Study: NCT00855218

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 153 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 153 at risk

Adverse event: PLATELETS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 153 at risk

Adverse event: CARDIAC ISCHEMIA/INFARCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 153 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: SUPRAVENTRICULAR ARRHYTHMIA, ATRIAL FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 153 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 153 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: GI - OTHER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 153 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: LEAK, GI, BILIARY TREE
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: PERFORATION, GI, GALLBLADDER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: PERFORATION, GI, STOMACH
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS - OTHER
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 153 at risk

Adverse event: DEATH NOT ASSOCIATED WITH CTCAE TERM, DISEASE PROGRESSION NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 153 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 153 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 153 at risk

Adverse event: PAIN, BACK
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: PAIN, BONE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: PAIN, JOINT
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: PAIN, STOMACH
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: SYNDROMES - OTHER
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 153 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 153 at risk

Adverse event: HEPATOBILIARY - OTHER
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 153 at risk

Adverse event: LIVER DYSFUNCTION
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 153 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), BLADDER (URINARY)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), BLOOD
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), LIVER
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 153 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), PERITONEAL CAVITY
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 153 at risk

Adverse event: INFECTION WITH NORMAL ANC, APPENDIX
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION WITH NORMAL ANC, BILIARY TREE
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION WITH NORMAL ANC, BLOOD
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 153 at risk

Adverse event: INFECTION WITH NORMAL ANC, LIVER
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION WITH NORMAL ANC, PERITONEAL CAVITY
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION WITH NORMAL ANC, SKIN (CELLULITIS)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION WITH UNKNOWN ANC, BONE (OSTEOMYELITIS)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: INFECTION WITH UNKNOWN ANC, LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 153 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 153 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 153 at risk

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 153 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 153 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 153 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 153 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 153 at risk

Adverse event: SECONDARY MALIGNANCY (POSSIBLY RELATED TO CANCER TREATMENT)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 153 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 153 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 153 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 153 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 153 at risk

Adverse event: PULMONARY - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: RASH/DESQUAMATION
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 153 at risk

Adverse event: ARTERY INJURY, EXTREMITY - LOWER
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: ARTERY INJURY, OTHER NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: HEMORRHAGE PULMONARY, BRONCHOPULMONARY NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: HEMORRHAGE WITH SURGERY
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, ABDOMEN NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, ESOPHAGUS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, LIVER
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, LOWER GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, RECTUM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, STOMACH
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, UPPER GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, VARICES (ESOPHAGEAL)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 153 at risk

Adverse event: HEMORRHAGE, GI, VARICES (RECTAL)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: VASCULAR - OTHER
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 153 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 153 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 153 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 153 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 153 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 153 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 153 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 153 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 153 at risk

Adverse event: DISTENSION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 153 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 153 at risk

Adverse event: GI - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 153 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 153 at risk

Adverse event: MUCOSITIS (FUNCTIONAL/SYMPTOMATIC), ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 153 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 153 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 153 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 65 affected / 153 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 153 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: no
Organ System: General disorders
Frequency: 6 affected / 153 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 153 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: no
Organ System: General disorders
Frequency: 93 affected / 153 at risk

Adverse event: PAIN, BACK
Serious: no
Organ System: General disorders
Frequency: 12 affected / 153 at risk

Adverse event: PAIN, CHEST/THORAX NOS
Serious: no
Organ System: General disorders
Frequency: 9 affected / 153 at risk

Adverse event: PAIN, EXTREMITY-LIMB
Serious: no
Organ System: General disorders
Frequency: 6 affected / 153 at risk

Adverse event: PAIN, HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 13 affected / 153 at risk

Adverse event: PAIN, JOINT
Serious: no
Organ System: General disorders
Frequency: 13 affected / 153 at risk

Adverse event: PAIN, LIVER
Serious: no
Organ System: General disorders
Frequency: 6 affected / 153 at risk

Adverse event: PAIN, MUSCLE
Serious: no
Organ System: General disorders
Frequency: 18 affected / 153 at risk

Adverse event: PAIN, STOMACH
Serious: no
Organ System: General disorders
Frequency: 7 affected / 153 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 11 affected / 153 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 31 affected / 153 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 153 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 153 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 153 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 153 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 153 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 153 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 153 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 153 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 153 at risk

Adverse event: METABOLIC/LAB - OTHER
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 153 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 153 at risk

Adverse event: MOOD ALTERATION, ANXIETY
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 153 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 153 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 153 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 153 at risk

Adverse event: VOICE CHANGES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 153 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 153 at risk

Adverse event: DERMATOLOGY - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 153 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 153 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 71 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 153 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 153 at risk

