Study: NCT00562302

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 170 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 170 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Chest pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 170 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 170 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Incision site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Pneumothorax traumatic
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Lung neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 170 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 170 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 170 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 170 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 170 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Bleeding at puncture site
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anticipated Adverse Device Effect
Frequency: 1 affected / 170 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 5 affected / 170 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 30 affected / 170 at risk

Adverse event: Pleural fluid
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 1 affected / 170 at risk

Adverse event: Chest pain with pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 7 affected / 170 at risk

Adverse event: Chest pain without pneumothorax
Serious: no
Organ System: Cardiac disorders
Notes: Anticipated Adverse Device Effect
Frequency: 9 affected / 170 at risk

Adverse event: Coughing with Blood
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 3 affected / 170 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 169 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 169 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 169 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 169 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 169 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 169 at risk

Adverse event: Chest pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 169 at risk

Adverse event: Energy increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Puncture site pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Lung neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 169 at risk

Adverse event: Malignant neoplasm progression
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 169 at risk

Adverse event: Malignant pleural effusion
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 169 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 169 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 169 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 169 at risk

Adverse event: Cachexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 169 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 169 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 169 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 169 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 169 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 169 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 169 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Pulmonary granuloma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: SUPERIOR VENA CAVAL OCCLUSION
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 169 at risk

Adverse event: Allergic reaction to anesthesia/drugs
Serious: no
Organ System: Immune system disorders
Notes: Anticipated Adverse Device Effect
Frequency: 1 affected / 169 at risk

Adverse event: Bleeding at puncture site
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anticipated Adverse Device Effect
Frequency: 1 affected / 169 at risk

Adverse event: Emphysema (subcutaneous)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 1 affected / 169 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 5 affected / 169 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 53 affected / 169 at risk

Adverse event: Pleural fluid
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 5 affected / 169 at risk

Adverse event: Chest pain with pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 13 affected / 169 at risk

Adverse event: Chest pain without pneumothorax
Serious: no
Organ System: Cardiac disorders
Notes: Anticipated Adverse Device Effect
Frequency: 11 affected / 169 at risk

Adverse event: Puncture site bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Anticipated Adverse Device Effect
Frequency: 2 affected / 169 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Anticipated Adverse Device Effect
Frequency: 1 affected / 169 at risk

Adverse event: Coughing with Blood
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 2 affected / 169 at risk

Adverse event: Altered lung function
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Anticipated Adverse Device Effect
Frequency: 1 affected / 169 at risk