Study: NCT03573297

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 896 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 896 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 896 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 896 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 896 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 896 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 896 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 896 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 896 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 896 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 896 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 896 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 896 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 896 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 896 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 896 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 896 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 105 affected / 896 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 79 affected / 896 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 77 affected / 896 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 145 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 145 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 145 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 145 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 145 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 145 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 145 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 145 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 145 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 145 at risk

Adverse event: Appendiceal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Coronavirus pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Sacral radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 144 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 144 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 144 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 144 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 144 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 144 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 144 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 144 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 147 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 147 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 147 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 147 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 147 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 147 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 147 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 147 at risk