TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01473394

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 253 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 253 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 253 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 253 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 253 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 253 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 253 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 253 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 255 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 255 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 255 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 255 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 255 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 255 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 255 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 255 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 255 at risk
Study: NCT01473732

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: proteinuria
Frequency: 1 affected / 2 at risk

Adverse event: Small bowel obstruction leading to death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Small bowel obstruction lead to sepsis which lead to death
Frequency: 1 affected / 2 at risk
Study: NCT01474213

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk
Study: NCT01474317

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycemia events were non-serious (mild), non-device related, and anticipated.
Frequency: 3 affected / 224 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemic event was non-serious (mild), non-device related, and anticipated.
Frequency: 1 affected / 224 at risk
Study: NCT01474486

Adverse event: All Cause Mortality
Serious: yes
Organ System: Cardiac disorders
Notes: CHF exacerbation following Non-ST segment elevation myocardial infarction
Frequency: 1 affected / 22 at risk

Adverse event: All cause mortality
Serious: yes
Organ System: Cardiac disorders
Notes: Admitted into and expired at community hospital. Cause is unknown. Participant had contacted the VA within 3 days of his death complaining of excessive dizziness.
Frequency: 1 affected / 22 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Cardiac disorders
Notes: Inpatient hospitalization for pain caused by ischemia of right lower extremity. Second hospitalization for bifemoral bypass of the right lower extremity.
Frequency: 1 affected / 22 at risk

Adverse event: Serious Adverse Events
Serious: yes
Organ System: Infections and infestations
Notes: One inpatient hospitalization for wound dehiscence of L anterior ankle wound 9 months s/p L total ankle replacement. Second admission one month later for cellulitis of same area, followed by a 3rd hospitalization for same diagnoses 3 months later.
Frequency: 1 affected / 22 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Infections and infestations
Notes: Inpatient hospitalization for LLE cellulitis secondary to leg trauma.
Frequency: 1 affected / 22 at risk

Adverse event: Adverse Events
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Inpatient hospitalization for small bowel obstruction and ileus.
Frequency: 1 affected / 22 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization for bacteremia from a urinary source. Also had an obstructing urethral stone.
Frequency: 1 affected / 22 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: General disorders
Notes: Admitted for dehydration due to medication overuse.
Frequency: 1 affected / 22 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hospital admission for uncontrolled bleeding and anemia after lacerating his arm. This is the same participant as described in #5.
Frequency: 1 affected / 22 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Vascular disorders
Notes: Hospitalized for a Left Lower Extremity femoral bypass graft thrombosis. This occurred between consent and starting the intervention and is the same participant at #2.
Frequency: 1 affected / 22 at risk

Adverse event: Other
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Abnormal lab value
Frequency: 12 affected / 22 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 2 affected / 22 at risk

Adverse event: Other
Serious: no
Organ System: Eye disorders
Notes: Conjunctivitis
Frequency: 2 affected / 22 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Flu-like symptoms
Frequency: 2 affected / 22 at risk
Study: NCT01474551

Adverse event: Creatinine increase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT01474590

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 133 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 133 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 133 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 133 at risk

Adverse event: naospharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 133 at risk

Adverse event: UPTRI (Upper Tract Respiratory Infection)
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 133 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 133 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 133 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 133 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: naospharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 133 at risk

Adverse event: UPTRI (Upper Tract Respiratory Infection)
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 133 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 133 at risk
Study: NCT01474863

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death
Frequency: 5 affected / 26 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death
Frequency: 5 affected / 22 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death
Frequency: 3 affected / 24 at risk
Study: NCT01474915

Adverse event: Cerebrovascular Hematoma
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated cerebrovascular hematoma resulting in additional surgical procedure for evacuation
Frequency: 2 affected / 60 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Unrelated fever resulting in re-hospitalization
Frequency: 1 affected / 61 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Unrelated deep vein thrombosis resulting in prolonged hospitalization
Frequency: 1 affected / 61 at risk

Adverse event: Cerebrospinal fluid leak
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated cerebrospinal fluid leak resulting in additional procedure
Frequency: 1 affected / 61 at risk
Study: NCT01475097

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 127 at risk

Adverse event: Vessel puncture site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 127 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hemorrhage from femoral common artery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk
Study: NCT01475136

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT01475162

Adverse event: Elevated alanine aminotransferase Grade 3
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Adult respiratory distress syndrome Grade 5
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhea Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhea Grade 4
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sepsis Grade 5
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 13 at risk

Adverse event: Sepsis Grade 4
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 13 at risk

Adverse event: Presyncope Grade 1
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Bronchial infection Grade 3
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Enterocolitis Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pneumothorax Grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Respiratory failure Grade 4
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Multi-organ failure Grade 5
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Blood and lymphatic system disorders - Other Grade 5
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Adult respiratory distress syndrome Grade 4
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT01475331

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Notes: acute pancreatitis after ablation of 20-mm tail cyst requiring a 36- hour hospital stay
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: abdominal pain requiring unscheduled clinical evaluation and treatment for pain control
Frequency: 4 affected / 18 at risk
Study: NCT01475474

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 91 at risk

Adverse event: Accidental Bowel Leakage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 91 at risk

Adverse event: Anorectal Bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 91 at risk

Adverse event: Anorectal Irritation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 91 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 91 at risk

Adverse event: Anorectal Soreness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 91 at risk

Adverse event: Anorectal Urge
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 91 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 91 at risk

Adverse event: Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 91 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 91 at risk

Adverse event: Device Displacement
Serious: no
Organ System: General disorders
Frequency: 21 affected / 91 at risk
Study: NCT01475734

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk
Study: NCT01476202

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausae
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk
Study: NCT01476267

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT01476345

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Procedural site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 80 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Procedural site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 80 at risk
Study: NCT01476449

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Suspected MI
Frequency: 1 affected / 10 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk