. Author manuscript; available in PMC: 2016 Sep 1.

Published in final edited form as: Food Chem Toxicol. 2015 Jun 5;83:26–35. doi: 10.1016/j.fct.2015.05.019

Table 5.

ALT Elevation Events^a by Severity in GTE and Placebo Groups

		Total Events (No.)			# Participants (%) with Adverse Events^b

		GTE	Placebo	Total	GTE (n=538)	Placebo (n=537)	P-value

		53	4	57	36 (6.7)	4 (0.7)	<0.001

Grade (Severity)^c	1	39	4	43	22 (4.1)	4 (0.7)	<0.001
	2	7	0	7	7 (1.3)	0 (0)	0.02^d
	3	6	0	6	6 (1.1)	0 (0)	0.03^d
	4	1	0	1	1 (0.2)	0 (0)	1.00^d

ALT elevation listed in “Investigations’ system category in Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Data presented as number of participants (% total participants). For participants who reported multiple ALT elevations, the most severe elevation per subject is presented.

Grade: 1=mild; 2=moderate; 3=severe; 4=life-threatening.

Based on Fisher’s exact test.

Abbreviation: GTE, green tea extract.