TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03179995

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Bilateral leg swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: QT prolongation
Serious: no
Organ System: Investigations
Frequency: 6 affected / 11 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: QT prolongation
Serious: no
Organ System: Investigations
Frequency: 5 affected / 12 at risk

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

Adverse event: septic shock due to infected biloma
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk
Study: NCT03180008

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant fell on ice, due to winter weather, outside of study site for follow-up visit. No serious or lasting injuries reported.
Frequency: 1 affected / 210 at risk

Adverse event: Feeling faint/lightheaded
Serious: no
Organ System: General disorders
Notes: Feeling faint/lightheaded while exercising, not resulting in injury or other problems.
Frequency: 1 affected / 210 at risk

Adverse event: Feeling faint/lightheaded
Serious: no
Organ System: General disorders
Notes: Feeling faint/lightheaded while exercising, not resulting in injury or other problems.
Frequency: 1 affected / 203 at risk

Adverse event: Discomfort during exercise
Serious: no
Organ System: General disorders
Notes: Reports of feeling pain/discomfort during or resulting from exercise, without serious injury or other problems
Frequency: 3 affected / 203 at risk
Study: NCT03180385

Adverse event: Re-intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient had desaturation episode to 29% and was subsequently re-intubated on post-operative day #2.
Frequency: 1 affected / 2 at risk
Study: NCT03180489

Adverse event: Allergies
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 33 at risk

Adverse event: Stomach Pain and Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 33 at risk

Adverse event: Headache and Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 33 at risk

Adverse event: Muscle Joint Soreness and Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 33 at risk

Adverse event: Urinary Disorders, Yeast Infections and PMS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 33 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Oral herpes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Allergies
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 29 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 29 at risk

Adverse event: Stomach Pain and Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Headache and Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 29 at risk

Adverse event: Muscle Joint Soreness and Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 29 at risk

Adverse event: Urinary Disorders, Yeast Infections and PMS
Serious: no
Organ System: General disorders
Frequency: 7 affected / 29 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk
Study: NCT03180528

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 29 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, tumor hemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk
Study: NCT03180957

Adverse event: Adverse Events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Itching
Frequency: 6 affected / 70 at risk

Adverse event: Adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness
Frequency: 3 affected / 70 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Adverse Events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local Itching
Frequency: 4 affected / 70 at risk

Adverse event: Adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness
Frequency: 5 affected / 70 at risk
Study: NCT03181009

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea or vomiting
Frequency: 14 affected / 30 at risk

Adverse event: chills, facial edema, fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: cough, sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: pruritus, rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea or vomiting
Frequency: 12 affected / 30 at risk

Adverse event: chills, facial edema, fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 30 at risk

Adverse event: cough, sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: pruritus, rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk
Study: NCT03181529

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 24 at risk

Adverse event: Physical discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Mild controllable muscle motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Visual distortion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Blood pressure event
Serious: no
Organ System: Vascular disorders
Notes: A blood pressure event was defined by systolic blood pressure (SBP) \> 170 mmHG or diastolic blood pressure (DBP) \> 100 mmHg. In these instances, assessments were repeated every 5 minutes until criteria were no longer exceeded.
Frequency: 1 affected / 24 at risk

Adverse event: Heart rate event
Serious: no
Organ System: Cardiac disorders
Notes: A heart rate event was defined by heart rate (HR) \> 110 beats per minute. In these instances, assessments were repeated every 5 minutes until criteria were no longer exceeded.
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 24 at risk

Adverse event: Visual distortion
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk

Adverse event: Tenseness/soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Altered body sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Heart rate event
Serious: no
Organ System: Cardiac disorders
Notes: A heart rate event was defined by heart rate (HR) \> 110 beats per minute. In these instances, assessments were repeated every 5 minutes until criteria were no longer exceeded.
Frequency: 2 affected / 24 at risk
Study: NCT03181594

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Notes: HIV-positive patient developed an infection after stepping on a piece of glass at 23 days post treatment. Not related to the study device or procedure.
Frequency: 1 affected / 100 at risk

Adverse event: Colectomy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient with history of colon cancer had a partial colectomy at 250 days post treatment. Not related to the study device or procedure.
Frequency: 1 affected / 100 at risk

Adverse event: Sacroiliac joint dysfunction
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient underwent surgeries to treat pre-existing bilateral sacroiliac joint dysfunction at 64 and 113 days post treatment. Not related to the study device or procedure.
Frequency: 1 affected / 100 at risk

Adverse event: Retained pledget/epistaxis
Serious: yes
Organ System: Surgical and medical procedures
Notes: A retained pledget was removed from the patient's nose 19 days post treatment and resulted in profuse epistaxis. The event was related to the study procedure.
Frequency: 1 affected / 100 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial infarction with stent placement at 359 days post procedure. Not related to study device or procedure.
Frequency: 1 affected / 100 at risk

Adverse event: Carotid stenosis
Serious: yes
Organ System: Vascular disorders
Notes: Carotid stenosis treated with surgery at 711 days post procedure. Not related to the study device or procedure.
Frequency: 1 affected / 100 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Participants with various cancers (breast, gastric, liver, and brain) died during the study. None of the deaths were related to the study device or procedure.
Frequency: 4 affected / 100 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Participant underwent pacemaker placement at 592 days post procedure. Not related to the study device or procedure.
Frequency: 1 affected / 100 at risk

Adverse event: Nasal obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant underwent surgical procedures for nasal obstruction at 519 and 682 days post procedure. Not related to the study device or procedure.
Frequency: 1 affected / 100 at risk
Study: NCT03181828

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

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk
Study: NCT03181958

Adverse event: Nasal skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 137 affected / 480 at risk

Adverse event: Nasal skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 126 affected / 480 at risk

Adverse event: Nasal skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 119 affected / 480 at risk
Study: NCT03181971

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Cause of death not disclosed to research team due to privacy concern
Frequency: 1 affected / 680 at risk
Study: NCT03182686

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 144 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 144 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 144 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 144 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 144 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 144 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 144 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 144 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 144 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 144 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 144 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 144 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 144 at risk

Adverse event: Influenza-like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Injection site joint pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 24 at risk
Study: NCT03182751

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 64 at risk

Adverse event: Pulmonary Embolism (PE)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 64 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 64 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 64 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 64 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 64 at risk
Study: NCT03182920

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Sensation of foreign body
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 17 at risk
Study: NCT03182933

Adverse event: Falls
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fall as a result of prolonged quadriceps weakness
Frequency: 1 affected / 31 at risk
Study: NCT03183518

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk
Study: NCT03183869

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Difficulty Swallowing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 7 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk
Study: NCT03183908

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 378 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 378 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Stressed induced cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 378 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 378 at risk

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Near syncope due to orthostatic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 378 at risk

Adverse event: Pulmonary emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cold symptoms
Frequency: 15 affected / 378 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 379 at risk

Adverse event: Metastatic squamous cell
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 379 at risk

Adverse event: Post-operative ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 379 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 379 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cold symptoms
Frequency: 19 affected / 379 at risk
Study: NCT03185481

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Orthostatic hypotention
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 5 at risk
Study: NCT03185949

Adverse event: Chronic high-grade atherosclerotic stenosis of the external iliac artery
Serious: yes
Organ System: Vascular disorders
Notes: Patient with previously unrecognized chronic high-grade atherosclerotic stenosis of the external iliac artery underwent surgical correction. The SAE was determined to not be related to the device or procedure by the site investigator.
Frequency: 1 affected / 34 at risk

Adverse event: Asymptomatic Ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 34 at risk