Study: NCT02817841

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 1864 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1864 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1864 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1864 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1864 at risk

Adverse event: Bacterial pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1864 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1864 at risk

Adverse event: Infection parasitic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1864 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Hepatic haematoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1864 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1864 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1864 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1864 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1864 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 1864 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 1864 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 1864 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 1864 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 1864 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 1864 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 1864 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 1864 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 1864 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 86 affected / 1864 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 66 affected / 1864 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 54 affected / 1864 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 41 affected / 1864 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 39 affected / 1864 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 26 affected / 1864 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 20 affected / 1864 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 1864 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 1864 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 1864 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 1864 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 1864 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 1864 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 45 affected / 1864 at risk

Adverse event: Mood swings
Serious: no
Organ System: Psychiatric disorders
Frequency: 38 affected / 1864 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 1864 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 1864 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 1864 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 1864 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 1864 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 1864 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 1864 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 62 affected / 1864 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 1864 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 1864 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 42 affected / 1864 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1864 at risk