Adverse event reporting and harms {22}
vomiting, fever, diarrhea, abdominal pain, anemia, STEC, dehydration, HUS, STEC infection
ADVERSE EVENT, EVENT, THROMBOCYTOPENIA, ANEMIA, DEHYDRATION, RENAL INSUFFICIENCY, EVENTS
Study research teams will monitor for the occurrence of AEs throughout the study period. AEs may be reported by the subject or caregivers, discovered by investigator questioning, or detected by the clinical care team through physical examination, laboratory test, or other means. The study period is defined as the initiation of treatment (Day 0) through Day 30 (± 7 days). AEs will be recorded on the AE case report form. The nature of each experience, date and time of onset, course, outcome, severity, and relationship to treatment will be established.Summaries of event rates, intensity, and relationship to study allocation of individual SAEs will be presented by System Organ Class and Preferred Term (MedDRA). MedDRA is a multilingual standardized international medical terminology dictionary used for regulatory communication and evaluation of data pertaining to medicinal products for human use. AE severity will be assessed by the site investigator (Table Adverse events severity scaleThe suspected relationship between study interventions and any AE will be determined by the site investigator. All AEs, including SAEs, will be evaluated as to whether their occurrence was expected or unexpected. An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with the known risks associated with the study intervention or with the underlying medical condition (i.e., STEC infection).The following events and symptoms are routinely expected to occur as part of the natural history of STEC infection, and as such, we a priori determined that they will not be reported as AEs: vomiting, fever, diarrhea, abdominal pain, dehydration, anemia, thrombocytopenia, hospitalization for intravenous rehydration or ongoing oral rehydration therapy, renal insufficiency, HUS, and/or RRT.