TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03759665

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The patient experienced a fracture of lumbar vertebrae due to a fall. The patient had recurrent falls in the medical history, as a symptom of Tay-Sachs disease and the investigator considered the event not related to study medication.
Frequency: 1 affected / 30 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The patient experienced a fracture of lumbar vertebrae due to a fall. The patient had recurrent falls in the medical history, as a symptom of Tay-Sachs disease and the investigator considered the event not related to study medication.
Frequency: 1 affected / 30 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: The patient suffered from concomitant bipolar disorder which deteriorated. The investigator judged the event not related to study medication.
Frequency: 1 affected / 30 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: The patient suffered from concomitant bipolar disorder which deteriorated. The investigator judged the event not related to study medication.
Frequency: 1 affected / 30 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 30 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 30 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 30 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk
Study: NCT03760016

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: recurrent stroke, judged to be unrelated to study procedures
Frequency: 1 affected / 27 at risk

Adverse event: Pain/soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain/soreness related to treatment
Frequency: 8 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue related to treatment
Frequency: 2 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: lightheadedness related to treatment
Frequency: 3 affected / 27 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: Fall without injury related to treatment
Frequency: 3 affected / 27 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: seizure leading to temporary hospitalization, judged to be unrelated to study procedures
Frequency: 1 affected / 28 at risk

Adverse event: fall with fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: fall with hip fracture, judged to be unrelated to study procedures
Frequency: 1 affected / 28 at risk

Adverse event: Delirium
Serious: yes
Organ System: Nervous system disorders
Notes: delirium leading to temporary hospitalization, judged to be unrelated to study procedures
Frequency: 1 affected / 28 at risk

Adverse event: Pain/soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain/soreness related to treatment
Frequency: 7 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue related to treatment
Frequency: 2 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: lightheadedness related to treatment
Frequency: 4 affected / 28 at risk
Study: NCT03760185

Adverse event: Surgery- Cryoablation of prostate
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 13 at risk

Adverse event: Kidney & Urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ophthalmology - Cataracts
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cardio - MI
Serious: no
Organ System: Cardiac disorders
Notes: Patient disclosed to study PI that he had an MI and was treated at an outside hospital with a stent surgery.
Frequency: 1 affected / 13 at risk

Adverse event: Surgery- Cryoablation of prostate
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 13 at risk

Adverse event: Kidney & Urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ophthalmology - Cataracts
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cardio - MI
Serious: no
Organ System: Cardiac disorders
Notes: Patient disclosed to study PI that he had an MI and was treated at an outside hospital with a stent surgery.
Frequency: 1 affected / 13 at risk
Study: NCT03760419

Adverse event: ED revisit within 72 hours
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient returns to the Emergency Department within 72 hours for same illness as index visit.
Frequency: 19 affected / 478 at risk

Adverse event: ED revisit within 7 days
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient returns to the Emergency Department within 7 days for same illness as index visit.
Frequency: 32 affected / 478 at risk

Adverse event: Re-hospitalization within 72 hours
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient is admitted to the hospital within 72 hours for same illness as index visit.
Frequency: 9 affected / 478 at risk

Adverse event: Re-hospitalization within 7 days
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient is admitted to the hospital within 7 days for same illness as index visit.
Frequency: 23 affected / 478 at risk

Adverse event: ED revisit within 72 hours
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient returns to the Emergency Department within 72 hours for same illness as index visit.
Frequency: 22 affected / 549 at risk

Adverse event: ED revisit within 7 days
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient returns to the Emergency Department within 7 days for same illness as index visit.
Frequency: 30 affected / 549 at risk

Adverse event: Re-hospitalization within 72 hours
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient is admitted to the hospital within 72 hours for same illness as index visit.
Frequency: 7 affected / 549 at risk

Adverse event: Re-hospitalization within 7 days
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient is admitted to the hospital within 7 days for same illness as index visit.
Frequency: 15 affected / 549 at risk
Study: NCT03760510

Adverse event: Self-Extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient self-extubation
Frequency: 2 affected / 145 at risk

Adverse event: Self-Extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient self-extubation
Frequency: 2 affected / 153 at risk
Study: NCT03760640

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 42 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk
Study: NCT03760718

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT03760796

Adverse event: Inpatient hospital readmission within 30 days post-discharge
Serious: yes
Organ System: General disorders
Notes: Number of participants that were readmitted within 30 days post-discharge among the 200 Corrie participants that completed the study.
Frequency: 13 affected / 200 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Notes: Report of bruising on participant forearm, where the Apple Watch was located. Bruising was reported in other locations. The participant was on blood thinners, with a history of bruising. It is uncertain if the Apple Watch contributed to bruising.
Frequency: 1 affected / 200 at risk
Study: NCT03761368

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: skin petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: petechiae on the skin of preconditioned arm distally to upper - arm cuff placement
Frequency: 1 affected / 50 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk
Study: NCT03761394

Adverse event: Chest Pain and hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: The patient was hospitalized for chest pain on 6/10/2021
Frequency: 1 affected / 90 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participants had skin irritation to the Cardiac Insight patch. They were asked to remove the Cardiac Insight patch and not place their second patch.
Frequency: 1 affected / 90 at risk

Adverse event: Myocardial infarction and hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: The patient had a myocardial infarction and was hospitalized for a period of time. This was completely unrelated to our study protocol/procedures. Once the patient was discharged, they withdrew and wanted to focus on recovering from the event.
Frequency: 1 affected / 30 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Notes: The participant was admitted to the hospital on 3/27/2020 with weakness and a nonproductive cough. He was diagnosed with a COVID-19 infection. He was then discharged on 3/28/2020 with instructions to self-quarantine
Frequency: 1 affected / 30 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Infections and infestations
Notes: The patient was hospitalized for pancreatitis
Frequency: 1 affected / 30 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participants had skin irritation to the Cardiac Insight patch. They were asked to remove the Cardiac Insight patch and not place their second patch.
Frequency: 3 affected / 30 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Infections and infestations
Notes: The patient was hospitalized for pancreatitis
Frequency: 1 affected / 57 at risk
Study: NCT03761615

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Severe hypoglycemia with possible seizures
Frequency: 2 affected / 25 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 25 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 25 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 25 at risk
Study: NCT03761784

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 274 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 17 affected / 274 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 274 at risk

Adverse event: Application site exfoliation
Serious: no
Organ System: General disorders
Frequency: 14 affected / 274 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 274 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 274 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 274 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 274 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 139 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Attention deficit hyperactivity disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 139 at risk
Study: NCT03761810

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 281 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 281 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 281 at risk

Adverse event: Application site exfoliation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 281 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 281 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 281 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 281 at risk

Adverse event: Application site photosensitivity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 281 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 281 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 281 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 138 at risk

Adverse event: Bipolar II disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 138 at risk

Adverse event: Behaviour disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 138 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Application site photosensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 138 at risk
Study: NCT03762213

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Moderate dizziness \>30 on a scale of 0-100
Frequency: 3 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Moderate nausea \>30 on a scale of 0-100
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Moderate headache \>30 on a scale of 0-100
Frequency: 4 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Moderate dizziness \>30 on a scale of 0-100
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Moderate nausea \>30 on a scale of 0-100
Frequency: 2 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Moderate headache \>30 on a scale of 0-100
Frequency: 2 affected / 14 at risk
Study: NCT03763175

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Metallic Taste, Paresthesia, Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal Pain, Bloating, Flatulence, Nausea, Indigestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Hemiplegic migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 19 at risk

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

Adverse event: Abdominal Pain, Bloating, Flatulence, Nausea, Indigestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Muscle Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Metallic Taste, Paresthesia, Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal Pain, Bloating, Flatulence, Nausea, Indigestion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk
Study: NCT03763331

Adverse event: Supraventricular tachycardia at the onset of treadmill test
Serious: no
Organ System: Cardiac disorders
Notes: Supraventricular tachycardia at the onset of treadmill test
Frequency: 1 affected / 18 at risk

Adverse event: Fall during the 6-min walk test
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fall during the 6-min walk test
Frequency: 1 affected / 18 at risk

Adverse event: Joint injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee injury
Frequency: 1 affected / 18 at risk

Adverse event: Transient mild leg skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient mild leg skin irritation
Frequency: 1 affected / 18 at risk
Study: NCT03763708

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Device stimulation issue
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 15 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 15 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Medical device site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk
Study: NCT03763747

Adverse event: Target Lesion Revascularization Clinically Indicated TLR)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Myocardial Infarction (Non Q-wave)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Myocardial Infarction (Non Q-wave)
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 200 at risk

Adverse event: Clinically Significant Arrhythmias (Requiring Intervention)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk