Table 2.

Adverse events

	Placebo (n = 28)		1-day ART (n = 27)		3-day ART (n = 24)
	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4
Overall AEs	28 (100.0)	15 (53.6)	27 (100.0)	16 (59.3)	24 (100.0)	16 (66.7)
Most common AEs
Neutrophil count decreased	12 (42.9)	9 (32.1)	13 (48.1)	8 (29.6)	16 (66.7)	11 (45.8)
Malaise	17 (60.7)	0 (0.0)	11 (40.7)	0 (0.0)	12 (50.0)	0 (0.0)
Nausea	9 (32.1)	0 (0.0)	12 (44.4)	1 (3.7)	9 (37.5)	0 (0.0)
Inappetence	12 (42.9)	1 (3.6)	8 (29.6)	0 (0.0)	8 (33.3)	0 (0.0)
Dysgeusia	7 (25.0)	0 (0.0)	7 (25.9)	0 (0.0)	8 (33.3)	0 (0.0)
Fatigue	7 (25.0)	1 (3.6)	5 (18.5)	0 (0.0)	8 (33.3)	0 (0.0)
Constipation	6 (21.4)	0 (0.0)	7 (25.9)	0 (0.0)	4 (16.7)	0 (0.0)
Diarrhea	5 (17.9)	0 (0.0)	5 (18.5)	0 (0.0)	5 (20.8)	1 (4.2)
Alopecia	4 (14.3)	0 (0.0)	6 (22.2)	0 (0.0)	2 (8.3)	0 (0.0)
Mucositis oral	3 (10.7)	1 (3.6)	4 (14.8)	0 (0.0)	5 (20.8)	0 (0.0)
White blood cell count decreased	1 (3.6)	0 (0.0)	6 (22.2)	1 (3.7)	3 (12.5)	0 (0.0)
Bleeding AEs	2 (7.1)	0 (0.0)	3 (11.1)	0 (0.0)	6 (25.0)	0 (0.0)
Epistaxis	1 (3.6)	0 (0.0)	2 (7.4)	0 (0.0)	3 (12.5)	0 (0.0)
Implant site hemorrhage	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (8.3)	0 (0.0)
Bronchopulmonary hemorrhage	1 (3.6)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Hematuria	0 (0.0)	0 (0.0)	1 (3.7)	0 (0.0)	0 (0.0)	0 (0.0)
Hyposphagma	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (4.2)	0 (0.0)
Purpura	0 (0.0)	0 (0.0)	1 (3.7)	0 (0.0)	0 (0.0)	0 (0.0)

All data are shown as Nos. (%)

AE adverse event, ART recombinant thrombomodulin