TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02769624

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 14 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 14 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 14 at risk

Adverse event: Increase in Liver Lab Values
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 14 at risk

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

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

Adverse event: Blood pressure decreased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 15 at risk

Adverse event: Abnormal ECG Rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk
Study: NCT02769728

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: haemorrhoid bleeding
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Feeling bloated after gastroscopy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 10 at risk
Study: NCT02769858

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 10 at risk

Adverse event: Eyestrain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 10 at risk
Study: NCT02770248

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 60 at risk
Study: NCT02770287

Adverse event: Vaginal canal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain, biopsy site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Achy cramps, contractions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Blistering inside vaginal canal
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Feeling of 'blistering' inside vaginal canal
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk
Study: NCT02770521

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 8 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 13 at risk

Adverse event: Infusion site phlebitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 13 at risk

Adverse event: Infusion site phlebitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk
Study: NCT02770547

Adverse event: Surface level burn
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT02770625

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchitis / Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia viral / Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Ludwig angina
Serious: yes
Organ System: Cardiac disorders
Notes: Ludwig angina / Infections and infestations
Frequency: 1 affected / 8 at risk
Study: NCT02770820

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 7 at risk

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

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 7 at risk
Study: NCT02770846

Adverse event: Dental implant loss
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk
Study: NCT02771093

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

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

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

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk
Study: NCT02771145

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 180 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 180 at risk
Study: NCT02771197

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 20 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Right flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Non-neutropenic fever
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 20 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: General infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Cytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Radial fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk
Study: NCT02771275

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 13 at risk

Adverse event: Infection/Inflammation - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Arterial dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Damage to the native mitral valve apparatus Chord
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 13 at risk

Adverse event: Other Study Device Structural Problems
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 13 at risk

Adverse event: Pleural effusion - Left
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 13 at risk

Adverse event: Arrhythmia - Supraventricular Tachycardia (SVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 13 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Anemia - Non-bleeding related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Bleeding - Genitourinary - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: INFECTION - OTHER LOCALIZED INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Bone fracture/Break
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Other Access Site Complication - Minor
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 13 at risk

Adverse event: Renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MAJOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +4
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT02771340

Adverse event: Iridocyclitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Phototoxic Injury/Surgical Complication
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 3 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 5 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 5 at risk
Study: NCT02771366

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Concussion
Serious: no
Organ System: Nervous system disorders
Notes: Injury occurred outside of study
Frequency: 1 affected / 30 at risk

Adverse event: Stage 3 Kidney Failure
Serious: no
Organ System: Renal and urinary disorders
Notes: Participant had previous kidney problems before study began
Frequency: 1 affected / 30 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Swelling in legs and feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dazedness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Anger/Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Foot fracture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bowel blockage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk
Study: NCT02771522

Adverse event: non patient related adverse events
Serious: no
Organ System: Product Issues
Notes: Term from definition in ISO14155:2011 (E)

Device Deficiency - inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance
Frequency: 3 affected / 30 at risk
Study: NCT02771574

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk
Study: NCT02771795

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk
Study: NCT02772276

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk
Study: NCT02772302

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Notes: One serious, unexpected and unrelated adverse event was experienced, related to hypotension requiring IV fluid administration during EEG.
Frequency: 1 affected / 10 at risk
Study: NCT02772783

Adverse event: dizzyness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk
Study: NCT02773238

Adverse event: Pneumonitis Grade 3+
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: Esophagitis Grade 3+
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Pneumonitis Grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 51 at risk

Adverse event: Esophagitis Grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 51 at risk

Adverse event: Dermatitis Grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 51 at risk

Adverse event: Fatigue Grade 2
Serious: no
Organ System: General disorders
Frequency: 6 affected / 51 at risk