Study: NCT00470184

Adverse event: Pericardial effusion - Grade 3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pericarditis - Grade 2
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Intestinal obstruction - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oesophageal fistula - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oesophagitis - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Small intestinal stenosis - Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Death - Grade 5
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Fatigue - Grade 3
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Infection - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Pneumonia - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Wound infection - Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Anastomotic leak - Grade 3
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Platelet count decreased - Grade 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Flank pain - Grade 2
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Metastasis - Grade 4
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 36 at risk

Adverse event: Aspiration - Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pleural effusion - Grade 2
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pulmonary embolism - Grade 4
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Anaemia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Anaemia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Anaemia - Grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Leukopenia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 36 at risk

Adverse event: Leukopenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Leukopenia - Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Lymphopenia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 36 at risk

Adverse event: Lymphopenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 36 at risk

Adverse event: Lymphopenia - Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 36 at risk

Adverse event: Lymphopenia - Grade 4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 36 at risk

Adverse event: Neutropenia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Neutropenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Neutropenia - Grade 3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Thrombocytopenia - Grade 1
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 36 at risk

Adverse event: Arrhythmia - Grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Atrial fibrillation - Grade 2
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 36 at risk

Adverse event: Palpitations - Grade 2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sinus tachycardia - Grade 2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Tachycardia - Grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eye discharge - Grade 1
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Photopsia - Grade 1
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vision blurred - Grade 1
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Visual disturbance - Grade 1
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal distension - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Abdominal pain - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 36 at risk

Adverse event: Abdominal pain - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Abdominal pain upper - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Abdominal pain upper - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ascites - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Constipation - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 36 at risk

Adverse event: Constipation - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Diarrhoea - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 36 at risk

Adverse event: Diarrhoea - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 36 at risk

Adverse event: Dry mouth - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dyspepsia - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Dyspepsia - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dysphagia - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 36 at risk

Adverse event: Dysphagia - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Dysphagia - Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Eructation - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Flatulence - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Flatulence - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gastritis - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gastrointestinal haemorrhage - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Impaired gastric emptying - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Mouth ulceration - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Nausea - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 36 at risk

Adverse event: Nausea - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 36 at risk

Adverse event: Odynophagia - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Oesophageal pain - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Oesophageal stenosis - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oesophageal stenosis - Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Oesophagitis - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Oesophagitis - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 36 at risk

Adverse event: Pancreatic insufficiency - Grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rectal haemorrhage - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Reflux oesophagitis - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Stomatitis - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vomiting - Grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 36 at risk

Adverse event: Vomiting - Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 36 at risk

Adverse event: Asthenia - Grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Asthenia - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Chest discomfort - Grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Chest pain - Grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Chest pain - Grade 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Chills - Grade 1
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Early satiety - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Fatigue - Grade 1
Serious: no
Organ System: General disorders
Frequency: 27 affected / 36 at risk

Adverse event: Fatigue - Grade 2
Serious: no
Organ System: General disorders
Frequency: 12 affected / 36 at risk

Adverse event: Fibrosis - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Infusion site reaction - Grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Injection site pain - Grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Injection site phlebitis - Grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Injection site phlebitis - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Injection site reaction - Grade 1
Serious: no
Organ System: General disorders
Frequency: 7 affected / 36 at risk

Adverse event: Injection site reaction - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Malaise - Grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Mucosal inflammation - Grade 1
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Oedema peripheral - Grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pain - Grade 1
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Pyrexia - Grade 1
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Pyrexia - Grade 2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Systemic inflammatory response syndrome - Grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperbilirubinaemia - Grade 1
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperbilirubinaemia - Grade 2
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hyperbilirubinaemia - Grade 3
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 36 at risk

Adverse event: Hypersensitivity - Grade 3
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Bronchitis - Grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Candidiasis - Grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Eye infection - Grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Fungal infection - Grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Gastroenteritis - Grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Infection - Grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Infection - Grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: Infection - Grade 3
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 36 at risk

Adverse event: Opportunistic infection - Grade 3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Pneumonia - Grade 3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Upper respiratory tract infection - Grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Anastomotic leak - Grade 1
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Incision site complication - Grade 3
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Seroma - Grade 1
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Alanine aminotransferase - Grade 1
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Alanine aminotransferase - Grade 2
Serious: no
Organ System: Investigations
Frequency: 3 affected / 36 at risk

Adverse event: Alanine aminotransferase decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Alanine aminotransferase increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 13 affected / 36 at risk

Adverse event: Alanine aminotransferase increased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 9 affected / 36 at risk

Adverse event: Alanine aminotransferase increased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Aspartate aminotransferase - Grade 1
Serious: no
Organ System: Investigations
Frequency: 7 affected / 36 at risk

Adverse event: Aspartate aminotransferase - Grade 2
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Aspartate aminotransferase - Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Aspartate aminotransferase decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Aspartate aminotransferase increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 28 affected / 36 at risk

Adverse event: Aspartate aminotransferase increased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 13 affected / 36 at risk

Adverse event: Aspartate aminotransferase increased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 6 affected / 36 at risk

Adverse event: Blood albumin decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Blood albumin decreased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 7 affected / 36 at risk

Adverse event: Blood albumin decreased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Blood alkaline phosphatase - Grade 1
Serious: no
Organ System: Investigations
Frequency: 14 affected / 36 at risk

Adverse event: Blood alkaline phosphatase - Grade 2
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Blood alkaline phosphatase increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 9 affected / 36 at risk

Adverse event: Blood alkaline phosphatase increased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Blood alkaline phosphatase increased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood bilirubin - Grade 1
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Blood bilirubin - Grade 2
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood calcium decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Blood calcium decreased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 5 affected / 36 at risk

