TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03888391

Adverse event: Trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 18 at risk

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

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 18 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

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

Adverse event: Frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 18 at risk

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

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

Adverse event: Apathy
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

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

Adverse event: Clenching teeth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk
Study: NCT03888755

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT03889197

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: serum sodium \< 130
Frequency: 2 affected / 43 at risk

Adverse event: Edema/Anasarca
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: As per identified by care giver physical exam.
Frequency: 1 affected / 43 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: As identified by clinician.
Frequency: 1 affected / 43 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: As identified by clinician.
Frequency: 1 affected / 43 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: participants with 2 consecutive serum sodium levels greater than 145
Frequency: 2 affected / 43 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: participants with 2 consecutive serum sodium measurements less than 135
Frequency: 5 affected / 43 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: post-NEC adhesions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 43 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: participants with 2 consecutive serum sodium levels greater than 145
Frequency: 4 affected / 43 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: participants with 2 consecutive serum sodium measurements less than 135
Frequency: 7 affected / 43 at risk
Study: NCT03889444

Adverse event: Intraocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 141 at risk

Adverse event: Cataract or lens opacities
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 141 at risk
Study: NCT03889756

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

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk

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

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

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

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

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

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

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system 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: Stress fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 2 at risk

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 2 at risk

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

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

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT03889886

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One subject was hospitalized for diverticulitis and recovered. The event was judged not related to treatment.
Frequency: 1 affected / 76 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: Category containing a number of different, minor eye conditions.
Frequency: 8 affected / 76 at risk

Adverse event: General Disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Installation site pain
Frequency: 6 affected / 76 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Intraocular pressure increased Vital dye staining cornea present
Frequency: 2 affected / 76 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: Category containing a number of different, minor eye conditions.
Frequency: 9 affected / 76 at risk

Adverse event: General Disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Installation site pain
Frequency: 5 affected / 76 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Intraocular pressure increased Vital dye staining cornea present
Frequency: 1 affected / 76 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: Category containing a number of different, minor eye conditions.
Frequency: 9 affected / 75 at risk

Adverse event: General Disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Installation site pain
Frequency: 10 affected / 75 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: Category containing a number of different, minor eye conditions.
Frequency: 16 affected / 69 at risk

Adverse event: General Disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Installation site pain
Frequency: 6 affected / 69 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Intraocular pressure increased Vital dye staining cornea present
Frequency: 1 affected / 69 at risk
Study: NCT03890289

Adverse event: Pyrexia, respiratory failure, cough
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia, diarrhea, Cytomegalovirus reativation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Transaminasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Sars-COV-2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: CMV reativation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT03890419

Adverse event: Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 6 affected / 34 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk
Study: NCT03890588

Adverse event: hospitalizations
Serious: yes
Organ System: General disorders
Frequency: 541 affected / 2923 at risk

Adverse event: Emergency Room Visits
Serious: no
Organ System: General disorders
Frequency: 1039 affected / 2923 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 202 affected / 1123 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 548 affected / 2923 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 853 affected / 2923 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 660 affected / 2923 at risk

Adverse event: hospitalizations
Serious: yes
Organ System: General disorders
Frequency: 543 affected / 3372 at risk

Adverse event: Emergency Room Visits
Serious: no
Organ System: General disorders
Frequency: 1100 affected / 3372 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 232 affected / 1263 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 814 affected / 3372 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1061 affected / 3372 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 847 affected / 3372 at risk
Study: NCT03890666

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: SARS-CoV-2 sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 166 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 150 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 150 at risk
Study: NCT03891199

Adverse event: Prosthetic Joint Infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT03891264

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT03891667

Adverse event: Short-term hospitalization
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Symptoms (severe abdominal pain) associated with elevated liver function tests led to a short-term hospitalization for evaluation. Episode probably related to a disulfiram reaction, but triggering exposure unclear; patient recovered.
Frequency: 1 affected / 5 at risk

Adverse event: Mild-moderately elevated liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 5 at risk

Adverse event: Mildly elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Moderate headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Moderate to severe sore throat/throat hoarseness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Moderate to severe hypersomnia/sleepiness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Moderate tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk

Adverse event: Moderate neuromotor weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Moderate photosensitivity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Moderate dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: ER visit
Serious: yes
Organ System: Immune system disorders
Notes: 10 days after ending disulfiram treatment early (due to headaches), an episode of throat tightness nausea and light-headedness occurred. The patient (hx of asthma) went to ER and was treated for emerging possible anaphylaxis and recovered.
Frequency: 1 affected / 4 at risk

Adverse event: Moderate shooting pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Moderate temperature fluctuations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk
Study: NCT03891862

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 132 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 132 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 132 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 132 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 132 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 132 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 132 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 132 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 132 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 59 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 59 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 59 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 59 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 59 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 59 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 59 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk
Study: NCT03892460

Adverse event: Pleuritic chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Pleuritic chest pain during functional stesting
Frequency: 1 affected / 30 at risk
Study: NCT03892616

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 16 at risk

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

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 14 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk

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

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

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

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk
Study: NCT03892707

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 250 at risk
Study: NCT03892889

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 277 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 277 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 277 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 277 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 277 at risk
Study: NCT03892915

Adverse event: death to fetus/newborn
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: miscarriage, abortion, stillbirth, neonatal death
Frequency: 13 affected / 191 at risk

Adverse event: death to fetus/newborn
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: miscarriage, abortion, stillbirth, neonatal death
Frequency: 18 affected / 200 at risk
Study: NCT03893396

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 143 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 143 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 143 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 294 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 294 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 294 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 546 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 546 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 546 at risk