Study: NCT02775162

Adverse event: Blood Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 136 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 136 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 136 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Infection Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Bile Leak
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 136 at risk

Adverse event: Biliary Stricture (Anastomotic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 136 at risk

Adverse event: Ischemic Cholangiopathy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Biliary Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 136 at risk

Adverse event: Hepatic artery thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 136 at risk

Adverse event: Hepatic artery stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hepatic Artery Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Transplant dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 136 at risk

Adverse event: Rejection
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 136 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 136 at risk

Adverse event: Hepatic Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 136 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 136 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 136 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 136 at risk

Adverse event: Cardiovascular Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 136 at risk

Adverse event: Dermatologic Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 136 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 136 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 136 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 136 at risk

Adverse event: Gastrointestinal Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 136 at risk

Adverse event: Renal Dysfunction/Acute Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 136 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Genitourinary Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 136 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Musculoskeletal Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 136 at risk

Adverse event: Cold/Flu
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 136 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 136 at risk

Adverse event: Respiratory Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 136 at risk

Adverse event: Bleeding - No Transfusion Required
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 136 at risk

Adverse event: Bleeding - Transfusion Required
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 136 at risk

Adverse event: Bleeding from Hepatic Artery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Bleeding from IVC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Bleeding Requiring Reoperation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 136 at risk

Adverse event: Bleeding Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Abdominal Collection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 136 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 136 at risk

Adverse event: Ascites
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 136 at risk

Adverse event: Extremities Edema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 136 at risk

Adverse event: Fluid Collection Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 136 at risk

Adverse event: Surgery - Planned/Elective
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 136 at risk

Adverse event: Surgery - Emergency
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 136 at risk

Adverse event: Other Systemic Disease/Event
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 136 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 136 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 136 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Malignancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Thrombocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hematology Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 136 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 136 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 136 at risk

Adverse event: Psychiatric Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 136 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 136 at risk

Adverse event: Neurology/Psychiatry Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 136 at risk

Adverse event: EAD - Serum Bilirubin
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 136 at risk

Adverse event: EAD - ALT or AST
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 136 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 64 affected / 136 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 136 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 136 at risk

Adverse event: Hematology Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 136 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 136 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 136 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 136 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 136 at risk

Adverse event: Gastrointestinal Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 136 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 136 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 136 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 136 at risk

Adverse event: Renal Dysfunction/Acute Kidney Injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 37 affected / 136 at risk

Adverse event: Genitourinary Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 136 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 136 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 136 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 136 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 136 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 136 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 136 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 136 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 136 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 136 at risk

Adverse event: Extremities Edema
Serious: no
Organ System: General disorders
Frequency: 29 affected / 136 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: General disorders
Frequency: 11 affected / 136 at risk

Adverse event: Transplant dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 136 at risk

Adverse event: Rejection
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 136 at risk

Adverse event: Blood Infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 136 at risk

Adverse event: Infection Other
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 136 at risk

Adverse event: Other Systemic Disease/Event
Serious: no
Organ System: General disorders
Frequency: 18 affected / 136 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 136 at risk

Adverse event: Musculoskeletal Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 136 at risk

Adverse event: Respiratory Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 136 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 136 at risk

Adverse event: Dermatologic Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 136 at risk

Adverse event: EAD - ALT or AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 136 at risk

Adverse event: Bleeding - Transfusion Required
Serious: no
Organ System: General disorders
Frequency: 3 affected / 136 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Blood Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 131 at risk

Adverse event: Biliary Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 131 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 131 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 131 at risk

Adverse event: Infection Other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 131 at risk

Adverse event: Bile Leak
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 131 at risk

Adverse event: Biliary Stricture (Anastomotic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 131 at risk

Adverse event: Ischemic Cholangiopathy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 131 at risk

Adverse event: Biliary Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 131 at risk

Adverse event: Hepatic artery thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 131 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 131 at risk

Adverse event: Transplant dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 131 at risk

Adverse event: Rejection
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 131 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 131 at risk

Adverse event: Hepatic Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 131 at risk

Adverse event: Allery - Drug
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 131 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 131 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 131 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 131 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 131 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 131 at risk

Adverse event: Cardiovascular Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 131 at risk

Adverse event: Hematoma/Bruising
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 131 at risk

Adverse event: Dermatologic Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 131 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 131 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 131 at risk

Adverse event: Gastrointestinal Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 131 at risk

Adverse event: Renal Dysfunction/Acute Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 131 at risk

Adverse event: Musculoskeletal Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 131 at risk

Adverse event: Cold/Flu
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 131 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 131 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 131 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 131 at risk

Adverse event: Respiratory Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 131 at risk

Adverse event: Bleeding - Transfusion Required
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 131 at risk

Adverse event: Bleeding from Hepatic Artery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 131 at risk

Adverse event: Bleeding from IVC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 131 at risk

Adverse event: Bleeding Requiring Reoperation
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 131 at risk

Adverse event: Bleeding Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 131 at risk

Adverse event: Abdominal Collection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 131 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 131 at risk

Adverse event: Ascites
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 131 at risk

Adverse event: Extremities Edema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 131 at risk

Adverse event: Fluid Collection Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 131 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 131 at risk

Adverse event: Surgery - Planned/Elective
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 131 at risk

Adverse event: Surgery - Emergency
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 131 at risk

Adverse event: Other Systemic Disease/Event
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 131 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 131 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 131 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Malignancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 131 at risk

Adverse event: Hematology Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 131 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 131 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 131 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 131 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 131 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 131 at risk

Adverse event: Psychiatric Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 131 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 131 at risk

Adverse event: EAD - ALT or AST
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 131 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 68 affected / 131 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 131 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 131 at risk

Adverse event: Hematology Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 131 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 131 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 131 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 131 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 131 at risk

Adverse event: Gastrointestinal Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 131 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 131 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 131 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 131 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 131 at risk

Adverse event: Renal Dysfunction/Acute Kidney Injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 41 affected / 131 at risk

Adverse event: Genitourinary Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 131 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 131 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 131 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 131 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 131 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 131 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 131 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 131 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 131 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 131 at risk

Adverse event: Extremities Edema
Serious: no
Organ System: General disorders
Frequency: 28 affected / 131 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: General disorders
Frequency: 10 affected / 131 at risk

Adverse event: Transplant dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 18 affected / 131 at risk

Adverse event: Rejection
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 131 at risk

Adverse event: Blood Infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 131 at risk

Adverse event: Infection Other
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 131 at risk

Adverse event: Other Systemic Disease/Event
Serious: no
Organ System: General disorders
Frequency: 29 affected / 131 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 131 at risk

Adverse event: Musculoskeletal Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 131 at risk

Adverse event: Respiratory Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 131 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 131 at risk

Adverse event: Dermatologic Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 131 at risk

Adverse event: EAD - ALT or AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 131 at risk

Adverse event: Bleeding - Transfusion Required
Serious: no
Organ System: General disorders
Frequency: 11 affected / 131 at risk