Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-26 @ 11:39 AM
Study NCT ID:
NCT02888834
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serious Adverse Drug Reaction and Their Preventability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016907', 'term': 'Adverse Drug Reaction Reporting Systems'}], 'ancestors': [{'id': 'D011358', 'term': 'Product Surveillance, Postmarketing'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004346', 'term': 'Drug Information Services'}, {'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-02', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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).', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Drugs involved in the occurrence of serious ADR', 'timeFrame': '9 months'}, {'measure': 'Evolution were classified as "recovered", "not yet recovered", "recovered with sequelae" , "death" , "unknown"', 'timeFrame': '9 months'}, {'measure': 'Preventability was assessed by using the preventability French scale.', 'timeFrame': '9 months'}]}, 'conditionsModule': {'keywords': ['elderly', 'adverse drug reactions', 'hospitalized subjects', 'community-dwelling'], 'conditions': ['Adverse Drug Reaction']}, 'referencesModule': {'references': [{'pmid': '26223243', 'type': 'BACKGROUND', 'citation': 'Kanagaratnam L, Abou Taam M, Heng M, De Boissieu P, Roux MP, Trenque T. [Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029. Epub 2015 Jun 26. French.'}]}, 'descriptionModule': {'briefSummary': '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%.\n\nAim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.\n\nMethods: 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.', 'detailedDescription': '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.\n\nAim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 65 years\n* Patients who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne'}, 'identificationModule': {'nctId': 'NCT02888834', 'acronym': 'SADR', 'briefTitle': 'Serious Adverse Drug Reaction and Their Preventability', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years', 'orgStudyIdInfo': {'id': '2015Ao008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adverse drug reaction', 'description': 'Patients aged over 65 years who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne between January and May 2013 were included in the study.', 'interventionNames': ['Other: Adverse drug reaction']}], 'interventions': [{'name': 'Adverse drug reaction', 'type': 'OTHER', 'armGroupLabels': ['Adverse drug reaction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'state': 'France', 'country': 'France', 'facility': 'Chu de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}