Table 3.

Grade 3 to 5 Adverse Events

Adverse Event	Arm 1 AUC = 16K No. (%)	Arm 2 AUC = 20K No. (%)	P value
No of patients	49	48
Primary graft failure (Grade 4)	1 (2)	0	1.00
HEMATOLOGIC	3 (6)	2 (4)	1.00
Grade 3 Red cell aplasia #	2 (4)	2 (4)
Grade 3 Autoimmune hemolytic anemia	1 (2)	0
CARDIAC	1 (2)	0	1.00
Grade 3 Congestive heart failure	1 (2)	0
HEPATIC	5 (10)	6 (13)	0.76
Grade 3 Hyperbilirubinemia*	3 (6)	3 (6)
Grade 4 Hyperbilirubinemia*	0	2 (4)
Grade 3 Elevation of alkaline phosphatase	2 (4)	0
Grade 3 Transaminitis	0	1 (2)
INFECTIONS**	24 (49)	25 (52)	0.84
Grade 3 Viral infection	5 (10)	5 (10)
Grade 3 Fungal infection	1 (2)	1 (2)
Grade 3 Bacterial infection	12 (24)	14 (29)
Grade 4 Bacterial infection	2 (4)	2 (4)
Grade 5 Bacterial infection	4 (8)	3 (6)
Grade 3 Presumed viral encephalopathy	2 (4)	0	0.49
Grade 3 Neutropenic fever***	8 (16)	16 (33)	0.06
Grade 3 Cellulitis	1 (2)	0	1.00
PULMONARY	3 (6)	11 (23)	0.02
Grade 3 Engraftment syndrome	0	2 (4)
Grade 3 IPS	2 (4)	8 (17)
Grade 4 IPS	0	1 (2)
Grade 5 Pneumonia	1 (2)	0
GASTROINTESTINAL	3 (6)	10 (21)	0.04
Grade 3 Mucositis	3 (6)	9 (19)
Grade 3 Neutropenic colitis	0	1 (2)
RENAL	1 (2)	1 (2)	1.00
Grade 3 Renal insufficiency	1 (2)	1 (2)

^#due to major ABO incompatibility

^*Asymptomatic hyperbilirubinemia; resolved spontaneously. No cases of venoocclusive disease.

^**Organism documented.

^***Cultures negative; no obvious focus of infection.

Abbreviations: AUC, area under the curve; IPS, idiopathic pneumonia syndrome