Study: NCT02615002

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 1 affected / 88 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Ischaemic cardiomyopathy
Frequency: 1 affected / 88 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory failure
Frequency: 1 affected / 88 at risk

Adverse event: Ischemic Cardiopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Ischemic Cardiopathy
Frequency: 1 affected / 88 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: Syncope
Frequency: 1 affected / 88 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Notes: Abnormal dreams
Frequency: 1 affected / 88 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Somnolence
Frequency: 1 affected / 88 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Sedation
Frequency: 1 affected / 88 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Insomnia
Frequency: 2 affected / 88 at risk

Adverse event: Initial insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Initial insomnia
Frequency: 2 affected / 88 at risk

Adverse event: Disturbance in sexual arousal
Serious: no
Organ System: Psychiatric disorders
Notes: Disturbance in sexual arousal
Frequency: 1 affected / 88 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Notes: Hallucination
Frequency: 1 affected / 88 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinusitis
Frequency: 1 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 1 affected / 88 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 1 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 1 affected / 88 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Duodenal ulcer
Frequency: 1 affected / 88 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Duodenitis
Frequency: 1 affected / 88 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastritis erosive
Frequency: 1 affected / 88 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal haemorrhage
Frequency: 1 affected / 88 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory failure
Frequency: 1 affected / 88 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Humerus Fracture
Frequency: 1 affected / 88 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Bradycardia
Frequency: 1 affected / 88 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardio-respiratory Arrest
Frequency: 1 affected / 88 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anaemia
Frequency: 1 affected / 88 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 1 affected / 88 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 3 affected / 88 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Notes: Abnormal dreams
Frequency: 1 affected / 88 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Somnolence
Frequency: 1 affected / 88 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 2 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhoea
Frequency: 1 affected / 88 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Notes: Large intestine polyp
Frequency: 1 affected / 88 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distension
Frequency: 1 affected / 88 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrooesophageal reflux
Frequency: 1 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis
Frequency: 2 affected / 88 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection
Frequency: 1 affected / 88 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 1 affected / 88 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Colitis
Frequency: 1 affected / 87 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Cervix carcinoma
Frequency: 1 affected / 87 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Uterine cancer
Frequency: 1 affected / 87 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Acute myocardial infarction
Frequency: 1 affected / 87 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Femur Fracture
Frequency: 1 affected / 87 at risk

Adverse event: Multi-organ disorder
Serious: yes
Organ System: General disorders
Notes: Multi-organ disorder
Frequency: 1 affected / 87 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 87 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Notes: Abnormal dreams
Frequency: 3 affected / 87 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 1 affected / 87 at risk

Adverse event: Head discomfort
Serious: no
Organ System: Nervous system disorders
Notes: Head discomfort
Frequency: 1 affected / 87 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Notes: Kidney infection
Frequency: 1 affected / 87 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Influenza
Frequency: 1 affected / 87 at risk

Adverse event: Tubo-ovarian abscess
Serious: no
Organ System: Infections and infestations
Notes: Tubo-ovarian abscess
Frequency: 1 affected / 87 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Alopecia
Frequency: 1 affected / 87 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 1 affected / 87 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnoea
Frequency: 1 affected / 87 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oropharyngeal pain
Frequency: 1 affected / 87 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Asthenia
Frequency: 1 affected / 87 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 2 affected / 105 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Kidney Infection
Frequency: 1 affected / 105 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Head Injury
Frequency: 1 affected / 105 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subdural haematoma
Frequency: 1 affected / 105 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant melanoma in situMalignant melanoma in situ
Frequency: 1 affected / 105 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Squamous cell carcinoma of skin
Frequency: 1 affected / 105 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Notes: Transient ischaemic attack
Frequency: 1 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 8 affected / 105 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Notes: Abnormal dreams
Frequency: 2 affected / 105 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 4 affected / 105 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Somnolence
Frequency: 2 affected / 105 at risk

Adverse event: Head discomfort
Serious: no
Organ System: Nervous system disorders
Notes: Head discomfort
Frequency: 1 affected / 105 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Notes: Hypersomnia
Frequency: 1 affected / 105 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Insomnia
Frequency: 1 affected / 105 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: Agitation
Frequency: 2 affected / 105 at risk

Adverse event: Disorientation
Serious: no
Organ System: Psychiatric disorders
Notes: Disorientation
Frequency: 1 affected / 105 at risk

Adverse event: Libido increased
Serious: no
Organ System: Psychiatric disorders
Notes: Libido increased
Frequency: 1 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea
Frequency: 3 affected / 105 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 3 affected / 105 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhoea
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain
Frequency: 1 affected / 105 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dry mouth
Frequency: 1 affected / 105 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dyspepsia
Frequency: 1 affected / 105 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Nasopharyngitis
Frequency: 1 affected / 105 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Notes: Kidney infection
Frequency: 1 affected / 105 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Sinusitis
Frequency: 1 affected / 105 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection
Frequency: 1 affected / 105 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Notes: Staphylococcal infection
Frequency: 1 affected / 105 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Alopecia
Frequency: 1 affected / 105 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dry skin
Frequency: 1 affected / 105 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 2 affected / 105 at risk