Real-life use of delamanid: results from the European post-authorisation safety study.

ABSTRACT:

Background

A post-authorisation safety study (PASS) on delamanid (DLM) was conducted as part of a post-approval commitment to the European Medicines Agency. The aim of this study was to evaluate the use of DLM in a real-life setting, its safety, and treatment outcomes in patients with multidrug-resistant TB (MDR-TB).

Methods

This was a prospective, multicentric, non-interventional study conducted in the European Union. MDR-TB Regimen selection and patient monitoring were conducted in accordance with existing medical practices. Data on the use of DLM, related adverse events, and treatment outcomes were collected for up to 30 months after the first DLM dose. Descriptive summary statistics were used for continuous and categorical variables.

Results

Out of 86 patients, on

SUBMITTER: Schonfeld N 

PROVIDER: S-EPMC11249655 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature