Study: NCT01006616

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Mallory-Weiss syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Megacolon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 152 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 152 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 152 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 152 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Oral neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 152 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 152 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 152 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 152 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Arterial bypass operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 152 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 152 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 152 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 152 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 152 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 152 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 152 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 152 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 152 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 156 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 156 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 156 at risk

Adverse event: Cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 156 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 156 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Infective exacerbation of chronic obstructive airways disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 156 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Facial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 156 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 156 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 156 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Arterial disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 156 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 156 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 156 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 156 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 156 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 156 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 156 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 156 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 152 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 152 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 152 at risk

Adverse event: Scrotal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 152 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Renal cancer stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 152 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 152 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 152 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 152 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 152 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 152 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 152 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 152 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 152 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 152 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 152 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 152 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 154 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 154 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 154 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Blood urea increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Tenosynovitis stenosans
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 154 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 154 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 154 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pulmonary cavitation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Prostatectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 154 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 154 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 154 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 154 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 154 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 154 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 154 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 154 at risk