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The Incidence of Urticaria, Angioedema, and Type I Hypersensitivity Reactions with Fibrinolytic Agents in Thailand Using Health Product Vigilance Center Database

Not Applicable
Completed
Conditions
The aim of study was to analyze the incidence of urticaria angioedema and type I hypersensitivity reactions from fibrinolytic agents in various indications
anaphylaxis&#44
hypotension&#44
streptokinase&#44
tenecteplase&#44
tissue plasminogen activator
Registration Number
TCTR20191030004
Lead Sponsor
Faculty of Pharmacy, Silpakorn University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
284
Inclusion Criteria

All reports of urticaria, angioedema, or type I hypersensitivity reactions caused due to streptokinase, alteplase, and TNK were enrolled, and any reports described as “unlikely” based on Naranjo probability scale was excluded. Terms specified in the spontaneous reporting system according to the WHO adverse reaction terminology (WHO-ART) were used for identifying the reactions

Exclusion Criteria

No data about important

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of allergy 5 years Incidence
Secondary Outcome Measures
NameTimeMethod
/A N/A N/A
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