Study: NCT00634751

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Limb
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: INR (International Normalized Ratio of Prothrombin Time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Mucositis/stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 9 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 9 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 9 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Dermal change lymphedema, phlebolymphedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dermatology - peeling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 9 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 9 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 6 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 9 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 9 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

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

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 9 at risk

Adverse event: Liver dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 9 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 9 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 9 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 9 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 9 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 9 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 9 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 9 at risk

Adverse event: Stricture/stenosis (including anastomotic), GI - Biliary tree
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 9 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 9 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 7 at risk

Adverse event: Fistula, GI - Pancreas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Hemorrhage/bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 7 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 7 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 7 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Distension/bloating
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: INR (International Normalized Ratio of Prothrombin Time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Intra-operative injury
Serious: yes
Organ System: Surgical and medical procedures
Notes: Duodenum
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 24 at risk

Adverse event: Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 duodenum; 1 gallbladder
Frequency: 1 affected / 24 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Stricture/stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Duodenum
Frequency: 1 affected / 24 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 24 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 24 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 11 affected / 24 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 24 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 24 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 24 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Auditory/ear - hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 24 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 24 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 24 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 24 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 24 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 24 at risk

Adverse event: Distension/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 24 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 24 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 14 affected / 24 at risk

Adverse event: Hemorrhage/bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 24 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 24 at risk

Adverse event: Intra-operative injury - NERVES: CN V (trigeminal) sensory
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 24 at risk

Adverse event: Blood lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 24 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 24 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Magnesium, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 24 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 24 at risk

Adverse event: Musculoskeletal/Soft Tissue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 24 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 24 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 24 at risk

Adverse event: Obstruction, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ocular/visual - other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 24 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 24 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 24 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 24 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 24 at risk

Adverse event: PTT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 24 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 24 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sinus drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Stricture/stenosis (including anastomotic), GI - Biliary tree
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 24 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vision - blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 24 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 24 at risk

Adverse event: Watery eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 24 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 8 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 duodenum; 1 gallbladder
Frequency: 1 affected / 8 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 8 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 8 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 8 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 8 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 8 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Hemorrhage/bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 8 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Ileus, Ascites, Abdominal Pain, Anorexia, Oliguria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 8 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Jaundice
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 8 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Magnesium, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 8 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Obstruction, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 8 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 8 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 8 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 8 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vision - flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 8 at risk