Determinants of adverse event occurrence in children with short stature born small for gestational age treated with growth hormone.

ABSTRACT:

Introduction

Recombinant human growth hormone (rhGH) treatment for short children born small for gestational age (SGA) is effective in improving height outcomes. Determinants of height response to rhGH treatment have been identified using multiple regression analyses. Although adverse events (AEs) associated with treatment have been described, determinants of AE occurrence are not well known.

Methods

This analysis used safety data collected between 2007 and 2018 in an observational, prospective registry study (NCT01578135) including children born SGA across 126 sites in France. AEs were reported by patients or recorded by treating physicians. Univariate and multivariate analyses were performed to identify determinants of occurrence of AEs and serious AEs (SAEs).

Results</

SUBMITTER: Coutant R 

PROVIDER: S-EPMC12672253 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature