Study: NCT00238303

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 66 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 66 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Mucosal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 66 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 66 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 66 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 66 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Blood phosphorus decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood potassium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood sodium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Blood sodium increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 66 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 66 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 66 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 66 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 66 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 66 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 66 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 66 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 66 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 66 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 66 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 66 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 57 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 66 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 66 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 66 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Arterial injury - Extremity-lower
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 66 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 66 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 66 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 66 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 66 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 66 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 45 affected / 66 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 66 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 66 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 66 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 66 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 66 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 66 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood magnesium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 66 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 66 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 66 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 66 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Second primary malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 66 at risk

Adverse event: Accessory nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 66 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 66 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 66 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 66 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 66 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 66 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 66 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 66 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 66 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 66 at risk

Adverse event: Haemorrhage urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 66 at risk

Adverse event: Urogenital disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 66 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 66 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 66 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 66 at risk

Adverse event: Central nervous system necrosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 15 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 15 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 15 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 15 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 15 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 15 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Cerebral ischaemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 16 affected / 20 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Penile infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

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

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 20 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 20 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 20 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 20 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blood calcium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urogenital disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk