COSTART – Knowledge and References

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Clinical Trials with Anti-p53 DNA, OL(1)p53, in Patients with Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Published in Eric Wickstrom, Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors, 2020

Statistical evaluation of the data was conducted by an outside agency to ensure an unbiased perspective. National Cancer Institute (NCI) common toxicity criteria were employed which assigns a grade of 0, 1, 2, 3, or 4 in 22 clinical categories. A grade of 0 means no toxicity or within normal limits and 1, 2, 3 and 4 represent increasing toxicity or severity. Adverse experiences (AEs) are coded according to the COSTART system. Finally the frequency of clinical observations were evaluated for the 10 day intravenous infusion period, and for 28 days post dosing.

Safety of naproxen compared with placebo, ibuprofen and acetaminophen: a pooled analysis of eight multiple-dose, short-term, randomized controlled studies

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Journal Information

Published in Current Medical Research and Opinion, 2019

Kizito Kyeremateng, Emanuel Troullos, Alberto Paredes-Diaz

All AEs reported during the individual studies were mapped to preferred terms using COSTART and MedDRA. All preferred terms were mapped after data entry to system organ classes by MedDRA version 20.1, to ensure unique mapping. Multiple AEs with the same preferred terms were counted only once per patient, using the worst-case approach for severity (mild, moderate, severe) and relationship to study drug (probably not, unknown, probably).