Relationship to FMT	Description
Definitely	Previously known toxicity of product; or an event that follows a reasonable temporal sequence from administration of the study product; that follows a known or expected response pattern to the suspected study product; that is confirmed by stopping or reducing the volume of the study product; and that is not explained by any other reasonable hypothesis.
Probably	An event that follows a reasonable temporal sequence from administration of study product; that follows a known or expected response pattern to the suspected study product; that is confirmed by stopping or reducing the dosage of the study product; and that is unlikely to be explained by the known characteristics of the subject's clinical state or by other interventions.
Possibly	An event that follows a reasonable temporal sequence from administration of study product; that follows a known or expected response pattern to the suspected study product; but that could readily have been produced by a number of other factors.
Unrelated	An event that can be determined with certainty to have no relationship to the study drug.