MedDRA System Organ Class/Preferred Term Overall Group A Group B
Dapivirine Vaginal Ring (N=36) Placebo Vaginal Ring (N=12) Dapivirine Vaginal Ring (N=18) Placebo Vaginal Ring (N=6) Dapivirine Vaginal Ring (N=18) Placebo Vaginal Ring (N=6)
  n (%) n (%) n (%) n (%) n (%) n (%)
Participants with one or more events 32 (88.9) 11 (91.7) 17 (94.4) 5 (83.3) 15 (83.3) 6 (100)
All Local TEAEs:            
Reproductive system and breast disorders
Dysmenorrhoea 0 1 (8.3) 0 0 0 1 (16.7)
Metrorrhagia 21 (58.3) 9 (75.0) 11 (61.1) 5 (83.3) 10 (55.6) 4 (66.7)
     Vaginal discharge 3 (8.3) 2 (16.7) 1 (5.6) 1 (16.7) 2 (11.1) 1 (16.7)
     Vaginal pain 1 (2.8) 0 1 (5.6) 0 0 0
Vulvovaginal discomfort 4 (11.1) 1 (8.3) 2 (11.1) 0 2 (11.1) 1 (16.7)
Vulvovaginal dryness 1 (2.8) 0 1 (5.6) 0 0 0
Vulvovaginal pruritus 2 (5.6) 0 1 (5.6) 0 1 (5.6) 0
Infections and Infestations
     Chlamydial infection 0 1 (8.3) 0 0 0 1 (16.7)
     Vaginal candidiasis 1 (2.8) 0 1 (5.6) 0 0 0
Other TEAEs Occurring in 10% or More of the Participants in any for the Dapivirine Arms:
Gastrointestinal disorders            
     Abdominal pain 4 (11.1) 5 (41.7) 2 (11.1) 2 (33.3) 2 (11.1) 3 (50.0)
     Abdominal pain lower 4 (11.1) 4 (33.3) 3 (16.7) 1 (16.7) 1 (5.6) 3 (50.0)
     Dyspepsia 4 (11.1) 1 (8.3) 4 (22.2) 0 0 1 (16.7)
     Nausea 5 (13.9) 1 (8.3) 3 (16.7) 0 2 (11.1) 1 (16.7)
General disorders and administration site conditions
     Influenza like illness 3 (8.3) 0 2 (11.1) 0 1 (5.6) 0
Musculoskeletal and connective tissue disorders
     Back pain 2 (5.6) 0 2 (11.1) 0 0 0
     Neck pain 3 (8.3) 0 3 (16.7) 0 0 0
Nervous system disorders            
     Headache 14 (38.9) 6 (50.0) 7 (38.9) 3 (50.0) 7 (38.9) 3 (50.0)
Presyncope 2 (5.6) 0 0 0 2 (11.1) 0
     Somnolence 2 (5.6) 0 2 (11.1) 0 0 0
Renal and urinary disorders            
     Dysuria 2 (5.6) 1 (8.3) 2 (11.1) 1 (16.7) 0 0
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain 3 (8.3) 3 (25.0) 1 (5.6) 1 (16.7) 2 (11.1) 2 (33.3)
Skin and subcutaneous tissue disorders
     Rash 2 (5.6) 0 0 0 2 (11.1) 0
MedDRA=Medical Dictionary for Regulatory Activities; TEAE=Treatment-emergent Adverse Event
Table 3: Incidence of Treatment Emergent Adverse Events.