Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 9:06 AM
Study NCT ID:
NCT04311359
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2020-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacovigilance Study of Brain Oedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001929', 'term': 'Brain Edema'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9524}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of drugs associated with Brain Oedema', 'timeFrame': 'Cases reported to the FAERS database since inception till 31/03/2019', 'description': 'The search includes MedDRA (v-22) Preferred Term, "Brain Oedema (MedDRA code: 10048962) for the identification of all Brain Oedema case reports and drugs.'}, {'measure': 'Detection of signals of Brain Oedema', 'timeFrame': 'Cases reported to the FAERS database since inception till 31/03/2019', 'description': 'Signal detection using disproportionality analysis'}], 'secondaryOutcomes': [{'measure': 'Stratification of new signals with respect to age', 'timeFrame': 'Cases reported to the FAERS database since inception till 31/03/2019'}, {'measure': 'Stratification of new signals with respect to gender', 'timeFrame': 'Cases reported to the FAERS database since inception till 31/03/2019'}, {'measure': 'Trends of Brain Oedema reports in FAERS database', 'timeFrame': 'Cases reported to the FAERS database since inception till 31/03/2019'}, {'measure': 'Trends of Brain Oedema reports in Google searches', 'timeFrame': 'Cases reported to the FAERS database since inception till 31/03/2019'}, {'measure': 'Description of the population of patients having Brain Oedema', 'timeFrame': 'Cases reported to the FAERS database since inception till 31/03/2019'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Edema', 'Brain Edema Caused by Drugs']}, 'descriptionModule': {'briefSummary': 'Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).', 'detailedDescription': 'Brain oedema is a serious neurological condition, as it possesses a significant impact on the functional abilities of an individual by causing irreversible brain damage and potentiates the risk of mortality. Apart from a number of medical conditions causing brain oedema, evidence suggests the association of various drugs with brain oedema. Therefore, this study aims to provide a comprehensive disproportionality analysis of the drug-induced brain oedema reports in the FAERS database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presented with brain oedema treated for any disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brain Oedema cases reported in the FAERS database till 31/03/2019\n* Adverse event reported was included using the MedDRA term: Brain Oedema\n\nExclusion Criteria:\n\n* Drugs with less than 19 brain oedema reports'}, 'identificationModule': {'nctId': 'NCT04311359', 'briefTitle': 'A Pharmacovigilance Study of Brain Oedema', 'organization': {'class': 'OTHER', 'fullName': 'University of Peshawar'}, 'officialTitle': 'A Pharmacovigilance Study of Brain Oedema in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms', 'orgStudyIdInfo': {'id': 'PV-BO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group/Cohort', 'description': 'Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019', 'interventionNames': ['Drug: Drugs, Generic']}], 'interventions': [{'name': 'Drugs, Generic', 'type': 'DRUG', 'description': 'All drugs having 19 or more Brain Oedema cases reported to the FAERS database', 'armGroupLabels': ['Group/Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'University of Peshawar', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Peshawar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Pharmacy', 'investigatorFullName': 'Mohammad Ismail', 'investigatorAffiliation': 'University of Peshawar'}}}}