Study: NCT02949830

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Sinusitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Synovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ear haemorrhage
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Swelling of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 16 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 16 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Injection site dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 16 at risk

Adverse event: Injection site indentation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 16 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Injection site urticaria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 16 at risk

Adverse event: Allergy to animal
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oral allergy syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 16 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 16 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Venomous sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Albumin urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Anticoagulation drug level below therapeutic
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Blood homocysteine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Carbon dioxide increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Coronavirus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Creatinine urine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 16 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 16 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 16 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 16 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Prothrombin level increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Urine ketone body present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 16 at risk

Adverse event: Gluten sensitivity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 16 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 16 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 16 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 16 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 16 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 16 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 16 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 16 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oligomenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

Adverse event: Allergic bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 16 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Palmar erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 16 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 16 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Superficial vein prominence
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk