Table 3.

Summary of adverse events

	TDF	Placebo
All adverse events	57/70 (81%)	13/70 (19%)
Grade 1	53/70 (76%)	13/70 (19%)
Grade 2	4/70 (6%)	0
Product or procedure-related genitourinary adverse events	33/70 (47%)	4/70 (6%)
Cervical discharge	2/33 (6%)	0
Cervical ulcer	1/33 (3%)	0
Dyspareunia	1/33 (3%)	0
Postcoital bleeding	1/33 (3%)	0
Vaginal bleeding	1/33 (3%)	0
Vaginal dryness	0	2/4 (50%)
Vaginal discharge*	7/33 (21%)	2/4 (50%)
Vaginal erythema	8/33 (24%)	0
Vaginal itching	1/33 (3%)	0
Vaginal ulcer	11/33 (33%)	0
Common adverse events not related to study product	23/70 (33%)	7/70 (10%)
Gastrointestinal disorders	1/23 (4%)	2/7 (29%)
Respiratory disorders	5/23 (22%)	1/7 (14%)
Psychiatric disorders	1/23 (4%)	0
Reproductive system and breast disorders	3/23 (13%)	2/7 (29%)
Renal and urinary disorders	5/23 (22%)	0
Eye disorders	3/23 (13%)	1/7 (14%)
Nervous system disorders	1/23 (4%)	0
Infections and infestations	4/23 (17%)	0
Musculoskeletal disorders	0	1/7 (14%)
Laboratory abnormalities	1/70 (1%)	2/70 (3%)
Elevated ALT	0	1/70 (1%)
Elevated non-fasting glucose	0	1/70 (1%)
Reduced hemoglobin	1/70 (1%)	0

TDF=tenofovir disoproxil fumarate. ALT=alanine transferase

^*5 were self-reported (3 TDF, 2 Placebo) and not observed on exam