Study: NCT03875729

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 111 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 111 at risk

Adverse event: Device related bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 111 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 111 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 111 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 111 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 111 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 111 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 111 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 111 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 111 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 111 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 111 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 111 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 111 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 111 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 111 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 111 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 111 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 111 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 111 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 111 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 111 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 111 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 111 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 111 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 111 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 111 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 111 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 111 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 111 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 111 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 111 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 111 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 111 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 111 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 111 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 81 affected / 111 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 111 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 111 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 217 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 217 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 217 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 217 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 217 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 217 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 217 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 217 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 217 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 217 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 53 affected / 217 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 217 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 19 affected / 217 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 16 affected / 217 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 217 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 217 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 217 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 217 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 73 affected / 217 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 53 affected / 217 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 217 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 217 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 217 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 217 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 217 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 217 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 50 affected / 217 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 217 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 217 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 217 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 92 affected / 217 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 217 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 217 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 217 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 217 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 86 affected / 217 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 217 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 217 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 217 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 217 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 217 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 217 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 217 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 217 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 217 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 217 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 217 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 151 affected / 217 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 217 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 217 at risk