Study: NCT01954745

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 19 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: PPE
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Elevated AST
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Elevated AST
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Elevated Serum ALKP
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Lipasemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 19 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 19 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 19 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dyspepsia/Heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 19 at risk

Adverse event: Palmar Plantar Erythrodysesthesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 19 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 19 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Flatulence
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Cough
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Psychiatric d/o
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Elevated ALKP
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 19 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 19 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 19 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 19 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk