Event of Special Interest definition
Event of Special Interest means an event that is of special interest to health authorities, and therefore required to be recorded by Alcon, including use error, abnormal use, product tampering, product counterfeiting and product theft.
Event of Special Interest means any of the following events regardless of its causal relationship to use of the Products: (a) seizure: patient experiences a seizure; (b) pregnancy: a patient receiving therapy with the Products is pregnant or becomes pregnant; (c) worsening illness or suicide attempt/suicidal ideation: a patient is hospitalized due to worsening illness, makes a suicide attempt or the occurrence of a completed suicide; or (d) Device-Device Co-Administration: lf TMS Therapy is administered in a patient with an implanted medical device and a device- device interaction is suspected or occurs.
Event of Special Interest means any of the following events regardless of its causal relationship to use of the Products: (
Examples of Event of Special Interest in a sentence
An Adverse Event of Special Interest (AESI) (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Adverse Event of Special Interest (AESI): An adverse event of special interest is an adverse event (serious or non-serious) of scientific and medical concern specific to the Sponsor’s product or program, regardless of causality, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.