1. Woodworth T, Furst DE, Alten R, Bingham CO 3rd, Yocum D, Sloan V, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol. 2007;34:1401–14.
2. Ioannidis JP, Evans SJ, Gotzsche PC, O’Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the consort statement. Ann Intern Med. 2004;141:781–8.
3. PhUSE. Analysis and displays associated with adverse events. 2017.
https://www.phuse.eu/documents//workinggroups/deliverables/adverse-events-white-paper-version-10-03-feb-17-11796-19835.pdf
. Accessed Sept 2019.
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Post-approval safety data management: definitions and standards for expedited reporting. 2003.
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf
. Accessed Sept 2019.
5. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 2017.
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
. Accessed Sept 2019.