Serious Adverse Drug Reaction and Their Preventability

Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02888834

Acronym

SADR

Enrollment

100

Registered

2016-09-05

Start date

2013-01-31

Completion date

2013-10-31

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Reaction

Keywords

elderly, adverse drug reactions, hospitalized subjects, community-dwelling

Brief 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.

Detailed description

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%. Age itself is not a risk factor for ADRs but is a factor of severity of ADR. According to the World Health Organization (WHO), more than half of all ADRs are considered to be preventable in elderly subjects. They are most often the result of a mistake during the prescription phase, or the monitoring phase, or may be due to poor compliance or inappropriate self-medication. Drug prescription is based on guidelines derived from clinical trial that have not included elderly subject with multiple comorbidities. Data regarding drug safety from clinical trials alone are insufficient, hence the need to continue the monitoring of ADR after drug marketing. 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.

Interventions

OTHERAdverse drug reaction

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged over 65 years * Patients who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne

Design outcomes

Primary

Measure	Time frame
The different type of serious ADR were coded according to Medical Dictionary for Regulatory Activities (MedDRA version 16.0) according to lowest-level terms (LLTs), and then grouped by system organ class (SOC).	9 months

Secondary

Measure	Time frame
Drugs involved in the occurrence of serious ADR	9 months
Evolution were classified as recovered, not yet recovered, recovered with sequelae , death , unknown	9 months
Preventability was assessed by using the preventability French scale.	9 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026