Study: NCT02766023

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 151 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 151 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 151 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 151 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Vaginal bleeding other than menstruation"
Frequency: 38 affected / 151 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Abnormal vaginal discharge"
Frequency: 95 affected / 151 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Abnormal vaginal odor"
Frequency: 80 affected / 151 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Genital itching"
Frequency: 87 affected / 151 at risk

Adverse event: Genital discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Genital burning"
Frequency: 48 affected / 151 at risk

Adverse event: Genital discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "External genital irritation"
Frequency: 62 affected / 151 at risk

Adverse event: Genital swelling
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "External genital swelling"
Frequency: 30 affected / 151 at risk

Adverse event: Genital rash
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Genital rash"
Frequency: 21 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 151 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 151 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited as "Abdominal pain/cramps"
Frequency: 59 affected / 151 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 151 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 151 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Solicited as "Pain/burning with urination"
Frequency: 29 affected / 151 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 151 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 76 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 76 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 76 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Vaginal bleeding other than menstruation"
Frequency: 22 affected / 76 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Abnormal vaginal discharge"
Frequency: 46 affected / 76 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Abnormal vaginal odor"
Frequency: 34 affected / 76 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Genital itching"
Frequency: 34 affected / 76 at risk

Adverse event: Genital discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Genital burning"
Frequency: 19 affected / 76 at risk

Adverse event: Genital discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "External genital irritation"
Frequency: 20 affected / 76 at risk

Adverse event: Genital swelling
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "External genital swelling"
Frequency: 10 affected / 76 at risk

Adverse event: Genital rash
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Solicited as "Genital rash"
Frequency: 7 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 76 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 76 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited as "Abdominal pain/cramps"
Frequency: 27 affected / 76 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 76 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 76 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Solicited as "Pain/burning with urination"
Frequency: 8 affected / 76 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 76 at risk