Table 4.

Gastrointestinal Adverse Events^a by Symptom, Severity in GTE and Placebo Groups

		Total Events (No.)			# Participants (%) with Adverse Eventsb
		GTE	Placebo	Total	GTE (n=538)	Placebo (n=537)	P-value
Adverse Events	Nausea	69	30	99	55 (10.2)	26 (4.8)	0.001
	Indigestion	49	28	77	38 (7.1)	26 (4.8)	0.12
	Diarrhea	26	47	73	24 (4.5)	43 (8.0)	0.02
	Constipation	19	12	31	17 (3.2)	10 (1.9)	0.17
	Vomiting	10	14	24	10 (1.9)	14 (2.6)	0.41
	Increased gassiness	12	11	23	10 (1.9)	9 (1.7)	0.82
	Abdominal/stomach pain	13	11	24	10 (1.9)	11 (2.1)	0.82
	Bloating	8	7	15	8 (1.5)	7 (1.3)	0.78
	Increased acid reflux	11	8	19	10 (1.9)	8 (1.5)	0.64
	Other	18	16	34	16 (3.0)	13 (2.4)	0.58
Grade (Severity)c	1	203	161	364	128 (23.8)	110 (20.5)	0.19
	2	31	22	53	25 (4.7)	21 (3.9)	0.55
	3	1	1	2	1 (0.19)	1 (0.19)	1.00d
Totals		235	184	419			---

^aAdverse events coded using NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

^bData presented as number of participants (% total participants). For participants who reported multiple gastrointestinal adverse events, the most severe AE per subject, per symptom is presented. Repeated counting occurred for participants reporting more than one GI AE symptom.

^cGrade: 1=mild; 2=moderate; 3=severe.

^dBased on Fisher’s exact test.

Abbreviation: GTE, green tea extract.