Study: NCT01273766

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Heartburn/dyspepsia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: "Distension bloating, abdominal"
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Lipase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Nose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

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

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

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

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

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

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Intra-operative Injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Musculoskeletal Soft Tissue - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ataxia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Obstruction Bladder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bladder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Bronchospasm wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Urine color change
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: gamma-Glutamyl transpeptidase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Memory impairment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain Oral cavity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hemorrhage GU: Urinary
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 4 at risk

Adverse event: Infection Lip perioral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Blood Infection with high grade neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk