The POP Trial Investigators read with interest this letter from Dr. Karlsson [1] regarding the results of our Phase 1 trial [2]. We agree that all safety information from this trial is important for our planning of future trials.
The frequency of gastrointestinal adverse events and serious adverse events in the 4 different treatment groups is already presented in Supplementary Table 2 [2]. These adverse events were nausea, vomiting or abdominal pain – all symptoms that are common after a paracetamol overdose treated with acetylcysteine.
No patient in this trial developed diarrhoea.
References
- 1.Karlsson J.O.G. Gastrointestinal AEs seen in the POP trial due to SOD mimetic activity of calmangafodipir? EBioMedicine. 2019 doi: 10.1016/j.ebiom.2019.08.038. https://www.ebiomedicine.com/article/S2352-3964(19)30556-0/fulltext [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Morrison E.E., Oatey K., Gallagher B. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12h regimen of N-acetylcysteine for paracetamol overdose (POP trial) EBioMedicine. 2019;46:423–430. doi: 10.1016/j.ebiom.2019.07.013. [DOI] [PMC free article] [PubMed] [Google Scholar]