TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02375724

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 135 at risk

Adverse event: Cartilage injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 135 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 135 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 135 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 134 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 134 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 134 at risk
Study: NCT02375984

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

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: secondary to PICC line placement and treatment
Frequency: 1 affected / 1 at risk

Adverse event: Other, sunburn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT02376010

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 51 at risk
Study: NCT02376166

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Dehydration from anorexia and nausea requiring hospitalization. Resolved with discontinuation of metformin and intravenous hydration
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Consitipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 15 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 15 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Queasiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT02376257

Adverse event: Increased Energy/Concentration
Serious: no
Organ System: General disorders
Notes: Mild levels of symptoms reported with no distress
Frequency: 2 affected / 13 at risk

Adverse event: Fatigue/Low Motivation
Serious: no
Organ System: General disorders
Notes: Mild levels of symptoms were reported with no distress
Frequency: 2 affected / 13 at risk

Adverse event: Increased Energy/Concentration
Serious: no
Organ System: General disorders
Notes: Mild levels of symptoms reported with no distress
Frequency: 4 affected / 12 at risk

Adverse event: Fatigue/Low Motivation
Serious: no
Organ System: General disorders
Notes: Mild levels of symptoms were reported with no distress
Frequency: 3 affected / 12 at risk

Adverse event: Increased Energy/Concentration
Serious: no
Organ System: General disorders
Notes: Mild levels of symptoms reported with no distress
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue/Low Motivation
Serious: no
Organ System: General disorders
Notes: Mild levels of symptoms were reported with no distress
Frequency: 5 affected / 11 at risk
Study: NCT02376933

Adverse event: Gastrointestinal - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 10 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk
Study: NCT02377089

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment emergent headaches described as mild to moderate were reported by one participant. Subject discontinued participation due to this event. Headaches did not persist after discontinuation of use. This is an anticipated adverse event.
Frequency: 1 affected / 29 at risk
Study: NCT02377674

Adverse event: Left Lower Lobe Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Pleural Effusion Caused by Cardiac Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Cardiac Failure, poly seriositis NYHA III
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Stenosis of Conduit
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 5 at risk

Adverse event: Decreased LVEF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Bundle Branch Block Onset
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Low Stroke Volume in the IVC and Conduit
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Mild Stenosis In Conduit
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Reduced Maximum Systolic Velocity
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk
Study: NCT02377700

Adverse event: Stenosis in the bi-directional cava pulmonary anastomosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sick sinus syndrome and bundle branch block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Supraventricular tachycardia and atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk
Study: NCT02377947

Adverse event: Diarrhea and Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Only ADRs and complications were collected. Observed non serious ADRs are either considered to be sufficiently described in the section on undesirable effects in local label and/or associated with the method of administration as a retention enema
Frequency: 1 affected / 50 at risk

Adverse event: Abdominal fullness and discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Only ADRs and complications were collected. Observed non serious ADRs are either considered to be sufficiently described in the section on undesirable effects in local label and/or associated with the method of administration as a retention enema
Frequency: 1 affected / 50 at risk

Adverse event: Mild rectal bleed
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Only ADRs and complications were collected. Observed non serious ADRs are either considered to be sufficiently described in the section on undesirable effects in local label and/or associated with the method of administration as a retention enema
Frequency: 1 affected / 50 at risk
Study: NCT02378181

Adverse event: Hospitalization for Suicidal Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk
Study: NCT02378298

Adverse event: Mental disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Inpatient care due to mental disorder
Frequency: 1 affected / 10 at risk

Adverse event: Cerebral aneurysm
Serious: yes
Organ System: Nervous system disorders
Notes: Inpatient care when cerebral aneurysm was diagnosed and new event of inpatient care for operation of aneurysm in the same individual
Frequency: 1 affected / 10 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Notes: Systolic blood pressure \> 140 or diastolic blood pressure \> 90
Frequency: 5 affected / 10 at risk

Adverse event: Positive oral glucose tolerance test
Serious: no
Organ System: Endocrine disorders
Notes: Diabetes or glucose intolerance
Frequency: 3 affected / 10 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Notes: Systolic blood pressure \> 140 or diastolic blood pressure \> 90
Frequency: 7 affected / 13 at risk

