Study: NCT00915278

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vaginal cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Prothrombin time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Urinary tract infection pseudomonal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary bladder haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Paranasal sinus hypersecretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 9 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 9 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 9 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Spider naevus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk