Study: NCT02200770

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 56 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 56 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Hepatitis A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Neuroborreliosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 56 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 56 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Breast cancer female
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 56 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Lumbosacral radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Neuromyelitis optica spectrum disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Uraemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 56 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pickwickian syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Drug reaction with eosinophilia and syst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 56 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 56 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 56 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 56 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 56 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 56 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 56 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 56 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 56 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 56 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 56 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 56 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 56 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 56 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 56 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 56 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 56 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 56 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 56 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 56 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 56 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 56 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 56 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 56 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 56 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 56 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 56 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 56 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 56 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 56 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 56 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 56 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 56 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 56 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 56 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 56 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 56 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 174 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Renal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 174 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 174 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Peripheral nerve palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 174 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 174 at risk

Adverse event: Steroid withdrawal syndrome
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 174 at risk

Adverse event: Blindness unilateral
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 174 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 174 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 174 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 174 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Central nervous system infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Chorioretinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 174 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Progressive multifocal leukoencephalopat
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 174 at risk

Adverse event: Burns third degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 174 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 174 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 174 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 174 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 174 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 174 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Connective tissue disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 174 at risk

Adverse event: Myelitis transverse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Neuromyelitis optica spectrum disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 174 at risk

Adverse event: Post cardiac arrest syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 174 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 174 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 174 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 174 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 174 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 174 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 174 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 174 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 174 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 174 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 174 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 174 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 174 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 174 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 174 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 174 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 174 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 174 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 174 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 174 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 174 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 174 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 174 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 174 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 174 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 174 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 174 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 174 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 174 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 174 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 174 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 174 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 174 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 174 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 174 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 174 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 174 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 174 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 174 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 174 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 174 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 174 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 174 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 174 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 174 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 174 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 174 at risk