TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03349723

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk
Study: NCT03349775

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

Adverse event: GI upset (e.g. nausea, diarrhea, vomiting, abdominal discomfort, flatulence)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 10 at risk

Adverse event: Itching and rash/hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Left arm numbness and chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: GI upset (e.g. nausea, diarrhea, vomiting, abdominal discomfort, flatulence)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 11 at risk

Adverse event: Fatigue/Weakness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Itching and rash/hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Muscle or joint soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

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

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

Adverse event: Non-Specific Symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk
Study: NCT03350217

Adverse event: Intraprocedural Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Bleeding that occurred during the colonoscopy
Frequency: 14 affected / 77 at risk

Adverse event: Delayed Bleed
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Bleeding that occurred after the colonoscopy procedure
Frequency: 1 affected / 77 at risk

Adverse event: Type 3 Deep Mural Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 77 at risk

Adverse event: Intraprocedural Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Bleeding that occurred during the colonoscopy
Frequency: 13 affected / 81 at risk

Adverse event: Delayed Bleed
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Bleeding that occurred after the colonoscopy procedure
Frequency: 1 affected / 81 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 81 at risk
Study: NCT03350256

Adverse event: Subject fractured <1 vertebrae (compression) and was hospitalized overnight
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Hospitalization for abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Trial lead migration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 60 at risk
Study: NCT03350503

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 121 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 121 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 121 at risk

Adverse event: Haemmorhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 121 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Bile duct cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 121 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 121 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 121 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 121 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 121 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 121 at risk

Adverse event: Spinal column injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 121 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 121 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 121 at risk

Adverse event: Dermatochalasis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 121 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 121 at risk
Study: NCT03350672

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT03350750

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization for Grade 3 Generalized Muscle Weakness
Frequency: 1 affected / 9 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization for Septic urinary tract infection (UTI)
Frequency: 1 affected / 9 at risk

Adverse event: Subdural effusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Acute cholecystitis necrotic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Transient Decrease in MOCA Score
Serious: no
Organ System: Investigations
Frequency: 4 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal cramping
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Notes: Residual balance issues
Frequency: 1 affected / 9 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke
Frequency: 1 affected / 9 at risk

Adverse event: Transient Decrease in MOCA Score
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: External head trauma
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal cramping
Frequency: 1 affected / 9 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever of unknown origin
Frequency: 1 affected / 9 at risk
Study: NCT03350984

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 39 at risk

Adverse event: Acute respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 36 at risk

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

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk
Study: NCT03351101

Adverse event: Corneal infiltrates
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 132 at risk
Study: NCT03351335

Adverse event: Bruising/Ecchymosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 21 at risk

Adverse event: Erythema/Redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Oedema
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 21 at risk

Adverse event: Itching/Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Tenderness/Soreness/Pain/ Sensitivity to Touch
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Skin Pigmentation Change (Hypo-, Hyperpigmentation)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Bruising/Ecchymosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Tingling/Paresthesia/Numbness/ Nerve-related transient pain
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Welting/Raised Areas of Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT03351933

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 28 at risk

Adverse event: Vascular access site haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 28 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 28 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk
Study: NCT03351998

Adverse event: Cardiovascular event (SVT) unrelated to intervention
Serious: yes
Organ System: Cardiac disorders
Notes: Participant was diagnosed with an SVT that required hospitalization.
Frequency: 1 affected / 23 at risk

Adverse event: COVID-19
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Muscle or Joint Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 23 at risk

Adverse event: Adverse event related to testing for study
Serious: no
Organ System: Investigations
Notes: Any mild to moderate adverse reaction to the testing procedures for the study. Examples include vein irritation after IVGTT, bruise or swelling at biopsy site.
Frequency: 2 affected / 23 at risk

Adverse event: COVID-19
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Muscle or Joint Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 24 at risk

Adverse event: Adverse event related to testing for study
Serious: no
Organ System: Investigations
Notes: Any mild to moderate adverse reaction to the testing procedures for the study. Examples include vein irritation after IVGTT, bruise or swelling at biopsy site.
Frequency: 5 affected / 24 at risk

Adverse event: Sinus Infection/Flu Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Muscle or Joint Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 21 at risk

Adverse event: Adverse event related to testing for study
Serious: no
Organ System: Investigations
Notes: Any mild to moderate adverse reaction to the testing procedures for the study. Examples include vein irritation after IVGTT, bruise or swelling at biopsy site.
Frequency: 2 affected / 21 at risk

Adverse event: Sinus Infection/Flu Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk
Study: NCT03352011

Adverse event: ER visit or hospitalization unrelated to study interventions
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: ER visit or hospitalization unrelated to study interventions
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 25 at risk
Study: NCT03352245

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Ankle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT03352323

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk
Study: NCT03352414

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 42 at risk

Adverse event: Rectal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Non-Serious Adverse Events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 35 affected / 42 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 42 at risk

Adverse event: Non-Serious Adverse Events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 37 affected / 42 at risk
Study: NCT03352453

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 64 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Depressive symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 64 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 72 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Depressive symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 72 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Mitral valve prolapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 72 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 72 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 72 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 72 at risk
Study: NCT03352609

Adverse event: Slight scalp discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Immediately resolved
Frequency: 1 affected / 2 at risk

Adverse event: Mild Nausea
Serious: no
Organ System: General disorders
Notes: transient, self resolved
Frequency: 1 affected / 3 at risk
Study: NCT03353415

Adverse event: Depression
Serious: yes
Organ System: General disorders
Notes: Episode of severe depression requiring inpatient psychiatric hospitalization.
Frequency: 1 affected / 25 at risk

Adverse event: Skin irritation under Dexcom G4 sensor site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: # At risk consists of the 13 total participants using a Dexcom G4 sensor
Frequency: 2 affected / 13 at risk

Adverse event: Mild erythema under dexcom G4 sensor adhesive
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: # At risk consists of the 13 total participants using a Dexcom G4 sensor
Frequency: 1 affected / 13 at risk

Adverse event: Discomfort at site of Dexcom G4 sensor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: # At risk consists of the 13 total participants using a Dexcom G4 sensor
Frequency: 1 affected / 13 at risk

Adverse event: Hypoglycemia requiring emergency department evaluation
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Evaluated in the emergency department (transported from home) due to low glucose (50 mg/dL).
Frequency: 1 affected / 23 at risk
Study: NCT03353688

Adverse event: SAE2
Serious: yes
Organ System: Surgical and medical procedures
Notes: DBS lead placed suboptimally
Frequency: 1 affected / 31 at risk

Adverse event: SAE4
Serious: yes
Organ System: Psychiatric disorders
Notes: Panic attack
Frequency: 1 affected / 31 at risk

Adverse event: SAE5
Serious: yes
Organ System: Product Issues
Notes: Separation of product components post surgery
Frequency: 1 affected / 31 at risk

Adverse event: AE1
Serious: no
Organ System: Product Issues
Notes: Short circuit between DBS contacts
Frequency: 2 affected / 31 at risk

Adverse event: SAE1
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial infarction
Frequency: 1 affected / 31 at risk

Adverse event: SAE2
Serious: yes
Organ System: Surgical and medical procedures
Notes: DBS lead placed suboptimally
Frequency: 1 affected / 31 at risk

Adverse event: SAE3
Serious: yes
Organ System: Nervous system disorders
Notes: Postoperative seizure
Frequency: 1 affected / 31 at risk

Adverse event: SAE5
Serious: yes
Organ System: Product Issues
Notes: Separation of product components post surgery
Frequency: 1 affected / 31 at risk