Table 2.

Summary of overall frequency and type of patient-initiated violations by arm.

Patient-initiated violations by arm			Arm 1 (N=56), n (%)	Arm 2 (N=33), n (%)	All (N=89), n (%)
Total patient-initiated violations in the analysis population
	0		16 (28)	10 (30)	26 (29)
	1		15 (26)	9 (27)	24 (27)
	2		12 (21)	4 (12)	16 (18)
	3		9 (16)	4 (12)	13 (14)
	4		1 (1)	3 (9)	4 (4)
	5		—a	1 (3)	1 (1)
	6		1 (1)	1 (3)	2 (2)
	7		1 (1)	1 (3)	2 (2)
	11		1 (1)	—	1 (1)
	All		56 (100)	33 (100)	89 (100)
Summary of type of patient-initiated violations in the analysis population
	Incomplete medication diary
		1	5 (8)	1 (3)	6 (6)
		3	2 (3)	2 (6)	4 (4)
		4	—	1 (3)	1 (1)
		Total	7 (12)	4 (12)	11 (12)
	Failure to return medication diary to visit
		1	4 (7)	1 (3)	5 (5)
		3	2 (3)	2 (6)	4 (4)
		4	—	1 (3)	1 (1)
		Total	6 (10)	4 (12)	10 (11)
	Failure to return leftover medication to visit
		1	3 (5)	2 (6)	5 (5)
		3	8 (14)	2 (6)	10 (11)
		4	—	1 (3)	1 (1)
		Total	11 (19)	5 (15)	16 (18)
	Failure to notify study team of interim cycle adverse event
		1	3 (5)	2 (6)	5 (5)
		3	5 (8)	—	5 (5)
		4	2 (3)	—	2 (2)
		Total	10 (17)	2 (6)	12 (13)
	Failure to notify study team of interim emergency department visit
		1	1 (1)	—	1 (1)
		3	1 (1)	—	1 (1)
		Total	2 (3)	0 (0)	2 (2)
	Number of improper doses
		6	—	1 (3)	1 (1)
		12	1 (1)	—	1 (1)
		Total	1 (1)	1 (3)	2 (2)
	Number of improper self con-medication administration
		1	3 (5)	—	3 (3)
		3	—	1 (3)	1 (1)
		12	—	1 (3)	1 (1)
		Total	3 (5)	2 (6)	5 (5)
	Number of missed appointments
		1	—	1 (3)	1 (1)
		5	1 (1)	—	1 (1)
		12	—	1 (3)	1 (1)
		Total	1 (1)	2 (6)	3 (3)
	Number of missed doses
		1	3 (5)	2 (6)	5 (5)
		3	5 (8)	3 (9)	8 (9)
		6	3 (5)	—	3 (3)
		15	1 (1)	—	1 (1)
		Total	12 (21)	5 (15)	17 (19)
	Number of wrong doses
		1	2 (3)	—	2 (2)
		3	2 (3)	1 (3)	3 (3)
		Total	4 (7)	1 (3)	5 (5)
	Number of doses self-administered at the wrong time
		1	—	1 (3)	1 (1)
		3	2 (3)	2 (6)	4 (4)
		4	—	1 (3)	1 (1)
		Total	2 (3)	4 (12)	6 (6)

^aNot applicable.