Table 5.

Adverse Events and Serious Adverse Events by Arm

	Patients, n (%)
Adverse Event	Acetaminophen Arm	Control Arm	P Value
Fever	6 (3)	10 (5)	.18
Rigors	5 (3)	3 (2)	.51
Neurological
Headache	12 (7)	8 (4)	.36
Dizziness	14 (8)	10 (5)	.80
Retro-orbital pain	2 (1)	1 (0.5)	.60
Confusion	5 (3)	2 (1)	.27
Gastrointestinal
Nausea	7 (4)	6 (3)	.87
Vomiting	6 (3)	3 (2)	.33
Loss of appetite	17 (9)	16 (9)	.96
Abdominal pain	6 (3)	7 (4)	.64
Diarrhea	3 (2)	1 (0.5)	.34
Skin, rash or itch	7 (4)	2 (1)	.09
Respiratory
Cough	3 (2)	6 (3)	.33
Difficulty breathing	1 (0.5)	4 (2)	.19
Joint pain	10 (6)	8 (4)	.70
Muscle ache	10(6)	8 (4)	.70
Spontaneous bleeding	2 (1)	0 (0)	.17
Bruising	3 (2)	1 (0.5)	.34