Study: NCT02437162

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 116 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 116 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 116 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 116 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 5 affected / 116 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 6 affected / 116 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 3 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 26 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 26 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 44 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 44 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA Version 20.0
Frequency: 1 affected / 44 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA Version 20.0
Frequency: 1 affected / 44 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA Version 20.0,
Frequency: 1 affected / 44 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 44 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 44 at risk

Adverse event: Ankylosing spondylitis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 44 at risk

Adverse event: Ocular hypertension
Serious: yes
Organ System: Eye disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 43 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 43 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 116 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 116 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 116 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 3 affected / 116 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 9 affected / 116 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 8 affected / 116 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 8 affected / 116 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA Version 20.0
Frequency: 3 affected / 116 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 21 at risk

Adverse event: Back injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA Version 20.0
Frequency: 1 affected / 21 at risk

Adverse event: Benign salivary gland neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA Version 20.0
Frequency: 1 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 21 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 21 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 2 affected / 21 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 3 affected / 21 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 114 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA Version 20.0
Frequency: 1 affected / 114 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 114 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 6 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 4 affected / 114 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 11 affected / 114 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 6 affected / 114 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: MedDRA Version 20.0
Frequency: 3 affected / 114 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 114 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 14 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA Version 20.0
Frequency: 1 affected / 14 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 14 at risk

Adverse event: Ankylosing spondylitis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 14 at risk

Adverse event: Fasciitis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA Version 20.0
Frequency: 1 affected / 14 at risk