Study: NCT03191903

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Delirium tremens
Serious: yes
Organ System: General disorders
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Foot operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Inner ear inflammation
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Dermatitis contact
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The AE is resolved without sequelae
Frequency: 1 affected / 251 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Inner ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Lens dislocation
Serious: no
Organ System: Eye disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild and Moderate
Frequency: 3 affected / 251 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 5 affected / 251 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Mild and Moderate
Frequency: 8 affected / 251 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Moderate
Frequency: 2 affected / 251 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Moderate
Frequency: 3 affected / 251 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: General disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Lyme disease
Serious: no
Organ System: Infections and infestations
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 5 affected / 251 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 12 affected / 251 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Severe
Frequency: 1 affected / 251 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Severe
Frequency: 1 affected / 251 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 15 affected / 251 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 14 affected / 251 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Severe
Frequency: 1 affected / 251 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Joint range of motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 3 affected / 251 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 4 affected / 251 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Cervical radiculopathy
Serious: no
Organ System: Nervous system disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Epilepsy
Serious: no
Organ System: Nervous system disorders
Notes: Severe
Frequency: 1 affected / 251 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 31 affected / 251 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Delirium tremens
Serious: no
Organ System: Psychiatric disorders
Notes: Severe
Frequency: 1 affected / 251 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Nervous system disorders
Notes: Severe
Frequency: 1 affected / 251 at risk

Adverse event: Neurosis
Serious: no
Organ System: Psychiatric disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Ovulation pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Severe
Frequency: 1 affected / 251 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Surgical and medical procedures
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Foot operation
Serious: no
Organ System: Surgical and medical procedures
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Glucoma
Serious: no
Organ System: Eye disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild and Moderate
Frequency: 2 affected / 251 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Gastrointestinal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Mild and Moderate
Frequency: 7 affected / 251 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Moderate
Frequency: 3 affected / 251 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 4 affected / 251 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Moderate
Frequency: 3 affected / 251 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 16 affected / 251 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Forearm fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Culture urine positive
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 12 affected / 251 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 5 affected / 251 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 3 affected / 251 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Joint range of motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Joint warmth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 5 affected / 251 at risk

Adverse event: Plantar fascitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 5 affected / 251 at risk

Adverse event: Tenosynovitis stenosans
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 28 affected / 251 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 2 affected / 251 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate
Frequency: 1 affected / 251 at risk

Adverse event: Granuloma skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Hypertention
Serious: no
Organ System: Vascular disorders
Notes: Mild
Frequency: 1 affected / 251 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 2 affected / 74 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Mild and Moderate
Frequency: 1 affected / 74 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: Mild
Frequency: 1 affected / 74 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Notes: Mild
Frequency: 1 affected / 74 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 1 affected / 74 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Mild
Frequency: 6 affected / 74 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 1 affected / 74 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Mild
Frequency: 1 affected / 74 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 2 affected / 74 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Moderate
Frequency: 2 affected / 74 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 74 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 1 affected / 74 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Mild
Frequency: 3 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild
Frequency: 6 affected / 74 at risk