Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Anticonvulsants in Japan

Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Anticonvulsants in Japan - Risk of SJS/TEN Associated with Anticonvulsants in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035031

Enrollment

5400000

Registered

2018-11-27

Start date

2012-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stevens-Johnson syndrome (SJS) Toxic epidermal necrolysis (TEN)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cohort study: Patients who meet the following criteria will be eligible for inclusion in this study: 1. Patients who were newly prescribed an anticonvulsant between April 1, 2012 to December 31, 2017 2. Patients who had an observational period of >90 days after initially being prescribed an anticonvulsant Matched case-control study: Patients who are identified by an algorithm and patients who are selected by risk-set sampling

Exclusion criteria

Exclusion criteria: Cohort study: None Matched case-control study: Patients who did not have an observational period of >180 days prior to the index date

Design outcomes

Primary

Measure	Time frame
Cohort study: Cumulative incidence of SJS/TEN Matched case-control study: Odds ratio for SJS/TEN	—

Countries

Japan

Contacts

Public ContactHisashi Urushihara

Keio University Division of Drug Development and Regulatory Science, Faculty of Pharmacy

urushihara-hs@pha.keio.ac.jp03-5400-2649

Outcome results