TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00589420

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: diarreha
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk

Adverse event: hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 17 at risk

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

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 17 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 17 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 17 at risk
Study: NCT00589472

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 19 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 19 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Cardiac disorders-Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 19 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 19 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 19 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT00589628

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization for a positive blood culture, but repeat negative and felt to be consistent with a contaminated culture. Subject also had myalgias and ear cellulitis. Refused further follow up
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk
Study: NCT00589888

Adverse event: venous irritation
Serious: no
Organ System: Vascular disorders
Notes: temporary irritation of vein towards the end of the 8-hour infusion; no permanent sequelae or discontinuation
Frequency: 1 affected / 13 at risk

Adverse event: venous irritation
Serious: no
Organ System: Vascular disorders
Notes: temporary irritation of vein towards the end of the 8-hour infusion; no permanent sequelae or discontinuation
Frequency: 1 affected / 13 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: temporary symptoms of reflux after ingesting the meal; no permanent sequelae or discontinuation
Frequency: 1 affected / 13 at risk
Study: NCT00590018

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death likely underlying heart disease - worsening function \& arrhythmias. Study drug 9/20/04-9/24/04. No infections or bleeding. Weaned from inotropes after study drug. Deteriorated subsequently. Cleared by data safety monitoring board.
Frequency: 1 affected / 9 at risk
Study: NCT00590044

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Severe hypoglycemia is defined as blood glucose level \< 40 mg/dL that required immediate invasive intervention
Frequency: 1 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycemia is defined as blood glucose level \<70 mg/dL
Frequency: 5 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Severe hypoglycemia is defined as blood glucose level \< 40 mg/dL that required immediate invasive intervention
Frequency: 2 affected / 36 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycemia is defined as blood glucose level \<70 mg/dL
Frequency: 14 affected / 36 at risk
Study: NCT00590122

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk
Study: NCT00590161

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 26 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk
Study: NCT00590226

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 67 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 63 at risk
Study: NCT00590317

Adverse event: Akathisia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Akathisia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk
Study: NCT00590460

Adverse event: CNC hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 5 at risk

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

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

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 5 at risk

Adverse event: Picorna virus sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk
Study: NCT00590564

Adverse event: Conduction abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cellulitis (skin)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Aspartate Aminotransferase (AST)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 24 at risk

Adverse event: Alanine Aminotransferase (ALT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 24 at risk
Study: NCT00590720

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Traumatic pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4 at risk

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

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

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

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

Adverse event: Magnetic resonance imaging abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Blood bicarbonate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT00590759

Adverse event: Bleeding Complication
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 52 affected / 150 at risk

Adverse event: Cardiac Complication
Serious: no
Organ System: Cardiac disorders
Frequency: 64 affected / 150 at risk

Adverse event: Bowel Complication
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 150 at risk

Adverse event: Additional Implantation
Serious: no
Organ System: General disorders
Frequency: 16 affected / 150 at risk

Adverse event: Other Complication
Serious: no
Organ System: General disorders
Frequency: 102 affected / 150 at risk

Adverse event: Stent-graft endoleak
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 58 affected / 150 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 43 affected / 150 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 150 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 150 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 150 at risk

Adverse event: Renal Function Complication
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 150 at risk

Adverse event: Pulmonary Complication
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 150 at risk

Adverse event: Vascular Complication
Serious: no
Organ System: Vascular disorders
Frequency: 56 affected / 150 at risk
Study: NCT00590889

Adverse event: Explant due to PV (para-valvular) leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 404 at risk

Adverse event: All reported explants
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 404 at risk

Adverse event: All reported explants/repairs
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 404 at risk

Adverse event: Major PV (Para-Valvular) leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 404 at risk

Adverse event: Stroke/RIND
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 404 at risk

Adverse event: All Cause Mortality
Serious: yes
Organ System: Cardiac disorders
Frequency: 130 affected / 404 at risk

Adverse event: Confirmed TE
Serious: no
Organ System: Cardiac disorders
Frequency: 61 affected / 404 at risk

Adverse event: Confirmed TE without TIA
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 404 at risk

Adverse event: Confimred TE Stroke
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 404 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 404 at risk

Adverse event: Explant due to PV (para-valvular) leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 403 at risk

Adverse event: All reported explants
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 403 at risk

Adverse event: All reported explants/repairs
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 403 at risk

Adverse event: Major PV (Para-Valvular) leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 403 at risk

Adverse event: Stroke/RIND
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 403 at risk

Adverse event: All Cause Mortality
Serious: yes
Organ System: Cardiac disorders
Frequency: 140 affected / 403 at risk

Adverse event: Confirmed TE
Serious: no
Organ System: Cardiac disorders
Frequency: 59 affected / 403 at risk

Adverse event: Confirmed TE without TIA
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 403 at risk

Adverse event: Confimred TE Stroke
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 403 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 403 at risk
Study: NCT00591006

Adverse event: Pre-existing condition discovered during MRI
Serious: yes
Organ System: Nervous system disorders
Notes: Mega cisterna magna discovered at initial MRI. Determined to be benign.
Frequency: 1 affected / 16 at risk

Adverse event: MRI anxiety
Serious: yes
Organ System: General disorders
Notes: Physical symptoms manifesting from stress of MRI scan during scan (e.g. difficulty breathing, sweating, tremors, disorientation, etc.)
Frequency: 1 affected / 14 at risk
Study: NCT00591253

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 137 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 137 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 137 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 137 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 137 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 137 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 138 at risk
Study: NCT00591266

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 190 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 190 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 188 at risk

Adverse event: Ovarian cyst torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 188 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 188 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 185 at risk
Study: NCT00591318

Adverse event: Prolongation of hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Individual's psychosis symptoms worsened
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash on skin that resolved
Frequency: 3 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea not due to C.Difficile
Frequency: 2 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain at site of IV catheter
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash on skin that resolved
Frequency: 1 affected / 5 at risk
Study: NCT00591344

Adverse event: DBS surgery
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization for bowel obstruction
Frequency: 1 affected / 25 at risk

Adverse event: Elbow pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Occurred after fall at home and required medical intervention
Frequency: 1 affected / 25 at risk

Adverse event: Bilateral hip replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: unilateral knee replacement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pt had both knees replaced during separate surgeries
Frequency: 1 affected / 25 at risk

Adverse event: Knee surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee surgery to remove old debris
Frequency: 1 affected / 25 at risk

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Long term hospitalization after fall at home
Frequency: 1 affected / 25 at risk

Adverse event: Foot operation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Passed away
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Passed away after getting hit by a car
Frequency: 1 affected / 26 at risk

Adverse event: DBS surgery
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Amyotrophic lateral sclerosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Developed ALS during the study
Frequency: 1 affected / 26 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 26 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back surgery for stenosis
Frequency: 1 affected / 26 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Wrist pain while during MVC during testing
Frequency: 1 affected / 26 at risk