Study: NCT03170362

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 18 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 966 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 345 affected / 966 at risk

Adverse event: Sexual side effects
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 409 affected / 966 at risk

Adverse event: GI distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 272 affected / 966 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 272 affected / 966 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 130 affected / 966 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 966 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 18 affected / 978 at risk

Adverse event: Imprisonment
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 978 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 978 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 370 affected / 978 at risk

Adverse event: Sexual side effects
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 402 affected / 978 at risk

Adverse event: GI distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 235 affected / 978 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 235 affected / 978 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 108 affected / 978 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 978 at risk