Study: NCT00419744

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 407 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 407 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 407 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 407 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 407 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 407 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 407 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 407 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 407 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 407 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 407 at risk

Adverse event: Abdominal hernia obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 407 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 407 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 407 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 407 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 407 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 407 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 407 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 407 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 407 at risk

Adverse event: Hepatitis A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 407 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 407 at risk

Adverse event: Lower respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 407 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 407 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 407 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 407 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 407 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 407 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 407 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 407 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 407 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 407 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 407 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 407 at risk

Adverse event: Mesothelioma malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 407 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 407 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 407 at risk

Adverse event: Thyroid adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 407 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 407 at risk

Adverse event: Anxiety disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 407 at risk

Adverse event: Renal aneurysm
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 407 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 407 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 407 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 407 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 407 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 407 at risk

Adverse event: Bronchial secretion retention
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 407 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 407 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 407 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 407 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 407 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 407 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 407 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 407 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 407 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 407 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 407 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 407 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 407 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 408 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 408 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 408 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Gastritis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Gastroduodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 408 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 408 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 408 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 408 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 408 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 408 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 408 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Lower respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 408 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 408 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 408 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 408 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 408 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 408 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 408 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 408 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 408 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 408 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 408 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 408 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 408 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 408 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 408 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 408 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 408 at risk

Adverse event: Laryngeal disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 408 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 408 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 408 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 408 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 408 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 408 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 408 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 408 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 408 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 408 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 408 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 408 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 403 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 403 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 403 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 403 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 403 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 403 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 403 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 403 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 403 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Enterocolitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 403 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Metastatic bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Non-small cell lung cancer stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Oesophageal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 403 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 403 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 403 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 403 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 403 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 403 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 403 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 403 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 403 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 403 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 403 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 403 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 403 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 403 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 403 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 403 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 403 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 403 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 403 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 68 affected / 403 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 403 at risk