31
Completion
2013-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02888834 on ClinicalTrials.gov