Table 2.

Overview of reported AEs^a, relationship to drug and intensity

	EMD 525797														Placebo (Pooled) N = 18
	35 mg		100 mg		250 mg		500 mg		1000 mg		1500 mg		Overall
	N = 6		N = 6		N = 6		N = 6		N = 6		N = 7		N = 37
	n (%)	E	n (%)	E	n (%)	E	n (%)	E	n (%)	E	n (%)	E	n (%)	E	n (%)	E
Any AE	4 (67)	6	4 (67)	6	3 (50)	5	6 (100)	18	5 (83)	17	5 (71)	9	27 (73)	61	14 (78)	35
Relationship to drug
Likely	3 (50)	5	3 (50)	3	1 (17)	2	4 (67)	13	4 (67)	12	2 (29)	3	17 (46)	38	12 (67)	21
Not likely	1 (17)	1	3 (50)	3	3 (50)	3	5 (83)	5	3 (50)	5	4 (57)	6	19 (51)	23	8 (44)	14
Intensity
Mild	1 (17)	1	3 (50)	3	2 (33)	2	5 (83)	6	4 (67)	6	3 (43)	4	18 (49)	22	9 (50)	15
Moderate	4 (67)	4b	3 (50)	3	1 (17)	3	4 (67)	11	4 (67)	11	4 (57)	5	20 (54)	37	13 (72)	19
Severe	-	-	-	-	-	-	1 (17)	1	-	-	-	-	1 (3)	1	-	-

^aSubjects could report more than 1 AE

^bOf 2 observed AEs “creatinine renal clearance decreased,” only 1 was counted

AE, adverse event; E, number of events; N/n, number of subjects reporting AEs