Phase I Clinical Study of the Dietary Supplement, Agaricus blazei Murill, in Cancer Patients in Remission

Table 2

The definition of a causal relationship between the study and the adverse event.

Variable	Definition
Unrelated	The event is clearly not related to the investigational agent
	*A causal relationship is biologically implausible
Possible	The event may be related to the investigational agent
	*An alternative explanation for the adverse event is present
	For example concurrent administered medication, invasive surgical procedure
Probable	The event is likely to be related to the investigational agent
	*A temporal relationship between the study and the onset of the adverse event is present
	For example recurrence of symptom by readministration
	*An alternative explanation for the adverse event is not present
Definite	The event is clearly related to the investigational agent
	*A causal relationship is biologically explicable