Study: NCT00868166

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 259 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 259 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 259 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 259 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 259 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 259 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Bronchial secretion retention
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Nocturnal dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 259 at risk

Adverse event: Gastrointestinal fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Chest injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Poisoning deliberate
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Traumatic intracranial haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 259 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 259 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 259 at risk

Adverse event: Pelvic venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 259 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 259 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 259 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 259 at risk

Adverse event: Meningorrhagia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 259 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Application site inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 259 at risk

Adverse event: Application site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 259 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 259 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 259 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 259 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 259 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 259 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 259 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 259 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 259 at risk

Adverse event: Tongue neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 259 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 259 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 259 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 259 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 259 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 259 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 259 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 259 at risk

Adverse event: Mechanical ventilation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 259 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 259 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 259 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 259 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 259 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 259 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 259 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 259 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 26 affected / 259 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 259 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 259 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 259 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 253 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 253 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 253 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 253 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 253 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Increased bronchial secretion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 253 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Hypoventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Respiratory tract congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 253 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 253 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 253 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 253 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 253 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 253 at risk

Adverse event: Face injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 253 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 253 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 253 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 253 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 253 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 253 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 253 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Areflexia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 253 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 253 at risk

Adverse event: Sleep disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 253 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 253 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 253 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 253 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 253 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: Alcoholic liver disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 253 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 253 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 253 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 253 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 253 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 253 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 253 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 253 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 253 at risk