Work

Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting

Year: 2019

Type: article

Abstract: Absolute neutrophil counts are used to assess eligibility and safety during clinical trials but the toxicity grading scale used can affect enrollment and reporting of adverse events. During a trial investigating a parenteral rotavirus vaccine in South Africa, we excluded otherwise healthy infants without HIV infection from participation owing to neutropenia. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02109484.

Source: The Journal of Pediatrics X

DOI: 10.1016/j.ympdx.2019.100005

Authors: Anthonet Koen, Lisa Jose, Shabir A. Madhi, Alan Fix, Stanley Cryz, Michelle J. Groome

Institutions: University of the Witwatersrand, Respiratory and Meningeal Pathogens Research Unit, National Research Foundation, Program for Appropriate Technology in Health

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,651