Adverse event: Blood calcium increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood creatine increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood creatine phosphokinase - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood creatinine - Grade 1
Serious: no
Organ System: Investigations
Frequency: 5 affected / 36 at risk

Adverse event: Blood creatinine - Grade 2
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood glucose decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Blood glucose increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 6 affected / 36 at risk

Adverse event: Blood glucose increased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Blood glucose increased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Blood potassium decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Blood potassium increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Blood potassium increased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Blood sodium decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 7 affected / 36 at risk

Adverse event: Blood sodium increased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 3 affected / 36 at risk

Adverse event: Haemoglobin - Grade 1
Serious: no
Organ System: Investigations
Frequency: 26 affected / 36 at risk

Adverse event: Haemoglobin - Grade 2
Serious: no
Organ System: Investigations
Frequency: 12 affected / 36 at risk

Adverse event: Haemoglobin - Grade 3
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Haemoglobin decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 7 affected / 36 at risk

Adverse event: Haemoglobin decreased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 4 affected / 36 at risk

Adverse event: Lymphocyte count decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Lymphocyte count decreased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Platelet count - Grade 1
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Platelet count decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 26 affected / 36 at risk

Adverse event: Platelet count decreased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 5 affected / 36 at risk

Adverse event: Transaminases increased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Troponin I - Grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Weight decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 7 affected / 36 at risk

Adverse event: Weight decreased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 12 affected / 36 at risk

Adverse event: Weight decreased - Grade 3
Serious: no
Organ System: Investigations
Frequency: 3 affected / 36 at risk

Adverse event: White blood cell count decreased - Grade 1
Serious: no
Organ System: Investigations
Frequency: 7 affected / 36 at risk

Adverse event: White blood cell count decreased - Grade 2
Serious: no
Organ System: Investigations
Frequency: 3 affected / 36 at risk

Adverse event: Anorexia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 36 at risk

Adverse event: Anorexia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 36 at risk

Adverse event: Anorexia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dehydration - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 36 at risk

Adverse event: Gout - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypercalcaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hyperglycaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 36 at risk

Adverse event: Hyperglycaemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 36 at risk

Adverse event: Hyperglycaemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hyperkalaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 36 at risk

Adverse event: Hypermagnesaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 36 at risk

Adverse event: Hypermagnesaemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypermagnesaemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypernatraemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 36 at risk

Adverse event: Hypernatraemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypernatraemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypoalbuminaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 36 at risk

Adverse event: Hypoalbuminaemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 36 at risk

Adverse event: Hypoalbuminaemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hypocalcaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 36 at risk

Adverse event: Hypocalcaemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 36 at risk

Adverse event: Hypocalcaemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypoglycaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 36 at risk

Adverse event: Hypoglycaemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypokalaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 36 at risk

Adverse event: Hypokalaemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypokalaemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: Hypomagnesaemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 36 at risk

Adverse event: Hypomagnesaemia - Grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 36 at risk

Adverse event: Hyponatraemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 36 at risk

Adverse event: Hyponatraemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypophosphataemia - Grade 1
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hypophosphataemia - Grade 3
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Back pain - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Back pain - Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Gouty arthritis - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Gouty arthritis - Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Muscle spasms - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Muscular weakness - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Muscular weakness - Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Musculoskeletal chest pain - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Myalgia - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pain in extremity - Grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pain in extremity - Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dizziness - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 36 at risk

Adverse event: Dysaesthesia - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dysgeusia - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 36 at risk

Adverse event: Dysgeusia - Grade 2
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Headache - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Hyperaesthesia - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Hypoaesthesia - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Neuroleptic malignant syndrome - Grade 3
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Neuropathy - Grade 2
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Paraesthesia - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 36 at risk

Adverse event: Paraesthesia - Grade 2
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Paraesthesia - Grade 3
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Peripheral sensory neuropathy - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 36 at risk

Adverse event: Peripheral sensory neuropathy - Grade 2
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Peroneal nerve palsy - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Restless legs syndrome - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Tremor - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vocal cord paralysis - Grade 1
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Anxiety - Grade 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Anxiety disorder - Grade 2
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Confusional state - Grade 2
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Depression - Grade 2
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk

Adverse event: Drug dependence - Grade 2
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Insomnia - Grade 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 36 at risk

Adverse event: Insomnia - Grade 2
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Chromaturia - Grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dysuria - Grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Renal failure acute - Grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Aspiration - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Choking sensation - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Chylothorax - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cough - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 36 at risk

Adverse event: Cough - Grade 3
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dysphonia - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 36 at risk

Adverse event: Dysphonia - Grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dyspnoea - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 36 at risk

Adverse event: Dyspnoea - Grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dyspnoea exertional - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Hiccups - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pharyngolaryngeal pain - Grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pleural effusion - Grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Pleural effusion - Grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pneumonitis - Grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Dermatitis - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Drug eruption - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperhidrosis - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 36 at risk

Adverse event: Hyperhidrosis - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Photosensitivity reaction - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pruritus - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 36 at risk

Adverse event: Pruritus - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 36 at risk

Adverse event: Rash - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 36 at risk

Adverse event: Rash - Grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash generalised - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash macular - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash macular - Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Skin hyperpigmentation - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Skin lesion - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Skin odour abnormal - Grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Deep vein thrombosis - Grade 3
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 36 at risk

Adverse event: Flushing - Grade 1
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypertension - Grade 1
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypertension - Grade 3
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypotension - Grade 2
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 36 at risk

Adverse event: Lymphorrhoea - Grade 2
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Orthostatic hypotension - Grade 1
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Orthostatic hypotension - Grade 2
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Phlebitis - Grade 2
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 36 at risk