Study: NCT00126503

Adverse event: Edema-limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory-nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pain-chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Musculoskeletal/soft tissue-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Neuropathy - sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pain-abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Pain-joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Somnomolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 48 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: Vascular-other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Infection with unknown ANC-pancreas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Infection with unknown ANC-lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Death not associated with CTCAE term-Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Supraventricular and nodal arrhythmia-atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Infection-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Infection with Grade 1 or 2 neutrophils (ANC < 1.0 x 10e9/L)-skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 48 at risk

Adverse event: Cardiac General-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pain-back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Supraventricular and nodal arrhythmia-atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: stricture/stenosis (including anastomotic), GI-jejunum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Oral mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: palmar-plantar paresthesia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 48 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 48 at risk

Adverse event: ALT/SGPT (serum glutamine pyruvic transminase)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 48 at risk

Adverse event: AST, SGOT (serum glutamine oxaloacetic transminase)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 48 at risk

Adverse event: Bruising (in absence of Grade 3/4 thromboctyopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 48 at risk

Adverse event: Constitutional symptoms Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 48 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 48 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 48 at risk

Adverse event: Dermatology/Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 48 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 48 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 48 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 48 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 48 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 48 at risk

Adverse event: Edema head and neck
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 7 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 38 affected / 48 at risk

Adverse event: Fever (in the absence of neutropenia, with neutropenia defined as ANC < 1.0 x 10e9/L
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 48 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 48 at risk

Adverse event: Gastrointestinal-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: hair loss-scalp or body
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: Heartburn, dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 48 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 48 at risk

Adverse event: Hemorrhage, GI oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hemorrhage, GI rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory-nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 48 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 48 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 48 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 48 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 48 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 48 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 48 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 48 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 48 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils-cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 48 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 48 at risk

Adverse event: Mood alteration-anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 48 at risk

Adverse event: Mood alteration-depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 48 at risk

Adverse event: Mucositis/stomatitis-anus/rectum (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Mucositis/stomatitis-oral cavity (clinical exam)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 48 at risk

Adverse event: Muscle weakness, generalized or specific area-upper extremity/whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Musculoskeletal/soft tissue-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 48 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 48 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 48 at risk

Adverse event: Pain-abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 17 affected / 48 at risk

Adverse event: Pain-anus/rectum
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Pain-back
Serious: no
Organ System: General disorders
Frequency: 17 affected / 48 at risk

Adverse event: Pain-bone
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Pain-chest/thorax
Serious: no
Organ System: General disorders
Frequency: 6 affected / 48 at risk

Adverse event: Pain-dental/periodontal
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Pain-Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 48 at risk

Adverse event: Pain-joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 48 at risk

Adverse event: Pain-oral cavity/gums
Serious: no
Organ System: General disorders
Frequency: 8 affected / 48 at risk

Adverse event: Pain-Other/NOS
Serious: no
Organ System: General disorders
Frequency: 10 affected / 48 at risk

Adverse event: Pain-sinus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Pain-stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 48 at risk

Adverse event: Pain-throat, pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 48 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 4 affected / 48 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 48 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 48 at risk

Adverse event: Pulmonary\upper respiratory-Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 48 at risk

Adverse event: Rash acne/actiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 48 at risk

Adverse event: palmar/plantar paresthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 48 at risk

Adverse event: Rigor, chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 48 at risk

Adverse event: Sweating/diphoresis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 48 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 48 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 48 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 48 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 48 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 48 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Pain-breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 48 at risk

Adverse event: Pain-extremity. limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 48 at risk

Adverse event: Pain-muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 48 at risk

Adverse event: Pain-neck
Serious: no
Organ System: General disorders
Frequency: 6 affected / 48 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 48 at risk

Adverse event: Pain-scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 48 at risk

Adverse event: Tumour pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 48 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 48 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 48 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 48 at risk

Adverse event: Pain-chest wall
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain-abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with Grade 1 or 2 neutrophils (ANC < 1.0 x 10e9/L)-skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Obstruction, GI-gallbladder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils-bone (osteomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Perforation, GI-colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: allergic reaction/hypersensivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 21 at risk

Adverse event: ALT/SGPT (serum glutamine pyruvic transminase)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 21 at risk

Adverse event: AST, SGOT (serum glutamine oxaloacetic transminase)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 21 at risk

Adverse event: Bronchospasm-wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Bruising (in absence of Grade 3/4 thromboctyopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 21 at risk

Adverse event: Constitutional symptoms Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 21 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dental-teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Dermatology/Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 21 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 21 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Edema head and neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 6 affected / 21 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Extemity-lower (gait/walking)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 21 at risk

Adverse event: Fever (in the absence of neutropenia, with neutropenia defined as ANC < 1.0 x 10e9/L
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: fistula-GI anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastrointestinal-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: hair loss-scalp or body
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 21 at risk

Adverse event: Heartburn, dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 21 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Hemorrhage, GI-lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hemorrhage, GI oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hemorrhage, GI rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hemorrhage, GU urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hemorrhage, GU vaginal
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory-nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 21 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 21 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 21 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 21 at risk

Adverse event: Infection-Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 21 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Metabolic/laboratory-Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Mood alteration-agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 21 at risk

Adverse event: Mood alteration-anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Mood alteration-depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Mucositis/stomatitis-anus/rectum (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Mucositis/stomatitis-oral cavity (clinical exam)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 21 at risk

Adverse event: Muscle weakness, generalized or specific area-upper extremity/whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 21 at risk

Adverse event: Neurology-Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 21 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 21 at risk

Adverse event: Ocular/visual-Other
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 21 at risk

Adverse event: Otitis, middle ear (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain-abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 21 at risk

Adverse event: Pain-back
Serious: no
Organ System: General disorders
Frequency: 8 affected / 21 at risk

Adverse event: Pain-bone
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain-chest/thorax
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Pain-Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 21 at risk

Adverse event: Pain-joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 21 at risk

Adverse event: Pain-oral cavity/gums
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain-Other/NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Pain-pelvis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain-sinus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Pain-throat, pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 21 at risk

Adverse event: Pulmonary\upper respiratory-Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 21 at risk

Adverse event: Rash acne/actiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: palmar/plantar paresthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 21 at risk

Adverse event: Renal/Genitourinary-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Rigor, chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 21 at risk

Adverse event: Sweating/diphoresis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Syncope/fainting
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 21 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 21 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 21 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Vascular-other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 21 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 21 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 21 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 21 at risk

Adverse event: Chelitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Endocrine other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 21 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessnes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with unknown ANC-cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Infection with unknown ANC-soft tissue
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Pain-extremity. limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 21 at risk

Adverse event: Pain-buttock
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain-muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Pain-neck
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Pain-skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 21 at risk

Adverse event: Pain-scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils-external ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils-Eye NOS
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils-lung (pneumonia)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with unknown ANC-stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with unknown ANC-wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Leak (including anastomatic)-GI-rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Occular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Partial prothrombin time (PTT)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Supraventricular and nodal arrhythmia-atrial tachycardia/paroxysmal atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Triglyceride, serum-high
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils-sinus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils-upper airway NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)-Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 21 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: pneumonitis/pumonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vessel injury-vein-extremity-limb
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk