TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03665155

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Neutrophil 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: 2 affected / 7 at risk
Study: NCT03666858

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 216 at risk

Adverse event: Lack of vitamin D
Serious: no
Organ System: General disorders
Frequency: 1 affected / 216 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 216 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk
Study: NCT03667014

Adverse event: Facial erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Eyelid swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk
Study: NCT03667924

Adverse event: Cancer treatment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Other Adverse Event
Serious: no
Organ System: General disorders
Notes: insufficient documentation to categorize further
Frequency: 1 affected / 33 at risk

Adverse event: Fall/ED visit or hospitalization
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Transient global amnesia diagnosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk
Study: NCT03668236

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 755 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 755 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 755 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 755 at risk

Adverse event: Severe acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 173 affected / 750 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 776 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 776 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: General disorders
Frequency: 44 affected / 776 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 776 at risk

Adverse event: Severe acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 189 affected / 772 at risk
Study: NCT03668600

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 230 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 191 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 230 at risk
Study: NCT03668873

Adverse event: PICA event
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Eating of non-food items that resulted in emergency department visitation for observation.
Frequency: 1 affected / 32 at risk

Adverse event: cold or unknown virus
Serious: no
Organ System: Infections and infestations
Notes: cold or unknown virus
Frequency: 9 affected / 32 at risk

Adverse event: Tooth injury
Serious: no
Organ System: General disorders
Notes: Chipped tooth or lost tooth
Frequency: 2 affected / 32 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: COVID-19 Positive
Frequency: 1 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: PICA event
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Eating of non-food items that resulted in emergency department visitation for observation.
Frequency: 1 affected / 36 at risk

Adverse event: cold or unknown virus
Serious: no
Organ System: Infections and infestations
Notes: cold or unknown virus
Frequency: 11 affected / 36 at risk

Adverse event: Tooth injury
Serious: no
Organ System: General disorders
Notes: Chipped tooth or lost tooth
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk
Study: NCT03669042

Adverse event: Bleeding event
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 94 at risk

Adverse event: cardiac event
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 94 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 94 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: The events reported were in one PAD patient and one CAS patient; both were contralateral (not a primary endpoint).
Frequency: 2 affected / 94 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 94 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 94 at risk

Adverse event: Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 94 at risk

Adverse event: Symptomatic Carotid Occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 94 at risk

Adverse event: cardiac event
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 94 at risk

Adverse event: Bleeding event
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 94 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 94 at risk

Adverse event: Inflammation/Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 94 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 94 at risk
Study: NCT03669133

Adverse event: COVID
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Both participants, during the course of the study, contracted COVID.
Frequency: 1 affected / 1 at risk

Adverse event: COVID
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Both participants, during the course of the study, contracted COVID.
Frequency: 1 affected / 1 at risk
Study: NCT03669250

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Blood glucose abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Blood sodium abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk
Study: NCT03669861

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia is a condition in which you have a low blood platelet count. Platelets (thrombocytes) are colorless blood cells that help blood clot. Platelets stop bleeding by clumping and forming plugs in blood vessel injuries
Frequency: 1 affected / 10 at risk

Adverse event: Episcleritis
Serious: no
Organ System: Eye disorders
Notes: Episcleritis is inflammation of the tissue lying between the sclera (the tough, white, fiber layer covering the eye) and the conjunctiva (the membrane that lines the eyelid and covers the white of the eye).
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT03670004

Adverse event: Head injury
Serious: yes
Organ System: General disorders
Notes: Head injury experienced from a fall during 12-month prospective fall data collection
Frequency: 1 affected / 13 at risk
Study: NCT03670030

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

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

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

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 5 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Platelet count decrease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk
Study: NCT03670160

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Clonidine dose held - 2 infants developed hypotension requiring additional clonidine weaning to resolve.
Frequency: 2 affected / 14 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Clonidine dose held. 1 infant experienced rebound hypertension which resolved with no clonidine wean adjustment to resolve.
Frequency: 1 affected / 14 at risk
Study: NCT03670602

Adverse event: Torn Retina
Serious: yes
Organ System: Eye disorders
Notes: Torn retina due to age, per participant's MD. Underwent emergency surgery within four days of event occurrence, 1 month recovery period.
Frequency: 1 affected / 31 at risk
Study: NCT03670641

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: This is defined as events of continuous glucose monitor or self-monitored blood glucose measure \<70mg/dL that did not result in neuroglycopenia or require the assistance of others to resolve and was transient.
Frequency: 7 affected / 10 at risk

Adverse event: Signal Loss with Continuous Glucose Monitor (CGM)
Serious: no
Organ System: Endocrine disorders
Notes: This captures the number of participants who had signal loss with their CGM from greater than 4 hours
Frequency: 6 affected / 10 at risk
Study: NCT03670836

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Blood loss of more than 1000cc immediately after delivery
Frequency: 1 affected / 151 at risk

Adverse event: Uterine tachysystole
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Too frequent uterine contractions during labor induction
Frequency: 35 affected / 151 at risk

Adverse event: uterine tachy systole with abnormal fetal heart tracing
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 151 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Blood loss of more than 1000cc immediately after delivery
Frequency: 3 affected / 152 at risk

Adverse event: Uterine tachysystole
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Too frequent uterine contractions during labor induction
Frequency: 70 affected / 152 at risk

Adverse event: uterine tachy systole with abnormal fetal heart tracing
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 152 at risk
Study: NCT03672032

Adverse event: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 67 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 67 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cholangitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 67 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Small hepatic hematoma. No intervention required. Patient was discharged after 1 day.
Frequency: 1 affected / 67 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 67 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 67 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 67 at risk
Study: NCT03672370

Adverse event: Infection, revision required
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Periprosthetic fractures, revision required
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 89 at risk

Adverse event: Lung cancer, unknown treatment
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Traumatic event at outpatient rehab, surgical fragment fixation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Death, unknown reason, no relation to device
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 89 at risk

Adverse event: femoral implant loosening
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A patient mentioned a femoral implant loosening at the phone, which was treated in another hospital, however was not able to provide any further details. The patient asked for discontinuation of the study.
Frequency: 1 affected / 89 at risk

Adverse event: Pain in hip when sitting down, radiating to the knee
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported slight pain when sitting down, radiating to the knee. The pain is tolerated and no further treatment is required at the moment. No further information to this case were available.
Frequency: 1 affected / 89 at risk
Study: NCT03672396

Adverse event: calcium pyrophosphate deposition disease
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk
Study: NCT03672643

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

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

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

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

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

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypoproteinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 41 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Biochemical pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 41 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk