Study: NCT03790111

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 53 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Notes: Bacteremia Klebsiella bacteremia Pneumonia Sepsis Septic shock Urinary tract infection
Frequency: 5 affected / 53 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Cholangitis Hepatobiliary disease Hyperbilirubinemia
Frequency: 3 affected / 53 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Cerebrovascular accident Embolic stroke
Frequency: 3 affected / 53 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Acute myocardial infarction Atrial fibrillation Cardiac arrest Myocardial infarction
Frequency: 2 affected / 53 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Notes: Blood bilirubin increased
Frequency: 2 affected / 53 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia Leukocytosis
Frequency: 1 affected / 53 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post procedural hematuria
Frequency: 1 affected / 53 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite
Frequency: 1 affected / 53 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Mental status changes
Frequency: 1 affected / 53 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Stevens-Johnson syndrome
Frequency: 1 affected / 53 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Notes: Vena cava thrombosis
Frequency: 1 affected / 53 at risk

Adverse event: Respiratory, Thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary embolism Chronic obstructive pulmonary disease Pleural effusion
Frequency: 5 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 53 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 53 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 53 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 53 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 53 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 12 affected / 53 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 53 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 53 at risk