Causality Observations

Code Description Comment Version
AW Abatement of event after product withdrawn added v2.3
BE Event recurred after product reintroduced added v2.3
DR Dose response observed added v2.3
EX Alternative explanations for the event available added v2.3
IN Event occurred after product introduced added v2.3
LI Literature reports association of product with event added v2.3
OE Occurrence of event was confirmed by objective evidence added v2.3
OT Other added v2.3
PL Effect observed when patient receives placebo added v2.3
SE Similar events in past for this patient added v2.3
TC Toxic levels of product documented in blood or body fluids added v2.3