Rate of severe cutaneous adverse reactions due to first line Anti-tuberculosis drugs, Health Product Vigilance Center database; Food and Drug Administration, Ministry of Public Health

Not Applicable

• Conditions: severe cutaneous adverse reactionsSCARscutaneous adversed reactionsantituberculosisfirst line antituberculosis drugsSJSTENDRESSAGEP; severe cutaneous adverse reactions; SCARs; cutaneous adversed reactions; antituberculosis; first line antituberculosis drugs; SJS; TEN; DRESS; AGEP

• Registration Number: TCTR20180812003
• Lead Sponsor: Tipsiri Chaikong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-12
• Study Completion: 2019-02-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

1. reports that the culprit drugs was Isoniazid, Rifampin, Pyrazinamide, Ethambutol, Streptomycin
2. reports that adverse reactions was Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug reaction with eosinophilia and Systemic symptoms/ Drug-induced hypersensitivity syndrome (DRESS/ DIHS), Acute Generalized Exanthematous Pustulosis (AGEP) or the rash that was reported to be serious rash

Exclusion Criteria

The report that these data incompleted; report date, gender, age, drug allergy history, culprit drug name, start date, stop date, ADRs occurrence date, ADRs, causality relationship, seriousness of reactions, patient result from SCARs

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of severe cutaneous adverse reaction 5 months Descriptive Statistics (frequency of severe cutaneous adverse reaction per 1000 patients by using PS

Secondary Outcome Measures

Name	Time	Method
relationship between outcome and type of severe cutaneous adverse reactions 5 months chi square, logistic regression(95% confidence interval, odd ratios), Significant alpha 0.05