Study: NCT03208985

Adverse event: Exposure during pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 783 at risk

Adverse event: Spontaneous abortions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 783 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 783 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 783 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 783 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 783 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 783 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 783 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 783 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 783 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 783 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 783 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 783 at risk

Adverse event: Influenza
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 783 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 783 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 783 at risk

Adverse event: Rash
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 783 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 783 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 783 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 783 at risk

Adverse event: Maternal exposure during breast feeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 783 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 783 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 783 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 783 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 783 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 783 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 783 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 783 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 783 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 783 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 783 at risk

Adverse event: Trichomoniasis
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 783 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 783 at risk

Adverse event: Vomiting
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 783 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 783 at risk