Study: NCT03284424

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 159 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 159 at risk

Adverse event: Lymphocytic hypophysitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 159 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Abdominal wall haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Duodenal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 159 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Dermo-hypodermitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Fungal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Infestation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 159 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 159 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 159 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 159 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Osteoradionecrosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Radiation necrosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 159 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Groin pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 159 at risk

Adverse event: Infected neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 159 at risk

Adverse event: Lentigo maligna
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Neoplasm recurrence
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Neuroendocrine carcinoma of the skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 159 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 159 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cranial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Autoimmune nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Prerenal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Giant cell arteritis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Superior vena cava occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 159 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 14 affected / 159 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 159 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 159 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 159 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 159 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 159 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 159 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 159 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 17 affected / 159 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 159 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 159 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 159 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 159 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 159 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 159 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 159 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 159 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 159 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 159 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 159 at risk

Adverse event: Hyperchloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 159 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 159 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 159 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 159 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 159 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 159 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 159 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 159 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 159 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 159 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 159 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 159 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 159 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 159 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 159 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 159 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 159 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 159 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Scrotal cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperchloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk