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

Table 3

Summary of the major adverse events.

Patient no.	Sex	Tumor type	Symptoms	Concurrently administered medication	Causality	Safety trial
One pack/day
Patient no. 6	Male	Bladder cancer	Lower abdominal discomfort (G1)	Betaxolol hydrochloride, nitrendipine	Possible	Complete
Patient no. 11	Male	Prostate cancer	Hand tremor and dizziness when given concomitantly with cold medication (G1)	Cold medication	Possible	Incomplete
Patient no. 19	Male	Prostate cancer	Nausea (G1)	Glimepiride, allopurinol, mecobalamin	Probable	Incomplete
Patient no. 55	Female	Ovarian cancer	Elevated AST (G1) and total bilirubin (G1), urticaria (G3)	—	Definite	Incomplete
Two packs/day
Patient no. 27	Male	Prostate cancer	Diarrhea (G1)	Allopurinol, losartan potassium	Possible	Complete
Patient no. 32	Male	Prostate cancer	Occurrence of other cancer (G4)		Unrelated	Incomplete
Patient no. 34	Male	Prostate cancer	Nausea (G1)	Nicardipine, trichlormethiazide, carteolol	Possible	Incomplete
Three packs/day
Patient no. 4	Female	Cervical cancer	Obstruction, gastrointestinal (G2)	—	Possible	Incomplete
Patient no. 38	Male	Prostate cancer	Lower abdominal discomfort (G1)	—	Probable	Incomplete