Study: NCT01553539

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Abdomen
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Alkalosis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Obstruction, GI: Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 20 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain: Extremity-limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain: Pleura
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Pain: Stomach
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Supraventricular and nodal arrhythmia: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Obstruction, GU: Ureter
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain: Urethra
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urinary with low grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Oral cavity-gums
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Prolapse of stoma, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Infection Biliary tree
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Infection with unknown ANC Lung (pneumonia)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Intra-operative injury: Spinal cord
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blood Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Bicarbonate serum-low
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pain: Dental/teeth/peridontal
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain: Chest/thorax
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hemorrhage pulmonary/upper respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: General disorders
Frequency: 4 affected / 20 at risk

Adverse event: Bronchospasm wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 20 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 20 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 9 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 20 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 20 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 20 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 14 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 14 affected / 20 at risk