Table 2.

Number of Participants with Adverse Events

		TFV 1% gel (topical)		HEC placebo gel (topical)
	TDF (oral)	Single dose	7-day dose	Single dose	7-day dose
Participants enrolled	18	12		6
Participants with one or more AEs (all)
Grade 1: Mild	11 (30)	4 (11)	12 (41)	4 (9)	4 (8)
Grade 2: Moderate	3 (5)	4 (6)	3 (6)	1 (4)	1 (1)
Grade 3: Severe	2 (2)	0	2 (6)	0	0
Participants with gastrointestinal AEs
Grade 1: Mild	7 (15)	4 (6)	12 (34)	3 (5)	1 (5)
Grade 2: Moderate	0	2 (4)	2 (3)	1 (4)	1 (1)
Grade 3: Severe	0	0	2 (5)	0	0
Participant's specific gastrointestinal AEs
Abdominal bloating (G1)	3 (3)	0	4 (8)	0	1 (1)
Abdominal bloating (G2)	0	1 (1)	0	1 (1)	0
Abdominal bloating (G3)	0	0	1 (1)	0	0
Abdominal pain/cramps (G1)	1 (1)	2 (2)	2 (2)	1 (1)	1 (1)
Abdominal pain/cramps (G2)	0	1 (1)	0	1 (1)	1 (1)
Abdominal pain/cramps (G3)	0	0	1 (1)	0	0
Colon polyps (G1)	4 (4)	0	1 (1)	0	0
Constipation (G1)	1 (1)	0	0	0	0
Defecation urgency (G1)	0	0	4 (6)	0	0
Defecation urgency (G2)	0	1 (1)	1 (1)	0	0
Defecation urgency (G3)	0	0	2 (2)	0	0
Diarrhea (G1)	2 (3)	1 (1)	6 (7)	0	0
Diarrhea (G2)	0	0	2 (2)	0	0
Fissure (anal) (G1)	1 (1)	0	0	0	0
Flatulence (G1)	0	0	2 (2)	0	0
Flatulence (G2)	0	1 (1)	0	0	0
Hemorrhoid	0	0	0	1 (1)	0
Loose stool (G1)	0	0	0	1 (1)	0
Loss of appetite (G1)	1 (1)	0	0	0	0
Mucosal red spots (G1)	0	1 (1)	0	2 (2)	0
Nausea (G1)	1 (1)	2 (2)	3 (5)	0	1 (1)
Nausea (G2)	0	0	0	1 (1)	0
Rectal discharge (G1)	0	0	1 (1)	0	0
Rectal pain (G1)	0	0	1 (1)	0	1 (1)
Tenesmus (G1)	0	0	1 (1)	0	1 (1)
Tenesmus (G2)	0	0	0	0	0
Tenesmus (G3)	0	0	1 (1)	0	0
Vomiting (G2)	0	0	0	1 (1)	0

Only AEs following product exposure are reported. Some individuals report more than 1 AE. For convenience all Grade 3 AEs are listed in bold.

AE, adverse event; TDF, tenofovir disoproxil fumarate; TFV, tenofovir; HEC, hydroxyethyl-cellulose.