TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02275923

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Notes: Patient presented to the Alfred Hospital with headache, fever and photophobia. Following admission and assessment he was diagnosed with conjunctivitis and discharged on the 28th July.
Frequency: 1 affected / 7 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Renal and urinary disorders
Notes: Post dialysis on the 20.01.15, a thrombosed AVF was diagnosed post ultrasound and was admitted to the Alfred Hospital for a planned fistulagram and plasty. He then required an extra dialysis session.
Frequency: 1 affected / 7 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient presented to Emergency with worsening abdominal pain. A abdominal CT scan showed ischemic bowel and an evolving small bowel obstruction. The subject underwent a laparotomy and small bowel resection.
Frequency: 1 affected / 7 at risk

Adverse event: Application site anaesthesia
Serious: no
Organ System: Surgical and medical procedures
Notes: Pt has complained of mild numbness and very occasional discomfort at the implant site since 11.04.15. R/w by Dr Scott Wilson and nil signs of infection or cause for concern. Patient happy to continue.
Frequency: 1 affected / 7 at risk
Study: NCT02276053

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 93 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 93 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 93 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 93 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 93 at risk
Study: NCT02276066

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: readmitted with a chief complaint of abdominal pain
Frequency: 5 affected / 41 at risk

Adverse event: Colostomy closure
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Readmission for colostomy reversal
Frequency: 1 affected / 41 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Readmission for wound care
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Esophagael surgery
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 41 at risk

Adverse event: C. Diff infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: readmitted with a chief complaint of abdominal pain
Frequency: 3 affected / 32 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Readmission for wound care
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Readmission for pacemaker implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Readmission for planned angiogram
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Cholecystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

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

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

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk
Study: NCT02276482

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 91 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 91 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 91 at risk
Study: NCT02276547

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 27 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Vascular Access Site and Access Related Complications
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 27 at risk

Adverse event: Arrhythmia and Conduction System Disturbances
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Progression of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 27 at risk

Adverse event: Decreased Ejection Fraction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Infection - Not related to Study Device/Procedure
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 27 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Multi System Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Valve Migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Notes: No symptoms reported. Troponin increase and ECG changes noted meeting protocol definition. Adjudicated by the CEC as non serious
Frequency: 1 affected / 27 at risk

Adverse event: Pre Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adjudicated by the CEC as non serious
Frequency: 2 affected / 27 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adjudicated by the CEC as non serious
Frequency: 1 affected / 27 at risk
Study: NCT02276560

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

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

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

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

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

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

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

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

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

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

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT02276807

Adverse event: Hospitalization Due to Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 68 at risk

Adverse event: Hospitalization due to
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 68 at risk

Adverse event: Hospitalization due to Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Hospitalization due to Psychiatric Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 68 at risk

Adverse event: Outpatient Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 68 at risk

Adverse event: Clinically Significant Increase in Depressive Symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Greater than 9 point increase on total score on the PHQ-9
Frequency: 4 affected / 68 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 68 at risk

Adverse event: Distressed Participant Unrelated to Study
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hospitalization Due to Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 72 at risk

Adverse event: Hospitalization due to
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 72 at risk

Adverse event: Outpatient Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 72 at risk

Adverse event: Clinically Significant Increase in Depressive Symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Greater than 9 point increase on total score on the PHQ-9
Frequency: 1 affected / 72 at risk

Adverse event: Emergency Room Visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 72 at risk
Study: NCT02276963

Adverse event: Headache/body ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk
Study: NCT02277028

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: A hospitalization was required that was not related to research protocol or the body system that the research was addressing.
Frequency: 1 affected / 8 at risk
Study: NCT02277106

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 17 at risk
Study: NCT02277444

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Herpes zoster disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Infective exacerbation of bronchiectasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Cutaneous T-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 127 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 127 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 127 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 127 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 127 at risk
Study: NCT02277548

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Elevated creatinine, changed to non-qualifying chemotherapy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk
Study: NCT02277665

Adverse event: Pruritus
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 33 at risk

Adverse event: Pruritus
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 34 at risk
Study: NCT02277925

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 99 at risk

Adverse event: Ureteric injury
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 101 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Port site hernia
Serious: yes
Organ System: Surgical and medical procedures
Notes: Port site hernia requiring surgery
Frequency: 1 affected / 101 at risk

Adverse event: Infected hematoma
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 101 at risk
Study: NCT02278211

Adverse event: Beta-blocker induced bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Admitted with heart failure to CCU, exacerbated by beta blocker
Frequency: 1 affected / 704 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: Subject admitted to hospital with palpitations following caffeine intake
Frequency: 1 affected / 704 at risk

Adverse event: Contrast reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Contrast reaction
Frequency: 8 affected / 704 at risk

Adverse event: Cannula access site
Serious: no
Organ System: Product Issues
Notes: Cannula access site
Frequency: 5 affected / 704 at risk
Study: NCT02278263

Adverse event: Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Infection
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Infection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 51 at risk
Study: NCT02278328

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: hungry / thirsty
Frequency: 1 affected / 23 at risk

Adverse event: overly energetic
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: cold symptoms / upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: stuffy nose, sore throat, coughing, sneezing
Frequency: 4 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Notes: hungry / thirsty
Frequency: 2 affected / 23 at risk

Adverse event: overly energetic
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: cold symptoms / upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: stuffy nose, sore throat, coughing, sneezing
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: overly energetic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk
Study: NCT02278354

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

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT02278367

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 69 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 110 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 110 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 110 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Injection site coldness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 110 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 110 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 110 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 110 at risk

Adverse event: Procedural headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Loss of bladder sensation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 110 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk
Study: NCT02278471

Adverse event: stroke-related death
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 155 at risk

Adverse event: death from motor vehicle accident
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 155 at risk

Adverse event: Coronary Artery Bypass Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 155 at risk

Adverse event: non-CV death
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 148 at risk

Adverse event: non-CV death
Serious: yes
Organ System: Hepatobiliary disorders
Notes: alcohol toxicity
Frequency: 1 affected / 148 at risk