Study: NCT01054144

Adverse event: General Cardiac Disorders - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Coagulation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: General disorders - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Fever in the absence of neutropenia where neutropenia is defined as ANC \<1.0 x 10e9/L
Frequency: 1 affected / 27 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death not associated with CTCAE term - Sudden death
Frequency: 1 affected / 27 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Gastrointestinal disorders, other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hemorrhage, Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Colitis, Infectious (e.g. Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Infection -Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Infection - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Infection - Bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Investigations -Other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Limb pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain -Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 27 at risk

Adverse event: Vascular -Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Non-myocardial vascular arterial ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 27 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 27 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 27 at risk

Adverse event: Distension/bloating, Abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Mucositis/stomatitis - oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Obstruction, GI - Colon
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 27 at risk

Adverse event: Fever (in absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 27 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 27 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 27 at risk

Adverse event: Constitutional symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Neutrophils/granulocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 27 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 27 at risk

Adverse event: Low platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 27 at risk

Adverse event: Hemoglobin, low
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 27 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Skin and subcutaneous tissue disorders -Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 27 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 27 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 27 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 27 at risk

Adverse event: Rash, erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 27 at risk

Adverse event: Brusing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 27 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rash, acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermatitis associated with chemoradiation
Frequency: 1 affected / 27 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 27 at risk

Adverse event: Pain - extremity/limb
Serious: no
Organ System: General disorders
Frequency: 16 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 27 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 27 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 27 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Chest/thorax pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Pain-throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Pain - stomach
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Pain - muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Pain - NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain - lymph node
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain - oral, gum
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Breast pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - dental
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - external ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Biliary colic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Oral cavity pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - testicle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Neuropathy, sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 27 at risk

Adverse event: Nervous system disorders -Other
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 27 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 27 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 27 at risk

Adverse event: Neuropathy, motor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 27 at risk

Adverse event: Agitation/Iritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 27 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Neuropathy, cranial
Serious: no
Organ System: Nervous system disorders
Notes: CN VIII hearing and balance
Frequency: 1 affected / 27 at risk

Adverse event: Personality/Behavior changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 16 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 27 at risk

Adverse event: Respirator, thoracic and mediastrinal disorders -Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Loss or alteration of voice
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Paranasal/sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Obstruction of airway
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Edema - limb
Serious: no
Organ System: General disorders
Frequency: 21 affected / 27 at risk

Adverse event: Edema -head and neck
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Edema - trunk
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal and connective tissue disorders - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 27 at risk

Adverse event: Muscle weakess, generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 27 at risk

Adverse event: Muscle weakness, extraocular
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Muscle weakness, lower extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Gait changes
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Muscle weakness, trunk
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 27 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 27 at risk

Adverse event: Infection -Other
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Bronchus infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Upper airway infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Conjunctiva infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Peripheral nerve infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Gingivitus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Colon infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 27 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: ALT, SGPT high
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Frequency: 11 affected / 27 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk