•Clarification of what electronic searches had actually been conducted
•Complete accounting of the winnowing down of potential events/patients identified by electronic searches to
arrive at events to be blindly
reclassified by outside experts
–Events occurring pre-randomization or post-30 days, and
false positives
•Requested summary narratives for all remaining patients with potential events, including patients classified as having accidental injury or accidental overdose
•Requested narratives for all patients having one or more
serious adverse events (SAE, based
on regulatory definition)
during on-therapy or +30 days period (and not already included in narratives)