Adverse event: HEMORRHAGE PULMONARY, NOSE
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 153 at risk

Adverse event: BLOOD - OTHER
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: EDEMA: LIMB
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: CARDIAC GENERAL - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: CARDIAC ISCHEMIA/INFARCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: PERFORATION, GI, DUODENUM
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: DEATH NOT ASSOCIATED WITH CTCAE TERM, DISEASE PROGRESSION NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: DEATH NOT ASSOCIATED WITH CTCAE TERM, MULTI-ORGAN FAILURE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: DEATH NOT ASSOCIATED WITH CTCAE TERM, SUDDEN DEATH
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 151 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 151 at risk

Adverse event: PAIN, CHEST WALL
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: PAIN, GALLBLADDER
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: PAIN, JOINT
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: PAIN, PLEURA
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: SYNDROMES - OTHER
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 151 at risk

Adverse event: HEPATOBILIARY - OTHER
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 151 at risk

Adverse event: LIVER DYSFUNCTION
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 151 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 151 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), BLOOD
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 151 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), BRONCHUS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), COLON
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), LIVER
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), PERITONEAL CAVITY
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), SKIN (CELLULITIS)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 151 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY), UPPER AIRWAY NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION WITH NORMAL ANC, BILIARY TREE
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION WITH NORMAL ANC, BLADDER (URINARY)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION WITH NORMAL ANC, PERITONEAL CAVITY
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION WITH NORMAL ANC, URINARY TRACT NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION WITH UNKNOWN ANC, LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: INFECTION WITH UNKNOWN ANC, PANCREAS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 151 at risk

Adverse event: METABOLIC/LAB - OTHER
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: JOINT-FUNCTION
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: MUSCLE WEAKNESS, LEFT-SIDED
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: SECONDARY MALIGNANCY (POSSIBLY RELATED TO CANCER TREATMENT)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: OBSTRUCTION, GU, PROSTATE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: RENAL - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 151 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: ARTERY INJURY, EXTREMITY - LOWER
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: HEMORRHAGE WITH SURGERY
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: HEMORRHAGE, GI, ABDOMEN NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: HEMORRHAGE, GI, PERITONEAL CAVITY
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: HEMORRHAGE, GI, STOMACH
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: HEMORRHAGE, GI, UPPER GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: HEMORRHAGE, GI, VARICES (ESOPHAGEAL)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 151 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 151 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 151 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 151 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 151 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 151 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 151 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 151 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 151 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 151 at risk

Adverse event: DISTENSION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 151 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 151 at risk

Adverse event: GI - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 151 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 151 at risk

Adverse event: MUCOSITIS (FUNCTIONAL/SYMPTOMATIC), ORAL CAVITY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 151 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 50 affected / 151 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 49 affected / 151 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: no
Organ System: General disorders
Frequency: 12 affected / 151 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 151 at risk

Adverse event: PAIN, ABDOMEN NOS
Serious: no
Organ System: General disorders
Frequency: 91 affected / 151 at risk

Adverse event: PAIN, BACK
Serious: no
Organ System: General disorders
Frequency: 14 affected / 151 at risk

Adverse event: PAIN, CHEST/THORAX NOS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 151 at risk

Adverse event: PAIN, EXTREMITY-LIMB
Serious: no
Organ System: General disorders
Frequency: 8 affected / 151 at risk

Adverse event: PAIN, HEAD/HEADACHE
Serious: no
Organ System: General disorders
Frequency: 6 affected / 151 at risk

Adverse event: PAIN, JOINT
Serious: no
Organ System: General disorders
Frequency: 15 affected / 151 at risk

Adverse event: PAIN, LIVER
Serious: no
Organ System: General disorders
Frequency: 11 affected / 151 at risk

Adverse event: PAIN, MUSCLE
Serious: no
Organ System: General disorders
Frequency: 11 affected / 151 at risk

Adverse event: PAIN, STOMACH
Serious: no
Organ System: General disorders
Frequency: 11 affected / 151 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 151 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 16 affected / 151 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 151 at risk

Adverse event: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 151 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 151 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 151 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 151 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 151 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 151 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 151 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 151 at risk

Adverse event: METABOLIC/LAB - OTHER
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 151 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 151 at risk

Adverse event: MOOD ALTERATION, ANXIETY
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 151 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 151 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 151 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 151 at risk

Adverse event: VOICE CHANGES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 151 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 151 at risk

Adverse event: DERMATOLOGY - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 151 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 151 at risk

Adverse event: HAND-FOOT SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 151 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 151 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 151 at risk

Adverse event: HEMORRHAGE PULMONARY, NOSE
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 151 at risk