Research Article
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 |
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