Table 4.

Adverse effects in the safety population

	MTX group (n = 78)				Control group (n = 78)
	Grade 1–2	Grade 3	Grade 4	Grade 5	Grade 1–2	Grade 3	Grade 4	Grade 5
Platelet decreaseda	11(14%)	6(8%)	4(5%)	0	10(13%)	2(3%)	4(5%)	0
Neutrophil decreaseda	18(23%)	13(16%)	0	0	21(27%)	5(6%)	0	0
Cytomegalovirus infection	50 (64%)	3 (4%)	0	0	48 (62%)	1(1%)	0	0
Cardiac	5(6%)	0	0	0	4(5%)	0	0	1(1%)
Gastrointestinalb	3(4%)	0	0	0	3(4%)	2(3%)	1(1%)	0
Hepatobiliary/pancreatic disorders	0	0	0	0	2(3%)	1(1%)	0	0
Investigationsb	17(22%)	3(4%)	0	0	18(23%)	4(5%)	1(1%)	1(1%)
Metabolism and nutrition disorders	14(18%)	2(3%)	0	0	13(17%)	4(5%)	0	0
Nervous system disorders	0	0	0	0	0	0	0	1(1%)
Renal/genitourinary	10(13%)	0	0	0	13(17%)	1(1%)	0	1(1%)
Vascular	2(3%)	5(6%)	0	0	2(3%)	4(5%)	0	0
Infectionsc	8(10%)	1(1%)	0	2(3%)	8(10%)	0	0	2(3%)
Secondary malignancyd	-	1(1%)	0	0	-	0	0	0
mucositis	16(21%)	2(3%)	0	0	22(28%)	0	0	0

Grade 1–2 adverse events in more than 10% of patients and all grade 3–5 adverse events were recorded

^aincluded the patients with platelet and neutrophil counts both decreased

^bexcluded the patients with GVHD

^cexcluded the patients with cytomegalovirus viremia and Epstein Barr virus viremia

^dsecondary malignancy was post-transplant lymphoproliferative disease