Table 4.

Adverse events during the six-week study period stratified by dose level.

	All dose levels N=34	Dose 1 (0.125 mg/kg/day) N=6	Dose 2 (0.25 mg/kg/day) N=7	Dose 3 (0.5 mg/kg/day) N=3	Dose 4 (0.75 mg/kg/day) N=18	P value
Total adverse events, N	87	11	14	6	56
Subjects who experienced
≥1 adverse event, N (%)	24(70.6)	4 (66.7)	4 (57.1)	2 (66.7)	14 (77.8)	0.754
≥2 adverse events, N (%)	20(58.8)	2(33.3)	3 (42.9)	2 (66.7)	13 (72.2)	0.263
AE study drug relationship
Probably related to study	3 (3.5)	0 (0)	1 (7.1)	0 (0)	2 (3.6)	>0.99
drug, N (%)
Possibly related to study drug, N (%)	6 (6.9)	0 (0)	0 (0)	0 (0)	6 (10.7)	0.16
Serious adverse events, N	4	0	0	1	3
Number (%) of subjects who	4 (11.8)	0 (0)	0 (0)	1 (33.3)	3 (16.7)	0.369
experienced SAE
Recrudescent fever†	2	0	0	1	1
Worsening CAA†	2	0	0	0	2

^†These events led to prolonged hospitalization and thus qualified as an SAE