CompletedNot Applicable

A Pharmacovigilance Study of Brain Oedema

Pakistan9,524 participantsStarted 2019-05-20

Plain-language summary

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).

Who can participate

SexALL

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Inclusion Criteria: * Brain Oedema cases reported in the FAERS database till 31/03/2019 * Adverse event reported was included using the MedDRA term: Brain Oedema Exclusion Criteria: * Drugs with less than 19 brain oedema reports

What they're measuring

Identification of drugs associated with Brain Oedema

Timeframe: Cases reported to the FAERS database since inception till 31/03/2019

Detection of signals of Brain Oedema

Timeframe: Cases reported to the FAERS database since inception till 31/03/2019

Trial details

NCT IDNCT04311359

SponsorUniversity of Peshawar

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-11-10

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