TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04239924

Adverse event: Serious Adverse Events
Serious: yes
Organ System: Vascular disorders
Notes: Pt presented w/ stroke symptoms of LE weakness. MRI showed acute right thalamic infarct \& vascular imaging showed no flow limiting stenosis of carotids. Pt given aspirin, statin, antihypertensives. Pt d/c to f/u w/ stroke clinic, \& rec'd home health
Frequency: 1 affected / 20 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Vascular disorders
Notes: Pt presented to ED c/o 2 weeks worsening chest pain w/ SOB. Pt HTN in ED. CXR, Trops and ECG WNL. CT shows no PE. After admission pt able to complete walking desaturation test, HTN decreased. Pt d/c w/ instructions to f/u w/ PCP.
Frequency: 1 affected / 20 at risk

Adverse event: Serious Adverse Event
Serious: yes
Organ System: General disorders
Notes: Pt presented to ED c/o worsening LE weakness. Pt admitted after elevated trop-NSTEMI type 2 demand. Cardiology placed pt on heparin infusion for 48 hrs. Pt stable, LLL pneumonia resolved with IV abx. D/c to SNF for PT/OT therapy \& f/u w/ PCP \& Cardio
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Renal and urinary disorders
Notes: 3 visits to ED for Urinary Catheter Problem within 1 week
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Vascular disorders
Notes: Pt presented to ED with Dizziness
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Nervous system disorders
Notes: Pt presented to ED with Altered Mental Status
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Vascular disorders
Notes: Pt presented to ED with Hypertension
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Vascular disorders
Notes: Pt presented to ED with Chest Pain
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pt presented to ED with Abdominal Pain twice in one week
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Pt presented to ED with Fall
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: Vascular disorders
Notes: Pt presented to ED with Weakness
Frequency: 1 affected / 20 at risk

Adverse event: ED Use
Serious: no
Organ System: General disorders
Notes: Pt presented to ED with Leg Problem
Frequency: 1 affected / 20 at risk
Study: NCT04240457

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: Subject complained of increased photophobia at the 1 week post-procedure visit. Noted resolved at the 1 mo. visit
Frequency: 1 affected / 7 at risk
Study: NCT04242173

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

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk
Study: NCT04242186

Adverse event: Intraventricular hemorrhage following a fall and resulting in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Advanced dementia resulting in death
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Suspected cardiac event resulting in death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Urosepsis resulting in hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Agitation and aggression resulting in hospitalization
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Acute colitis resulting in hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Adverse drug withdrawal event
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk
Study: NCT04243070

Adverse event: Cardiac procedure complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 66 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

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

Adverse event: Bone marrow infiltration
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Endometrial disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 23 at risk

Adverse event: Puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk
Study: NCT04243096

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Spinal Tumor
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 60 at risk
Study: NCT04243512

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk
Study: NCT04243837

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 28 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk
Study: NCT04244084

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 118 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

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

Adverse event: Acute tubootitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Intercostal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Community-acquired pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

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

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Increase in the percentage of basophils
Serious: no
Organ System: Investigations
Frequency: 1 affected / 118 at risk

Adverse event: Increase in the percentage of eosinophils
Serious: no
Organ System: Investigations
Frequency: 1 affected / 118 at risk

Adverse event: Exacerbation of bronchial asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Edema of the lips and face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Worsening of the disease
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk
Study: NCT04244253

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 121 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 121 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 121 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 121 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 121 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 121 at risk
Study: NCT04244370

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Colorectal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk
Study: NCT04244396

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 81 at risk

Adverse event: Bleeding/Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 81 at risk

Adverse event: Cerebrovascular Accident/ Stroke
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 81 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Chest Pain/Discomfort
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: Elective Procedure/Surgery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Heart Failure/Pump Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 81 at risk

Adverse event: Acute Gout
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Common Bile Duct Stone With Cholangitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Finger Fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Unexplained Jaundice And Raised Liver Panel
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: Vascular Bleeding/Local Hematomas/Ecchymosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 81 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk
Study: NCT04245111

Adverse event: Complication due to surgery
Serious: yes
Organ System: General disorders
Notes: complication from surgery post surgical procedure. Unrelated to study/expected.
Frequency: 2 affected / 13 at risk

Adverse event: Rehospitalization for procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Rehospitalization for additional planned procedure. Unrelated to study/expected.
Frequency: 1 affected / 6 at risk

Adverse event: Complication due to surgery
Serious: yes
Organ System: General disorders
Notes: complication from surgery post surgical procedure. Unrelated to study/expected.
Frequency: 1 affected / 6 at risk
Study: NCT04245202

Adverse event: Transient bradicardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 39 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Transient bradicardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk
Study: NCT04245501

Adverse event: COVID, cold, flu, other illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: COVID, cold, flu, other illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk
Study: NCT04246021

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Notes: hypophosphatemia
Frequency: 17 affected / 26 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Notes: hypophosphatemia
Frequency: 6 affected / 24 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Notes: hypophosphatemia
Frequency: 16 affected / 34 at risk
Study: NCT04246554

Adverse event: nausea/ vomitin
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 26 at risk

Adverse event: drowsy
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: nausea/ vomitin
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: drowsy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk
Study: NCT04246801

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 140 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 140 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 71 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 71 at risk

Adverse event: Photophobia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 71 at risk
Study: NCT04246996

Adverse event: Reoperation for hematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 183 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Uncontrolled postoperative pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 183 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Admitted for planned breast surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 183 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 180 at risk

Adverse event: Reoperation for sling division
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk
Study: NCT04247074

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 123 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 123 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 123 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 58 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 58 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 116 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 116 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 116 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 116 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 3 affected / 116 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 115 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 115 at risk
Study: NCT04247100

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject used TENS device for the first time 4/8/21 and woke up 4/9/21 with nausea, stomach pain, diarrhea and hiccups. Symptoms did not improve after 5 days, so subject was withdrawn at PI discretion and referred for GI follow-up. Unrelated to TENS.
Frequency: 1 affected / 5 at risk