TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02697006

Adverse event: Bleeding event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 34 at risk

Adverse event: Wound infection groin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Deterioration in bispectral index
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 34 at risk

Adverse event: Coronary artery perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Syncope/Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Colonic impaction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 13 at risk

Adverse event: Lower leg ischemia due to arterial clot
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 13 at risk
Study: NCT02697188

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: frontal headache
Frequency: 1 affected / 12 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: runny nose/ sinus congestion/stuffy nose/ nasal congestion/ sneezing/ cough
Frequency: 1 affected / 12 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: runny nose/ sinus congestion/stuffy nose/ nasal congestion/ sneezing/ cough
Frequency: 2 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: anemia/low hemoglobin/ low hematocrit
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: frontal headache
Frequency: 2 affected / 12 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: runny nose/ sinus congestion/stuffy nose/ nasal congestion/ sneezing/ cough
Frequency: 3 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: frontal headache
Frequency: 1 affected / 12 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: runny nose/ sinus congestion/stuffy nose/ nasal congestion/ sneezing/ cough
Frequency: 4 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: runny nose/ sinus congestion/stuffy nose/ nasal congestion/ sneezing/ cough
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: anemia/low hemoglobin/ low hematocrit
Frequency: 1 affected / 12 at risk
Study: NCT02697240

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk
Study: NCT02697292

Adverse event: Encephalitis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk
Study: NCT02697448

Adverse event: Post-Operative Nausea and/or Vomiting
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 62 at risk

Adverse event: Post-Operative Nausea and/or Vomiting
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 63 at risk
Study: NCT02697617

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 18 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 18 at risk

Adverse event: gastrointestinal symptom
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 18 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 18 at risk

Adverse event: urinary tract infection or pain
Serious: no
Organ System: General disorders
Notes: or cyst rupture
Frequency: 7 affected / 18 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Hepatobiliary disorders
Notes: pancreatitis
Frequency: 1 affected / 18 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: elective surgery/gastric banding
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 18 at risk

Adverse event: gastrointestinal symptom
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 18 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 18 at risk

Adverse event: urinary tract infection or pain
Serious: no
Organ System: General disorders
Notes: or cyst rupture
Frequency: 9 affected / 18 at risk
Study: NCT02697916

Adverse event: Non-Fatal MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 228 affected / 7434 at risk

Adverse event: Non-Fatal Stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 102 affected / 7434 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Cardiac disorders
Notes: Major Bleeding requiring transfusion
Frequency: 53 affected / 7434 at risk

Adverse event: PCI or CABG
Serious: no
Organ System: Cardiac disorders
Frequency: 471 affected / 7434 at risk

Adverse event: Transient ischemia attack (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 7434 at risk

Adverse event: Non-Fatal MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 213 affected / 7330 at risk

Adverse event: Non-Fatal Stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 92 affected / 7330 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Cardiac disorders
Notes: Major Bleeding requiring transfusion
Frequency: 44 affected / 7330 at risk

Adverse event: PCI or CABG
Serious: no
Organ System: Cardiac disorders
Frequency: 446 affected / 7330 at risk

Adverse event: Transient ischemia attack (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 7330 at risk
Study: NCT02698566

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk
Study: NCT02698826

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 16 at risk

Adverse event: Poor neurological outcome
Serious: yes
Organ System: Nervous system disorders
Notes: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance or Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Frequency: 1 affected / 16 at risk
Study: NCT02698865

Adverse event: Mitral valve prolapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 140 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 140 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 140 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 80 at risk
Study: NCT02699086

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

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

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

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

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

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

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

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

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

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue 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: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

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

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

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

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

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

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

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

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT02699463

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 115 at risk

Adverse event: exacerbation of pre-existing condition
Serious: no
Organ System: General disorders
Frequency: 2 affected / 115 at risk

Adverse event: virus
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 115 at risk

Adverse event: hospitalization for dizziness, existing cardiac condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: symptoms of transient ischemic attack (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: exacerbation of pre-existing condition
Serious: no
Organ System: General disorders
Frequency: 8 affected / 118 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 118 at risk

Adverse event: physical accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 118 at risk

Adverse event: virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk
Study: NCT02699684

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk
Study: NCT02699866

Adverse event: Implant lost
Serious: no
Organ System: Surgical and medical procedures
Notes: Implant lost on pos. 22, subject discontinued.
Frequency: 3 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk
Study: NCT02699892

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 130 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 130 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 130 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 130 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 130 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 130 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 130 at risk
Study: NCT02700165

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hip replacement performed during study period. Unrelated to study device or procedure.
Frequency: 1 affected / 14 at risk

Adverse event: Rash on face and neck
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild rash. Not related to device or procedure.
Frequency: 1 affected / 14 at risk

Adverse event: Ear pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Mild ear pain beginning day of treatment; resolved in 5 days. Possibly related to device or procedure.
Frequency: 1 affected / 14 at risk

Adverse event: Tongue tingling
Serious: no
Organ System: General disorders
Notes: Mild tongue tingling resolved within 7 days. Possibly related to device or procedure.
Frequency: 1 affected / 14 at risk
Study: NCT02700334

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Edema in upper extremities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Edema in upper extremities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT02700425

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Transient ischemic attack with aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: atrial lead microdislodgment
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 19 at risk
Study: NCT02700529

Adverse event: Supraventricular tachycardia /
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Adnexal torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk
Study: NCT02700815

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 75 at risk

Adverse event: Burning sensation
Serious: no
Organ System: General disorders
Frequency: 16 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 223 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 223 at risk

Adverse event: Burning sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 223 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 223 at risk

Adverse event: Burning sensation
Serious: no
Organ System: General disorders
Frequency: 12 affected / 225 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 225 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 225 at risk
Study: NCT02700841

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 4 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 4 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT02701062

Adverse event: Torsion of the heart
Serious: yes
Organ System: Cardiac disorders
Notes: Unanticipated severe event that occurred post-placement, before discharge. Related to surgical technical phenomenon \& the AtriClip application procedure. Medication administered \& heart was untwisted during index procedure. Resolved without sequelae.
Frequency: 1 affected / 376 at risk

Adverse event: Acute Post Pericardotomy Syndrome
Serious: no
Organ System: Cardiac disorders
Notes: Mild event that occurred post-placement, before discharge. Possibly related to the AtriClip and related to the AtriClip Device. Medication was administered. Resolved without sequelae.
Frequency: 1 affected / 376 at risk
Study: NCT02701101

Adverse event: Unrelated to device AE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk
Study: NCT02701257

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglycemia (may or may not include associated ketosis and vomiting) found to be associated with insulin infusion set failure
Frequency: 7 affected / 12 at risk
Study: NCT02701270

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk
Study: NCT02701413

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Urinary Tract Infection, unknown if related to device use
Frequency: 1 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain with device use
Frequency: 1 affected / 26 at risk