TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01211665

Adverse event: Progressive multifocal leukoencephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Skin haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Progressive multifocal leukoencephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: Immune reconstitution inflammatory syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Progressive multifocal leukoencephalopathy
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1 at risk
Study: NCT01211730

Adverse event: death within 1 year of transplant
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Deaths occurring within one year of transplant
Frequency: 5 affected / 82 at risk

Adverse event: Readmission within one year
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hospital readmission within one year
Frequency: 48 affected / 82 at risk

Adverse event: Infections within one year of transplant
Serious: no
Organ System: Infections and infestations
Notes: Infection in any organ within one year of transplant
Frequency: 35 affected / 82 at risk

Adverse event: Liver Graft Failure within 1 year of transplant
Serious: no
Organ System: Hepatobiliary disorders
Notes: Failure of the Liver graft within 1 year of transplant
Frequency: 5 affected / 82 at risk

Adverse event: death within 1 year of transplant
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Deaths occurring within one year of transplant
Frequency: 5 affected / 82 at risk

Adverse event: Readmission within one year
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hospital readmission within one year
Frequency: 51 affected / 82 at risk

Adverse event: Infections within one year of transplant
Serious: no
Organ System: Infections and infestations
Notes: Infection in any organ within one year of transplant
Frequency: 54 affected / 82 at risk

Adverse event: Liver Graft Failure within 1 year of transplant
Serious: no
Organ System: Hepatobiliary disorders
Notes: Failure of the Liver graft within 1 year of transplant
Frequency: 8 affected / 82 at risk
Study: NCT01211769

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT01211873

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 240 at risk

Adverse event: Extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 240 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 240 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 240 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 240 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 240 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 240 at risk

Adverse event: Small intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: not related
Frequency: 1 affected / 117 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 117 at risk

Adverse event: Extravasation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 117 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: not related
Frequency: 1 affected / 38 at risk

Adverse event: Neurological decompensation
Serious: yes
Organ System: Nervous system disorders
Notes: not related
Frequency: 1 affected / 38 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk
Study: NCT01212159

Adverse event: Motor vehicle accident, minor musculoskeletal injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject seen in emergency department after MVA, analgesic therapy prescribed for 4 days.
Frequency: 1 affected / 26 at risk

Adverse event: Hodgkins lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subject noted to have lymphadenopathy during study period. Evaluation by hematology diagnosed Hodgkin's lymphoma and instituted therapy. Subject withdrew from study before completion.
Frequency: 1 affected / 44 at risk
Study: NCT01212172

Adverse event: Thermal burn
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Thermal burn
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk
Study: NCT01212484

Adverse event: lightheadedness / faint
Serious: yes
Organ System: Nervous system disorders
Notes: Patient reported feeling lightheaded and fainted. Blood results indicated patient was anemic and volume depleted, a common feature of FD patients. Patient had a history of dehydration. Patient was hospitalized and recovered without sequelae.
Frequency: 1 affected / 12 at risk
Study: NCT01213043

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This study used the American Thoracic Society (ATS)/European Respiratory Society (ERS) Task Force definition of exacerbation.
Frequency: 7 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This study used the American Thoracic Society (ATS)/European Respiratory Society (ERS) Task Force definition of exacerbation.
Frequency: 5 affected / 30 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 30 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk
Study: NCT01213082

Adverse event: Mild retinal vasculopathy possible radiation retinopathy
Serious: no
Organ System: Eye disorders
Notes: as accessed at month 24
Frequency: 1 affected / 4 at risk

Adverse event: Mild retinal vasculopathy possible radiation retinopathy
Serious: no
Organ System: Eye disorders
Notes: as accessed at month 24
Frequency: 2 affected / 6 at risk
Study: NCT01213173

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Genital neoplasm malignant female
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 112 at risk
Study: NCT01213264

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 155 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 155 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 155 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 155 at risk

Adverse event: bradyarrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 177 at risk

Adverse event: Type I hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 177 at risk

Adverse event: Airway peak pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 177 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 177 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 177 at risk

Adverse event: Flushing
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 177 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 177 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 177 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 177 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 177 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 327 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 327 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 327 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 327 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 327 at risk
Study: NCT01213524

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: self-report, not related
Frequency: 1 affected / 37 at risk

Adverse event: Alcohol detoxification
Serious: no
Organ System: Nervous system disorders
Notes: self-report, not related
Frequency: 1 affected / 37 at risk

Adverse event: suicidality
Serious: no
Organ System: Psychiatric disorders
Notes: self-report, not related
Frequency: 1 affected / 37 at risk

Adverse event: fall requiring stitches
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: self-report, not related
Frequency: 1 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: self-report, not related
Frequency: 1 affected / 38 at risk

Adverse event: car accident
Serious: no
Organ System: Social circumstances
Notes: self-report, not related
Frequency: 1 affected / 38 at risk
Study: NCT01213576

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: joint pains
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: abdominal pains
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 17 at risk

Adverse event: joint pains
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: abdominal pains
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 18 at risk

Adverse event: joint pains
Serious: no
Organ System: General disorders
Frequency: 3 affected / 18 at risk

Adverse event: abdominal pains
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: joint pains
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: abdominal pains
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk
Study: NCT01213589

Adverse event: Pulmonary Complications (General)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 50 at risk

Adverse event: Cardiac and Hemodynamic (General)
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 50 at risk

Adverse event: GI (General)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 50 at risk

Adverse event: Arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 50 at risk

Adverse event: Renal Complications (General)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pulmonary Complications (General)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Cardiac and Hemodynamic (General)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 24 at risk

Adverse event: GI (General)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 24 at risk

Adverse event: Renal Complications (General)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 24 at risk

Adverse event: Pulmonary Complications (General)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Cardiac and Hemodynamic (General)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 26 at risk

Adverse event: GI (General)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 26 at risk

Adverse event: Renal Complications (General)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk
Study: NCT01213836

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: heart rate increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 62 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk
Study: NCT01214044

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: One subject reported the onset of a headache around 6 pm with subsequent feelings of her heart racing, feeling flushed in her face \& neck and some itchiness. The symptoms resolved after 2 hours.
Frequency: 1 affected / 17 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: In this cohort of subjects with mild to severe Major Depressive Disorder, one subject was admitted to an outside hospital following a suicide attempt and was subsequently transferred to outpatient facility for ongoing treatment.
Frequency: 1 affected / 14 at risk
Study: NCT01214083

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 4 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk
Study: NCT01214161

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: patient was dizzy during the procedure
Frequency: 9 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: patients had some nausea during the procedure (IUD insertion)
Frequency: 8 affected / 100 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: patient was dizzy during the procedure
Frequency: 12 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: patients had some nausea during the procedure (IUD insertion)
Frequency: 4 affected / 100 at risk
Study: NCT01214174

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 13 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 2 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 16 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 13 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 13 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 5 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01214200

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 9 at risk