•Electronic text string search of database for “possibly
suicide-related” events (and
blinded selection of events of interest)
–Search of preferred terms for the following 2 text
strings: “suic” or “overdos”
•Asked for separate listing of events coded as accidental
overdoses
–Search of verbatim (i.e., investigator) terms for
following 15 text strings:
“attempt; cut; gas; hang; hung; jump; mutilat; overdos; self damag; self harm; self inflict; self injur; shoot;
slash; suic”
•Permitted exclusions for events that represented obvious
false positives (e.g., “gas” in
“gastrointestinal”)
•Blinded review of narratives for any deaths and serious
adverse events (regulatory
definition)
•Blinded selection from among “suicide-related events” a
subset of events that could be
considered “suicide attempts” (self harm)
•Sponsors asked to provide narrative for each patient
identified as having one or
more potential events