Study: NCT00482677

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 271 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain Cardiac/heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Supraventricular arrhythmia Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Ventricular arrhythmia Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 271 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 271 at risk

Adverse event: Neuropathy: cranial CN II
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 271 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 271 at risk

Adverse event: Hemorrhage, GI Lower GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pain Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Perforation, GI Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Perforation, GI Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 271 at risk

Adverse event: Constitutional Symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Death Death NOS
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 271 at risk

Adverse event: Death Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 271 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 271 at risk

Adverse event: Gait/walking
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Syndromes - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Infection (documented clinically) Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection (documented clinically) Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 271 at risk

Adverse event: Infection (documented clinically) Muscle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection (documented clinically) Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 271 at risk

Adverse event: Infection with normal ANC Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 271 at risk

Adverse event: Infection with normal ANC Brain
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 271 at risk

Adverse event: Infection with normal ANC Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with unknown ANC Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with unknown ANC Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with unknown ANC Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with unknown ANC Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 271 at risk

Adverse event: Thrombosis/embolism (vascular access)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 271 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Gamma-glutamyltransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 271 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 271 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 271 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 271 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 271 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 271 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 271 at risk

Adverse event: Joint-function
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Muscle weakness Extremity-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 271 at risk

Adverse event: Muscle weakness Extremity-upper
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 271 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 271 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 271 at risk

Adverse event: Muscle weakness Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 271 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 271 at risk

Adverse event: Pain Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Arachnoiditis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 271 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 271 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 271 at risk

Adverse event: CSF leak
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 271 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 271 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 29 affected / 271 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Neuropathy: cranial CN III
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Neuropathy: cranial CN VII
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 271 at risk

Adverse event: Pyramidal tract dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 271 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 271 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 271 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 17 affected / 271 at risk

Adverse event: Mood alteration Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 271 at risk

Adverse event: Mood alteration Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 271 at risk

Adverse event: Mood alteration Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 271 at risk

Adverse event: Hemorrhage, GU Kidney
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Hemorrhage pulmonary Nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 271 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 271 at risk

Adverse event: Hearing (without monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 15 affected / 271 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 271 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 271 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 271 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 271 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 271 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 271 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 50 affected / 271 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 158 affected / 271 at risk

Adverse event: Gait/walking
Serious: no
Organ System: General disorders
Frequency: 22 affected / 271 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 271 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 271 at risk

Adverse event: Muscle weakness Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 271 at risk

Adverse event: Muscle weakness Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 271 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 271 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 271 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 271 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 271 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 66 affected / 271 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 271 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 77 affected / 271 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 271 at risk

Adverse event: Pain Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 64 affected / 271 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 271 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 271 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 271 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 271 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 66 affected / 271 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 271 at risk

Adverse event: Mood alteration Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 271 at risk

Adverse event: Mood alteration Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 271 at risk

Adverse event: Mood alteration Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 271 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 271 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 271 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 271 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 271 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 69 affected / 271 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 271 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 271 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 34 affected / 271 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Supraventricular arrhythmia Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 271 at risk

Adverse event: Neuropathy: cranial CN II
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 271 at risk

Adverse event: Eye pain
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 271 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 271 at risk

Adverse event: Hemorrhage, GI Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Incontinence, anal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Perforation, GI Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Ulcer, GI Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Constitutional Symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Death Death NOS
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 271 at risk

Adverse event: Death Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 271 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 271 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 271 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 271 at risk

Adverse event: Gait/walking
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Infection (documented clinically) Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 271 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 271 at risk

Adverse event: Infection with normal ANC Bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 271 at risk

Adverse event: Infection with normal ANC Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with normal ANC Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Infection with unknown ANC Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 271 at risk

Adverse event: Infection with unknown ANC Skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 271 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 271 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 271 at risk

Adverse event: Thrombosis/embolism (vascular access)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 271 at risk

Adverse event: Blood antidiuretic hormone
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 271 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 271 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 271 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 271 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 271 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 271 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 271 at risk

Adverse event: Muscle weakness Extremity-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 271 at risk

Adverse event: Muscle weakness Extremity-upper
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 271 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 271 at risk

Adverse event: Muscle weakness Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 271 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pain Tumor pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 271 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 271 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 271 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 271 at risk

Adverse event: CNS necrosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 271 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Involuntary movement
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 271 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Neuropathy: cranial CN VIII
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pain Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 271 at risk

Adverse event: Pyramidal tract dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 20 affected / 271 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 20 affected / 271 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 21 affected / 271 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 23 affected / 271 at risk

Adverse event: Mood alteration Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 271 at risk

Adverse event: Mood alteration Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 271 at risk

Adverse event: Mood alteration Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 271 at risk

Adverse event: Personality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 271 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 271 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 271 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 271 at risk

Adverse event: Hemorrhage, GU Prostate
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 271 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 271 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 271 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 271 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Dermatology - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 271 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 271 at risk

Adverse event: Hearing (without monitoring program)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 14 affected / 271 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 271 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 271 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 271 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 271 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 271 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 271 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 35 affected / 271 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 147 affected / 271 at risk

Adverse event: Gait/walking
Serious: no
Organ System: General disorders
Frequency: 19 affected / 271 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 271 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 271 at risk

Adverse event: Muscle weakness Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 271 at risk

Adverse event: Muscle weakness Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 271 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 271 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 271 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 271 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 271 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 64 affected / 271 at risk

Adverse event: Neurology - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 271 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 65 affected / 271 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 271 at risk

Adverse event: Pain Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 78 affected / 271 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 271 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 271 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 77 affected / 271 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 271 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 65 affected / 271 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 271 at risk

Adverse event: Mood alteration Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 271 at risk

Adverse event: Mood alteration Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 271 at risk

Adverse event: Mood alteration Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 271 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 271 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 271 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 271 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 271 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 77 affected / 271 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 271 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 271 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 271 at risk