Safety Assessment and Adverse Events Endpoints and adverse events (vomiting, arrythmia, abdominal distention, worsening arterial lactate) were recorded by physicians affiliated with the hospital's clinical research division
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In pediatric patients, the most frequently reported adverse reactions were diarrhea (26%), abdominal pain (23%), vomiting (21%), elevated liver chemistry tests (18%), rash (14%), nausea (13%), pruritus (13%), and headache (12%)