TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00117663

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 527 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 527 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 527 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 527 at risk

Adverse event: Atypical Chest Pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 527 at risk

Adverse event: Other adverse event
Serious: no
Organ System: General disorders
Frequency: 8 affected / 527 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 462 at risk

Adverse event: Other adverse event
Serious: no
Organ System: General disorders
Frequency: 6 affected / 462 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 443 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 443 at risk
Study: NCT00117793

Adverse event: Device failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Socket fracture during routine activity preventing further use. Participant was wearing VASS at time of failure.
Frequency: 1 affected / 17 at risk
Study: NCT00117988

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 22 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 22 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 22 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 22 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk
Study: NCT00118352

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Concurrent elevated bilirubin. Patient expired
Frequency: 1 affected / 12 at risk

Adverse event: Death due to GVHD
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 12 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk
Study: NCT00118482

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 105 at risk
Study: NCT00118703

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 173 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 173 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 173 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 173 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 173 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 173 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 174 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 174 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 174 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 174 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 174 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 174 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 174 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 174 at risk
Study: NCT00119106

Adverse event: Any serious adverse event
Serious: yes
Organ System: Investigations
Frequency: 227 affected / 1204 at risk

Adverse event: AE
Serious: no
Organ System: Investigations
Notes: Other adverse events
Frequency: 1098 affected / 1204 at risk

Adverse event: Renal toxicity
Serious: no
Organ System: Renal and urinary disorders
Notes: NIH Grade 3 or 4
Frequency: 3 affected / 1204 at risk

Adverse event: Any serious adverse event
Serious: yes
Organ System: Investigations
Frequency: 246 affected / 1209 at risk

Adverse event: AE
Serious: no
Organ System: Investigations
Notes: Other adverse events
Frequency: 1083 affected / 1209 at risk

Adverse event: Renal toxicity
Serious: no
Organ System: Renal and urinary disorders
Notes: NIH Grade 3 or 4
Frequency: 3 affected / 1209 at risk
Study: NCT00119405

Adverse event: Pancreatitis (Grade 3)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 18 at risk

Adverse event: Right Lower Lobe (RLL) Pneumonia (Grade 3)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hypokalemia (Grade 2)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Incisional Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Incisional Hematoma (Grade 1)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Infected Incisional Hematoma (Grade 2)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Low glucose 34 (Grade 3)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Lab delay - repeated result was 105
Frequency: 1 affected / 18 at risk

Adverse event: Low glucose 48 (Grade 2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Tachycardia (Grade 2)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Bone Mineral Density (BMD)/T scores -2.3 and -3.2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Known osteoporosis pre-study
Frequency: 1 affected / 18 at risk

Adverse event: Elevated Aspartate aminotransferase (AST) (Grades 2 and 3)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 18 at risk

Adverse event: Elevated creatine kinase (CK) levels (Grades 3 and 4)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 18 at risk

Adverse event: Elevated alanine aminotransferase (ALT) 207 (Grade 2)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Elevated Cholesterol 257 (Grade 2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Elevated low-density lipoprotein (LDL) 175 (Grade 2)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Low absolute neutrophil count (ANC) (Grades 2 and 3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Low white blood cell (WBC) count (Grade 2)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk
Study: NCT00120406

Adverse event: Clinically-driven TLR (Target Lesion Revascularization)
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 235 at risk

Adverse event: Amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 235 at risk

Adverse event: Pneumonia requiring antibiotics
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 235 at risk

Adverse event: Post-procedure percutaneous intervention (e.g., PTA and/or stent) to the study vessel
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 235 at risk

Adverse event: Post-procedure percutaneous intervention (e.g., PTA and/or stent) to another vessel
Serious: no
Organ System: Vascular disorders
Frequency: 50 affected / 235 at risk

Adverse event: Worsened claudication/rest pain
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 235 at risk

Adverse event: Post-procedure transfusion
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 235 at risk

Adverse event: Clinically-driven TLR (Target Lesion Revascularization)
Serious: yes
Organ System: Vascular disorders
Frequency: 36 affected / 236 at risk

Adverse event: Worsening of Rutherford classification by 2 classes or to a class 5 or 6
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 236 at risk

Adverse event: Pneumonia requiring antibiotics
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 236 at risk

Adverse event: Post-procedure percutaneous intervention (e.g., PTA and/or stent) to the study vessel
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 236 at risk

Adverse event: Post-procedure percutaneous intervention (e.g., PTA and/or stent) to another vessel
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 236 at risk

Adverse event: Worsened claudication/rest pain
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 236 at risk

Adverse event: Post-procedure transfusion
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 236 at risk
Study: NCT00121173

Adverse event: Fatigue/tiredness, flu-like symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue/tiredness, flu-like symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue/tiredness, flu-like symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk
Study: NCT00121186

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

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

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

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

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

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT00121225

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vascular disorders - Other, specify
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: unrelated to study drug
Frequency: 1 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 32 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 32 at risk
Study: NCT00121251

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 17 at risk
Study: NCT00122278

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 106 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 106 at risk

Adverse event: Acute Medication Reactoin
Serious: no
Organ System: General disorders
Frequency: 10 affected / 106 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 9 affected / 106 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 99 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Acute Medication Reactoin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 12 affected / 99 at risk
Study: NCT00122369

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 76 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 76 at risk

Adverse event: Vomiting
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 76 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 82 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 82 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 78 at risk
Study: NCT00122447

Adverse event: Reaction to nitroglycerin during FMD test
Serious: no
Organ System: Cardiac disorders
Notes: During baseline FMD testing, prior to actually starting study medication, a vasavagal response to NTG was developed.
Frequency: 1 affected / 18 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pt was diagnosed with pancreatic cancer soon after enrollment, but before randomization to intervention group.
Frequency: 1 affected / 14 at risk
Study: NCT00122954

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 18 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Immune system disorders
Notes: subject report of multiple sclerosis relapse
Frequency: 3 affected / 18 at risk

Adverse event: cold or flu
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: Immune system disorders
Notes: subject reported as MS-related fatigue
Frequency: 3 affected / 18 at risk

Adverse event: numbness and tingling
Serious: no
Organ System: Nervous system disorders
Notes: MS related
Frequency: 2 affected / 18 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: cold or flu
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: prolonged menstruation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk
Study: NCT00123422

Adverse event: Cardiac Event
Serious: yes
Organ System: Cardiac disorders
Notes: Patients had chest pain or needed an intervention such as angioplasty.
Frequency: 1 affected / 35 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Patient developed a cellulitis in his legs
Frequency: 1 affected / 35 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of COPD that lasted over 2 weeks and caused the patient to be withdrawn from the study.
Frequency: 2 affected / 33 at risk

Adverse event: Cardiac Event
Serious: yes
Organ System: Cardiac disorders
Notes: Patients had chest pain or needed an intervention such as angioplasty.
Frequency: 3 affected / 35 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: A patient developed lung cancer during the study.
Frequency: 1 affected / 35 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient had a intercerebral bleed during the course of the study.
Frequency: 1 affected / 35 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of COPD that lasted over 2 weeks and caused the patient to be withdrawn from the study.
Frequency: 1 affected / 35 at risk