Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-28 @ 8:41 PM
Study NCT ID:
NCT06801158
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2025-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8804863}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reporting of serious AEs', 'timeFrame': '1964 to 2024'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adverse effects', 'oncology', 'vigibase'], 'conditions': ['Adverse Effects of Medical Drugs']}, 'descriptionModule': {'briefSummary': "Importance:\n\nDepression is prevalent among oncology patients and may influence the perception, reporting, and severity of adverse events (AEs) related to cancer therapies. Understanding this association is crucial for optimizing treatment outcomes and improving patient quality of life.\n\nObjective:\n\nTo evaluate the association between depression and the reporting and severity of AEs among oncology patients using data from VigiBase®, the World Health Organization's global pharmacovigilance database.\n\nDesign:\n\nThis pharmacovigilance study employed a case/non-case disproportionality analysis using Individual Case Safety Reports (ICSRs) from 1968 to 2024. Multivariable analyses were conducted to adjust for potential confounders, such as age and sex.\n\nSetting:\n\nThe study utilized data from VigiBase®, a global pharmacovigilance database containing reports from over 120 countries.\n\nParticipants:\n\nICSRs involving antineoplastic or immunomodulating agents were included. Depression was identified through antidepressant use, yielding 428,102 reports for patients on antidepressants and 8,376,761 for those not on antidepressants.\n\nExposure:\n\nOncology patients receiving antidepressant therapy were compared to those not receiving such treatment.\n\nMain Outcome and Measures:\n\nThe primary outcome was the reporting of serious AEs (e.g., hospitalization, life-threatening events). Secondary outcomes included the 20 most frequently reported AEs among oncology patients, with comparisons made between those treated with and without antidepressants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Antidepressants were employed as a proxy for identifying patients experiencing depression. These agents were identified according to the ATC classification for antidepressants (code N06A).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICSRs were limited to those involving liable antineoplastic or immunomodulating agents (per the Anatomical Therapeutic Chemical (ATC) Classification code L; hereafter referred to as antineoplastics)\n\nExclusion Criteria:\n\n* Suspect of duplication'}, 'identificationModule': {'nctId': 'NCT06801158', 'briefTitle': 'Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase', 'orgStudyIdInfo': {'id': 'Pharmacol20241101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with an adverse effect of interest (or with a severity criteria of that AE)', 'interventionNames': ['Drug: use of anticancer drugs in monotherapy or in combination therapy']}, {'label': 'Patients without an adverse effect of interest (or without a severity criteria of that AE)', 'interventionNames': ['Drug: use of anticancer drugs in monotherapy or in combination therapy']}], 'interventions': [{'name': 'use of anticancer drugs in monotherapy or in combination therapy', 'type': 'DRUG', 'description': 'ICSRs involving antineoplastic or immunomodulating agents were included.', 'armGroupLabels': ['Patients with an adverse effect of interest (or with a severity criteria of that AE)', 'Patients without an adverse effect of interest (or without a severity criteria of that AE)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data belong to the WHO Uppsala Monitoring Center'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}