Study: NCT02842736

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 242 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 242 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 242 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 242 at risk

Adverse event: Chronic Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 242 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 242 at risk

Adverse event: Uterine spasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 242 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 242 at risk

Adverse event: Endometritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Vulvovaginitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 242 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 242 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 242 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 242 at risk

Adverse event: Uterine tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 242 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 242 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 242 at risk

Adverse event: Adenomyosis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 2 affected / 242 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Endometritis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 2 affected / 242 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 15 affected / 242 at risk

Adverse event: Pelvic cramping
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 2 affected / 242 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 4 affected / 242 at risk

Adverse event: Polycystic ovarian disease
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Pos- coital bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Pregnancy; uterine
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Pregnancy; uterine terminated
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Right breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 2 affected / 242 at risk

Adverse event: Uterine prolapse Stage 2
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 1 affected / 242 at risk

Adverse event: Vaginal infection and/or discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 11 affected / 242 at risk

Adverse event: Vaginal/vulvar pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Gynecologic adverse event reported after Month 12
Frequency: 2 affected / 242 at risk