Preferred Label : Adverse Event of Special Interest;
NCIt related terms : AESI; Adverse Events of Special Interest;
NCIt definition : An event (serious or non-serious) of scientific and medical concern specific to the
sponsor's product or program, for which ongoing monitoring and rapid communication
by the investigator to the sponsor can be appropriate. (ICH);
Alternative definition : ICH: A description of the processes and procedures used to define, measure, confirm,
and report the occurrence of adverse events that are of special interest to the specific
trial, or state not applicable.;
Codes from synonyms : ICH M11-Section 9;
Origin ID : C217358;
concept_is_in_subset
