Study: NCT03725852

Adverse event: Gastrointestinal viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 45 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Mucous stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 45 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Gingival abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 45 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Idiopathic pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Interstitial lung disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 45 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 45 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 45 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 45 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Brain natriuretic peptide increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 45 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 45 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 45 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Normocytic anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 45 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hepatic mass
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 45 at risk

Adverse event: Renal pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 45 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 45 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 23 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk

Adverse event: Erythema migrans
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Oral fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Immune thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Panophthalmitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 23 at risk