TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04435769

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Intracranial bleeding
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Muscle hematomas
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 67 at risk

Adverse event: Intracranial bleeding
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 67 at risk

Adverse event: GI bleeding
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Intraparenchymal hematoma of the lower lobe
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 67 at risk
Study: NCT04435795

Adverse event: Hospithalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE related to COVID-19, not to the study drug
Frequency: 6 affected / 105 at risk

Adverse event: Visit to the emergency department
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related to COVID-19, not to the study drug
Frequency: 1 affected / 105 at risk

Adverse event: Candida infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Severe headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 105 at risk

Adverse event: Voice change
Serious: no
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: throat irritaiton
Serious: no
Organ System: General disorders
Frequency: 7 affected / 105 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Dry nose, irritated nose or nosebleed
Serious: no
Organ System: General disorders
Frequency: 4 affected / 105 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 11 affected / 105 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 105 at risk

Adverse event: Hospithalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE related to COVID-19, not to the study drug
Frequency: 3 affected / 98 at risk

Adverse event: Visit to the emergency department
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related to COVID-19, not to the study drug
Frequency: 3 affected / 98 at risk

Adverse event: Severe headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Voice change
Serious: no
Organ System: General disorders
Frequency: 2 affected / 98 at risk

Adverse event: throat irritaiton
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 98 at risk

Adverse event: Dry nose, irritated nose or nosebleed
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 98 at risk

Adverse event: Wheezing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 98 at risk
Study: NCT04436120

Adverse event: Post procedural contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT04436796

Adverse event: Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 35 at risk

Adverse event: Medical device site haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 35 at risk
Study: NCT04437485

Adverse event: Blood pressure above the call order levels
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Blood pressure above the call order levels
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 22 at risk
Study: NCT04438499

Adverse event: Mild discomfort in the urethra
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild discomfort in the urethra following catheterization that was short lasting and resolved without intervention.
Frequency: 10 affected / 61 at risk

Adverse event: Mild macrohematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Small amount of blood when passing urine.
Frequency: 3 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Bleeding upon catheter removal
Serious: no
Organ System: Renal and urinary disorders
Notes: Mild bleeding upon removal of vesical (bladder) catheter
Frequency: 1 affected / 61 at risk
Study: NCT04439799

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Labyrithitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk
Study: NCT04439838

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

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

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

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

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

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

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

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 6 at risk

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

Adverse event: Vaccination complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT04439903

Adverse event: COVID positive
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk
Study: NCT04441255

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 14 at risk

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

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

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

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

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

Adverse event: Pain in extremity
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: 2 affected / 14 at risk

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

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pustule
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk
Study: NCT04441931

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

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

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

Adverse event: SARS-CoV-2 test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk
Study: NCT04441996

Adverse event: Mild tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk
Study: NCT04442230

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 23 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 23 at risk

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk
Study: NCT04442490

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 269 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 269 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 269 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 269 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 269 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 269 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 269 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 269 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 269 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 269 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 269 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 269 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Slow speech
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 268 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 268 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 268 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 268 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 268 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 268 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 268 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 268 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 268 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 268 at risk
Study: NCT04443218

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 220 at risk

Adverse event: Readmission - Cardiac (not Heart Failure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 220 at risk

Adverse event: Readmission - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 220 at risk

Adverse event: Atrial Septal Defect (ASD) Closure Due to Transseptal Catheterizaton
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 220 at risk

Adverse event: Bleeding at Access Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 220 at risk

Adverse event: Hematoma at Access Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 220 at risk

Adverse event: Major Vascular Complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 220 at risk

Adverse event: Other Device Related Event
Serious: yes
Organ System: Product Issues
Notes: Includes but is not limited to Single Leaflet Device Attachment events that occurred during follow-up.
Frequency: 3 affected / 220 at risk

Adverse event: Single Leaflet Device Attachment
Serious: yes
Organ System: Product Issues
Notes: Includes Single Leaflet Device Attachment events reported during procedure visit only. Single Leaflet Device Attachment events occurring during follow-up reported as Other Device Related Event.
Frequency: 1 affected / 220 at risk

Adverse event: New Requirement for Dialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 220 at risk

Adverse event: Complication Requiring Transcatheter or Surgical Intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 220 at risk

Adverse event: Mitral Valve Re-Intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 220 at risk

Adverse event: Readmission - Non-Cardiac (Follow Up)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 22 affected / 220 at risk

Adverse event: Unplanned Other Cardiac Surgery or Intervention (Not Mitral Valve Re-Intervention)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 220 at risk

Adverse event: Unplanned Vascular Surgery or Intervention (for Bleeding or Access Site Complication)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 220 at risk

Adverse event: Life-Threatening Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 220 at risk

Adverse event: Major Bleeding Event
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 220 at risk

Adverse event: Other Bleed
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 220 at risk
Study: NCT04445051

Adverse event: Possibly related
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary tract infection (UTI)
Frequency: 1 affected / 15 at risk
Study: NCT04445688

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 59 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 59 at risk