Table 4.

Summary of AEs

		Bilirubin Level at Diagnosis of VOD/SOS*
n (%)	All VOD/SOS Post-HCT (N = 803)	<2 mg/dL (n = 181)	≥2 mg/dL (n = 613)
Treatment-emergent AEs	565 (70)	111 (61)	452 (74)
Serious AEs	421 (52)	62 (34)	357 (58)
AEs of interest
Hemorrhage	229 (29)	37 (20)	191 (31)
Hypotension	87 (11)	8 (4)	79 (13)
Treatment-related AEs	167 (21)	34 (19)	132 (22)
Leading to discontinuation	100 (13)	20 (11)	79 (13)
Leading to death	23 (3)	5 (3)	18 (3)
Treatment-related AEs (>2%)†
Pulmonary hemorrhage	35 (4)	7 (4)	28 (5)
Gastrointestinal hemorrhage	25 (3)	3 (2)	22 (4)
Epistaxis	18 (2)	3 (2)	15 (2)
Hemorrhage	7 (1)	3 (2)	4 (1)
Hypotension	11 (1)	1 (1)	10 (2)

^*Of the 803 post-HCT patients in the T-IND, 9 patients had missing data on bilirubin level at diagnosis.

^†Treatment-related AEs occurring in >2% of either bilirubin category.