Influence of acetaminophen on liver function: A cohort study using a real world database

Not Applicable

• Conditions: Drug-induced liver injury

• Registration Number: JPRN-UMIN000045199
• Lead Sponsor: AYUMI PHARMACEUTICAL CO., LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-20
• Study Completion: 2023-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 34684

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with virus hepatitis (B15-B19), alcoholic hepatitis (K70), or a hepatic disorder name defined as a clinical outcome

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rates of hepatic disease and ALT > male 126U/L,female 69U/L(JCOG>3*ULN). Non-inferiority of acetaminophen to NSAIDs with respect to risk of hepatotoxicity will be considered to be demonstrated if the 95% confidence interval of rate ratio below the non-inferiority margin of 1.39. This margin was set using a fixed-margin method based on a meta-analysis of randomized placebo-controlled trials.