Adverse event: High liver tests
Serious: no
Organ System: Hepatobiliary disorders
Notes: 3-fold elevation of AST or ALT
Frequency: 1 affected / 13 at risk

Adverse event: Positive oral glucose tolerance test
Serious: no
Organ System: Endocrine disorders
Notes: Diabetes or glucose intolerance
Frequency: 2 affected / 13 at risk

Adverse event: Inadequate response to short ACTH
Serious: no
Organ System: Endocrine disorders
Notes: A short ACTH test was conducted by measuring serum cortisol at 0, 30, and 60 min after IV ACTH 250 µg
Frequency: 1 affected / 13 at risk
Study: NCT02378662

Adverse event: Intermittent Muscle cramps in both legs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Catheter exit site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Allergic reaction to ciprofloxacin
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Swelling in right groin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Redness in right groin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk
Study: NCT02379221

Adverse event: Syncopal Episode
Serious: no
Organ System: Vascular disorders
Notes: Participant had just received his HA filler treatment when he had a syncopal episode. He was still sitting in chair it lasted approximately 30 seconds. He was treated per OMFS department protocol. He was fully recovered before he left the clinic.
Frequency: 1 affected / 49 at risk
Study: NCT02379273

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Subject reported to have had a heart attack prior to the 5-year postactivation evaluation. Subject was hospitalized to have stents placed, hence the adverse event (AE) was deemed serious. This AE was unrelated to the study device.
Frequency: 1 affected / 35 at risk

Adverse event: Cochlear implant revision
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Subject experienced a change in hearing and elected to have the Hybrid L replaced with a traditional cochlear implant 8 years after receiving the Hybrid implant.
Frequency: 1 affected / 35 at risk

Adverse event: Cochlear implant revision
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Subject had revision surgery to replace a contralateral Hybrid L implant, placed after Hybrid approval, associated with loss of residual hearing. Not related to the study device or procedure since it involved the non-study ear.
Frequency: 1 affected / 35 at risk

Adverse event: Teeth cracking and pain associated with Bruxism
Serious: no
Organ System: General disorders
Notes: At study baseline, subject reported teeth cracking associated with pre-existing condition, bruxism (clenching of the teeth/jaw during sleep). Related to a pre-existing condition and not procedure/device related.
Frequency: 1 affected / 35 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Subject reported soreness under the external processor coil during a routine follow-up visit. Resolved with lower magnet setting.
Frequency: 1 affected / 35 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: After 6 years of device use, subject reported new low-frequency pulsatile tinnitus that occurred intermittently for a few hours daily in the implanted ear. Not device or procedure related as tinnitus present without device use.
Frequency: 1 affected / 35 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: During final study visit, subject reported a sore and pain on top of pinna. Resolved with use of moleskin on ear hook.
Frequency: 1 affected / 35 at risk

Adverse event: Perceived change in hearing due to wax occlusion
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Wax occlusion resulting perceived decreased hearing in right (contralateral) ear, and feeling of water in ear. Resolved following removal of wax. Not related to study ear.
Frequency: 1 affected / 35 at risk
Study: NCT02379637

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk
Study: NCT02379819

Adverse event: Explantation at patient's request due to sound quality
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 52 at risk

Adverse event: Profound hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 20 affected / 52 at risk

Adverse event: New or worsened tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 52 at risk

Adverse event: Vertigo/dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 52 at risk

Adverse event: Skin irritation due to externals
Serious: no
Organ System: General disorders
Frequency: 5 affected / 52 at risk

Adverse event: Pain in implanted ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 52 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Sound quality issue
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 52 at risk

Adverse event: Taste/Tongue disturbance
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Small parts hazard
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 52 at risk
Study: NCT02380287

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Elevated AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk
Study: NCT02380703

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: No information on cause of death
Frequency: 2 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: No information on cause of death
Frequency: 5 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk
Study: NCT02380859

Adverse event: Freezing
Serious: no
Organ System: Nervous system disorders
Notes: Foot Froze and balance was affected
Frequency: 1 affected / 17 at risk

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

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