Study: NCT00337779

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 586 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 586 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 586 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 586 at risk

Adverse event: Swollen tongue
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 586 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 586 at risk

Adverse event: Chillls
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 586 at risk

Adverse event: Palatal oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 586 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 586 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 586 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 586 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 586 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Notes: Fungal Infection
Frequency: 1 affected / 586 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 586 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 586 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 586 at risk

Adverse event: Complicated fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 586 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 586 at risk

Adverse event: Chondropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthropathy
Frequency: 1 affected / 586 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 586 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 586 at risk

Adverse event: Fibroadenoma of breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Breast Neoplasm
Frequency: 1 affected / 586 at risk

Adverse event: Metastases to lymph nodes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 586 at risk

Adverse event: Tension headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 586 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 586 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 586 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Notes: Agitation
Frequency: 1 affected / 586 at risk

Adverse event: Neophrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 586 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 586 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Laparoscopy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Breast conserving surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Oophorectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Spinal laminectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Varicose vein operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 586 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 586 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 586 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Asthenia
Frequency: 39 affected / 586 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 32 affected / 586 at risk

Adverse event: Injection Erythema
Serious: no
Organ System: General disorders
Frequency: 183 affected / 586 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 31 affected / 586 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Notes: Injection Site Inflamation
Frequency: 57 affected / 586 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Injection Site Mass
Frequency: 46 affected / 586 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 53 affected / 586 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Injection Site Oedema
Frequency: 47 affected / 586 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 109 affected / 586 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 90 affected / 586 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 30 affected / 586 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 586 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Pharyngitis
Frequency: 78 affected / 586 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 586 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 586 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 586 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 586 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 44 affected / 586 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Vasodilatation
Frequency: 26 affected / 586 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 586 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 569 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 569 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 569 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 569 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 569 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 569 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 569 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 569 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 569 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 569 at risk

Adverse event: Chillls
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 569 at risk

Adverse event: Face oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 569 at risk

Adverse event: Swelling face
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 569 at risk

Adverse event: Biliary Dyskinesai
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Gallbladder Disorder
Frequency: 1 affected / 569 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 569 at risk

Adverse event: Hypersensititvity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 569 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 569 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 569 at risk

Adverse event: Crush injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 569 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 569 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Investigations
Notes: Diagnostic Procedure
Frequency: 1 affected / 569 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Notes: Laboratory Abnormal
Frequency: 1 affected / 569 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 569 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 569 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 569 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 569 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 1 affected / 569 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 569 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 569 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Neuropathy Peripheral
Frequency: 1 affected / 569 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 569 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope
Frequency: 1 affected / 569 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 569 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 569 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 569 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 569 at risk

Adverse event: Coronary arterial stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 569 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 1 affected / 569 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 569 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 569 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Asthenia
Frequency: 41 affected / 569 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 28 affected / 569 at risk

Adverse event: Injection Erythema
Serious: no
Organ System: General disorders
Frequency: 196 affected / 569 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 21 affected / 569 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Notes: Injection Site Inflamation
Frequency: 42 affected / 569 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Injection Site Mass
Frequency: 54 affected / 569 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 63 affected / 569 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Injection Site Oedema
Frequency: 55 affected / 569 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 99 affected / 569 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 93 affected / 569 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 19 affected / 569 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 569 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Pharyngitis
Frequency: 74 affected / 569 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 569 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 569 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 569 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 569 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 569 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Vasodilatation
Frequency: 36 affected / 569 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 569 at risk