Study: NCT01061671

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 433 at risk

Adverse event: Respiratory Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 433 at risk

Adverse event: Bone neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 433 at risk

Adverse event: Genitourinary Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 433 at risk

Adverse event: Neuroendocrine Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 433 at risk

Adverse event: Metabolic disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 433 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 433 at risk

Adverse event: Central Nervous System disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 433 at risk

Adverse event: Rheumatic heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 433 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 433 at risk

Adverse event: Pulmonary Circulation disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 433 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 433 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 433 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 433 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 433 at risk

Adverse event: Cerebrovascular
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 433 at risk

Adverse event: Artery disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 433 at risk

Adverse event: Vein disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 433 at risk

Adverse event: Acute Respiratory Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 433 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 433 at risk

Adverse event: Influenza
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 433 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 433 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 96 affected / 433 at risk

Adverse event: COPD other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 433 at risk

Adverse event: Other Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 433 at risk

Adverse event: Esophagus and stomach disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 433 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 433 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 433 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 433 at risk

Adverse event: Other Intestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 433 at risk

Adverse event: Other Digestive Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 433 at risk

Adverse event: Nephrotic disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 433 at risk

Adverse event: Other Urinary Disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 433 at risk

Adverse event: Disorders of the Female Genitourinary System
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 433 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 433 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 433 at risk

Adverse event: Back disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 433 at risk

Adverse event: Rheumatic disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 433 at risk

Adverse event: Bone disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 433 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 433 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 433 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 433 at risk

Adverse event: Severe Headaches
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 433 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 433 at risk

Adverse event: Ill defined abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 433 at risk

Adverse event: Sudden death of unknown cause
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 433 at risk

Adverse event: Fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 433 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 433 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 433 at risk

Adverse event: Internal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 433 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 433 at risk

Adverse event: Trauma from motorcycle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 433 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 433 at risk

Adverse event: Complications of surgical and medical care
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 433 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 433 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 433 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 433 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 433 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 433 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 433 at risk

Adverse event: Ill Defined Respiratory events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 433 at risk

Adverse event: Ill defined digestive symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 433 at risk

Adverse event: Acute Respiratory Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 109 affected / 433 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 433 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 232 affected / 433 at risk

Adverse event: Other COPD Related Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 433 at risk

Adverse event: Arthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 433 at risk

Adverse event: Dorsopathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 433 at risk

Adverse event: Rheumatic disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 433 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 433 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 16 affected / 433 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 433 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Other Infection
Serious: yes
Organ System: Infections and infestations
Notes: Pulmonary Aspergillosis
Frequency: 1 affected / 452 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Liver Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Respiratory Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 452 at risk

Adverse event: Bone neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 452 at risk

Adverse event: Genitourinary Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 452 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Lymphatic Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Neuroendocrine Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 452 at risk

Adverse event: Metabolic disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 452 at risk

Adverse event: Cavernous Hemangioma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 452 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 452 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 452 at risk

Adverse event: Pulmonary Circulation disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 452 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 452 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 452 at risk

Adverse event: Cerebrovascular
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 452 at risk

Adverse event: Artery disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 452 at risk

Adverse event: Vein disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 452 at risk

Adverse event: Acute Respiratory Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 452 at risk

Adverse event: Influenza
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 452 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pneumoconioses
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 97 affected / 452 at risk

Adverse event: COPD other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 452 at risk

Adverse event: Other Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 452 at risk

Adverse event: Esophagus and stomach disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 452 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Other Intestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 452 at risk

Adverse event: Other Digestive Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 452 at risk

Adverse event: Other Urinary Disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 452 at risk

Adverse event: Disorders of the Male Genitourinary System
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 452 at risk

Adverse event: Disorders of the Female Genitourinary System
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 452 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 452 at risk

Adverse event: Back disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 452 at risk

Adverse event: Rheumatic disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Bone disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Oesophagogastric fundoplasty
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Ill defined abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Sudden death of unknown cause
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 452 at risk

Adverse event: Fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 452 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Internal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Complications of surgical and medical care
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 452 at risk

Adverse event: Ill Defined Respiratory events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 452 at risk

Adverse event: Ill defined digestive symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 452 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Acute Respiratory Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 107 affected / 452 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 452 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 244 affected / 452 at risk

Adverse event: Other COPD Related Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 452 at risk

Adverse event: Arthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 452 at risk

Adverse event: Dorsopathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 452 at risk

Adverse event: Rheumatic disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 54 affected / 452 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 452 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 23 affected / 452 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 452 at risk