Table 4.

Adverse reactions and events

	Expected	Serious	Total sample	Arm 1		Arm 2
				Study completed	Drop-out	Study completed	Drop-out
Adverse reactions
Allergic reaction, rash	Yes	No	3	0	1	1	1
Headache	Yes	No	3	1	1	0	1
Tachycardia, bradycardia	Yes	No	2	1	0	1	0
Hypotension, vasodilation, syncope, edema	Yes	No	2	0	0	0	2
Nausea, constipation, diarrhea, flatulence	Yes	No	3	0	0	1	2
Hypertension, agitation	No	No	1	0	1	0	0
Total adverse reactions			14	2	3	3	6
Trial drug decreased due to adverse reaction			1	0	0	1	0
Withdrawn due to adverse reaction			4	0	1	0	3
Adverse events
Cerebral hemorrhage	No	Yes	1	0	1	0	0
Incidental carcinoma diagnosis	No	Yes	3	0	0	3	0
Varicella zoster virus infection relapse	No	No	1	1	0	0	0
Total adverse events			5	1	1	3	0
Trial drug decreased due to adverse event			0	0	0	0	0
Withdrawn due to adverse event			1	0	1	0	0