Comparison of Prospective and Retrospective Methods of a Tigecycline Post-Marketing Surveillance Study in the Safety Outcomes of Patients with Complicated Skin Structure Infection, Complicated Intraabdominal Infection and Community-Acquired Pneumonia.

ABSTRACT:

Introduction

Safety data can be collected through prospective and retrospective methods during post-marketing surveillance (PMS). This study aimed to compare prospective and retrospective methods in terms of examining safety data from PMS of tigecycline.

Methods

This PMS study was an open-label, noncomparative, observational, noninterventional and multicenter study of patients who received tigecycline for infections. From July 2007 to April 2015, 3172 patients were included in this study, of which 738 were enrolled prospectively and 2434 retrospectively. To reduce selection bias, demographic and baseline characteristics were adjusted using 1:2 propensity score matching.

Results

After propensity score matching, data from 1446 patients were analyzed. The incidences of a

SUBMITTER: Chi W 

PROVIDER: S-EPMC7955005 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature