Study: NCT01854827

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hepatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 29 at risk

Adverse event: Immunological
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 29 at risk

Adverse event: Infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 29 at risk

Adverse event: Metabolic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Neoplastic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 29 at risk

Adverse event: Nutritional
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 29 at risk

Adverse event: Surgical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 29 at risk

Adverse event: Post Operative Liver Transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 29 at risk

Adverse event: Acholic Stools
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 29 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 29 at risk

Adverse event: Ascites
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 29 at risk

Adverse event: Cold Systems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 29 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 28 affected / 29 at risk

Adverse event: Decreased Feeding
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 29 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Elevated Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 29 at risk

Adverse event: Elevated INR
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 29 at risk

Adverse event: Elevation in AST and/or ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Elevation in Systolic BP > 112
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 29 at risk

Adverse event: Feeding intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 29 at risk

Adverse event: Fussiness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 29 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 29 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Immunological
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 29 at risk

Adverse event: Inadequate wait gain
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Increased PT/INR
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Increased Sleepiness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 29 at risk

Adverse event: Infectious
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 29 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 29 at risk

Adverse event: Jaundice
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 29 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Neoplastic
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 29 at risk

Adverse event: Nutritional
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 29 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Weight gain poor
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 29 at risk

Adverse event: Post Operative Liver Transplant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 12 affected / 29 at risk

Adverse event: Pruitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 29 at risk

Adverse event: RSV
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 29 at risk

Adverse event: Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Surgical
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 29 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 29 at risk