Study: NCT01009983

Adverse event: Low WBC
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 14 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 14 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 14 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 14 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 14 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 14 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 14 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Breast
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 14 at risk

Adverse event: Pain: Extremity-limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urinary with low grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Death not associated with CTCAE term: Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 14 at risk

Adverse event: Hemorrhage, GI: Upper GI
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 7 affected / 14 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 14 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 12 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 14 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 14 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 14 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 14 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 14 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Low ANC
Serious: no
Organ System: Investigations
Frequency: 5 affected / 14 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 14 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 14 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 14 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 14 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 14 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 14 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 14 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Bicarbonate serum-low
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 14 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 14 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 14 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 14 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 14 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Speech impairment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 14 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 14 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Ataxia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Pain: Bone
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Breast
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Chest/thorax
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 14 at risk

Adverse event: Hemorrhage respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rash: erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 14 at risk

Adverse event: Extremity-lower (gait/walking)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Voice changes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 14 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 14 at risk

Adverse event: Memory impairment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 4 affected / 14 at risk

Adverse event: Nail disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 14 at risk

Adverse event: International Normalized Ratio of prothrombin time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Hemorrhage, GI: Rectum
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Kidney
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 14 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 14 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Pain: Urethra
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hemorrhage Bladder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urinary with low grade neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Lymphatics - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 14 at risk

Adverse event: Infection with unknown ANC Lung (pneumonia)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Laryngeal nerve dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Syndromes - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk