TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01831817

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk
Study: NCT01831895

Adverse event: Hypotension - acute
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain - puncture site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Abnormal lab finding - hypokalemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Access site complication - hemorrhage - groin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Access site complications - postprocedural
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Anesthesia complications - blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Digestive system disorder - nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Digestive system disorder - vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Hypertension - acute
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain - head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Respiratory Abnormalities - Upper Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk
Study: NCT01831921

Adverse event: death from non-study related causes (colon cancer)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Participant was diagnosed with late-stage colon cancer during study and died as a result of cancer progression. This event was reviewed by the study safety officer and deemed unrelated to participation.
Frequency: 1 affected / 150 at risk

Adverse event: death from non-study related causes (aneurysm)
Serious: yes
Organ System: Vascular disorders
Notes: Participant suffered a ruptured aneurysm while driving and died. This event was reviewed by the study safety officer and deemed unrelated to participation.
Frequency: 1 affected / 150 at risk

Adverse event: Inpatient hospitalization for surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: 3 participants were hospitalized overnight for medical procedures unrelated to study participation.
Frequency: 2 affected / 150 at risk

Adverse event: Joint/Musculoskeletal Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain, injury, or discomfort in knee, shoulder, or other joints.
Frequency: 13 affected / 150 at risk

Adverse event: Inpatient hospitalization for surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: 3 participants were hospitalized overnight for medical procedures unrelated to study participation.
Frequency: 1 affected / 75 at risk

Adverse event: Joint/Musculoskeletal Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain, injury, or discomfort in knee, shoulder, or other joints.
Frequency: 10 affected / 75 at risk
Study: NCT01831934

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: A volunteer experienced 3 seizures lasting approximately 10 minutes. These were of the same type as his baseline seizures, but different in length and frequency. He was seen by his regular neurologist who left his medications unchanged.
Frequency: 1 affected / 12 at risk

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

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: report of occasional intermittent spasm of right jaw four days post vaccination
Frequency: 1 affected / 12 at risk
Study: NCT01831960

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: ACTH stimulation test abnormal
Serious: no
Organ System: Investigations
Notes: Adrenocorticotropic Hormone (ACTH) stimulation testing is conducted by the Cosyntropin Stimulation Test.
Frequency: 1 affected / 20 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: ACTH stimulation test abnormal
Serious: no
Organ System: Investigations
Notes: Adrenocorticotropic Hormone (ACTH) stimulation testing is conducted by the Cosyntropin Stimulation Test.
Frequency: 2 affected / 22 at risk
Study: NCT01832090

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 113 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 113 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 113 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 113 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 113 at risk

Adverse event: Nodule, Bumps/Lumps
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 113 at risk

Adverse event: Other, not within pre-defined (expected) AE categories
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 113 at risk
Study: NCT01832402

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

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal 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: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Stuffy Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 12 at risk

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

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 12 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01832493

Adverse event: Device stimulation issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Notes: Allergic reaction to antibiotic
Frequency: 1 affected / 50 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk
Study: NCT01832610

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 84 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 84 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 29 affected / 84 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 84 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 84 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Neurological Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 84 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 84 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 84 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 84 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 84 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 84 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 84 at risk

Adverse event: Other Intermacs
Serious: yes
Organ System: General disorders
Frequency: 48 affected / 84 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 84 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 84 at risk
Study: NCT01832753

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: unlikely related
Frequency: 1 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: Chapped lips, dry mouth, unlikely related to study
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: unlikely related
Frequency: 2 affected / 4 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash on back, unlikely related to study, resolved without intervention
Frequency: 1 affected / 4 at risk

Adverse event: Anxiety Symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: hair pulling \& difficulty urinating, unlikely related to study
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: unlikely related
Frequency: 1 affected / 5 at risk

Adverse event: Racing Heart
Serious: no
Organ System: Cardiac disorders
Notes: Racing Heart, Light Headedness, possibly related
Frequency: 1 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: not sleeping through the night, restless, irritable, unlikely related to study
Frequency: 1 affected / 5 at risk

Adverse event: Tired
Serious: no
Organ System: General disorders
Notes: possibly related to study, followed up with TSH/T4 check
Frequency: 1 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: not sleeping through the night, restless, irritable, unlikely related to study
Frequency: 1 affected / 6 at risk
Study: NCT01832818

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Notes: 1 patient developed a neurological impairment, this was not considered related to the surgery or the device.
Frequency: 1 affected / 14 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ongoing Dysphagia (mainly to solids), hoarse voice ( improving)
Frequency: 1 affected / 14 at risk

Adverse event: Pain in L forearm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Hyperaesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hyperesthesia C5/6 distribution L arm
Frequency: 1 affected / 14 at risk

Adverse event: Limited shoulder movement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Limited movement L shoulder
Frequency: 1 affected / 14 at risk
Study: NCT01833078

Adverse event: tired
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

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

Adverse event: mild and transient abdominal discomfort, rumbling and flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: mild and transient headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: transient feeling of pronounced heartbeat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Mild fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: feeling of laziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk
Study: NCT01833130

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Facial paresis
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT01833741

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1137 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1137 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1137 at risk
Study: NCT01833806

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: While in post-procedure recovery the subject became hypotensive with a systolic pressure in the 70s. He was feeling well later that day. The even resolved within 3 days.
Frequency: 1 affected / 32 at risk

Adverse event: Sonication Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 32 at risk

Adverse event: Skin burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Skin peeled
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Sore lip
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk
Study: NCT01833832

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 11 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 11 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk
Study: NCT01833845

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Asthenia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

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

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk
Study: NCT01833897

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: mild
Frequency: 2 affected / 8 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: mild
Frequency: 3 affected / 8 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypomania
Serious: no
Organ System: Psychiatric disorders
Notes: after stopping clinical medications
Frequency: 1 affected / 8 at risk