Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study.

ABSTRACT:

Objective

To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports.

Design

Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report.

Setting

9 rand

SUBMITTER: Maund E 

PROVIDER: S-EPMC4045315 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature