TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02324920

Adverse event: Inguinal hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 64 at risk

Adverse event: Presyncope
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 64 at risk

Adverse event: unspecified pain around the chest/ pocket.
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: inappropriate pacing due to undersensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: Subtalar arthrodesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: lead was not properly connected to the pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 64 at risk

Adverse event: Presyncope
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 64 at risk

Adverse event: Keloid formation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: mild pocket bleeding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: fatigue (mild obstructive sleep apnea syndrome)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk
Study: NCT02324972

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

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

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 26 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 28 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 28 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk
Study: NCT02325466

Adverse event: GI Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: prolonged hospitalization
Frequency: 1 affected / 70 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk
Study: NCT02325518

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 20 affected / 98 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 98 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 103 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 103 at risk
Study: NCT02325713

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

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

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk
Study: NCT02325830

Adverse event: Acute Coronary Syndromes
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 87 at risk

Adverse event: Arrhythmia - Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 87 at risk

Adverse event: Arrhythmia - Ventricular Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Arrhythmia - Ventricular Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Arteriospasm coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: ICD Device Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Heart Failure Exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 87 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 87 at risk

Adverse event: Worsening of Mitral Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 87 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 87 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 87 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 87 at risk

Adverse event: Acute Coronary Syndromes
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Arrhythmia - Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Heart Failure Exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 33 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Intracerebral Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk
Study: NCT02326233

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 95 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 95 at risk

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 95 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 95 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 95 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 95 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 94 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 94 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 94 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 94 at risk
Study: NCT02326363

Adverse event: Relapse to Substance Use Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 98 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 98 at risk

Adverse event: Gallbladder surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 98 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Aneursym
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 98 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 98 at risk

Adverse event: Relapse to Substance Use Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 106 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 106 at risk

Adverse event: Hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: iron defficiency
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Occipital Fracture
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 106 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 106 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 106 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 106 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 106 at risk
Study: NCT02326467

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: One subject experienced anemia that was identified with pre-operative lab work. The subject was placed on study hold for anemia and post-op recovery. The anemia resolved post-op. This was not deemed a serious adverse event.
Frequency: 2 affected / 9 at risk
Study: NCT02326844

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vascular disorders - Other, bleeding gums
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk
Study: NCT02326883

Adverse event: Self-harm leading to death or hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 71 affected / 6230 at risk

Adverse event: Self-harm leading to death or hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 92 affected / 6227 at risk

Adverse event: Self-harm leading to death or hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 69 affected / 6187 at risk
Study: NCT02327143

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk
Study: NCT02327195

Adverse event: Mild QTc prolongation
Serious: yes
Organ System: Cardiac disorders
Notes: Mild QTc prolongation
Frequency: 11 affected / 27 at risk

Adverse event: Mild QTc prolongation
Serious: yes
Organ System: Cardiac disorders
Notes: Mild QTc prolongation
Frequency: 11 affected / 27 at risk
Study: NCT02327325

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization due to fall resulting in multiple fractures
Frequency: 1 affected / 20 at risk

Adverse event: Hospitalizatoin
Serious: yes
Organ System: Renal and urinary disorders
Notes: Hospitalization for acute renal failure injury secondary to volume depletion
Frequency: 1 affected / 20 at risk
Study: NCT02327351

Adverse event: CMV pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: ADV hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 98 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 98 at risk

Adverse event: TMA
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 98 at risk
Study: NCT02327403

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac arrest leading to death
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: MRSA Cellulitis with Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Due to interstitial inflammation
Frequency: 1 affected / 15 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Recurrence of Bladder Tumor
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk
Study: NCT02327741

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 502 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 502 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 508 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 508 at risk
Study: NCT02328326

Adverse event: Cardiac Events
Serious: yes
Organ System: Cardiac disorders
Notes: 3 patient participants (PT) had heart attacks; 1 PT in hospital for "heart issues"; 1 PT hospitalized CHF; 1 PT hospitalized arrythmia
Frequency: 6 affected / 246 at risk

Adverse event: Vascular Issues
Serious: yes
Organ System: Vascular disorders
Notes: 2 patient participants (PT) hospitalized for high blood pressure (1 intervention, 1 control); 1 PT hospitalized low blood pressure; 1 PT in emergency room for blood clot
Frequency: 3 affected / 246 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: 1 patient participant (PT) hospitalized due to infection; 1 PT hospitalized for sepsis; 1 PT eye infection; 1 PT sinus infection.
Frequency: 4 affected / 246 at risk

Adverse event: Surgeries
Serious: yes
Organ System: Surgical and medical procedures
Notes: 2 patient participants (PT) had lower limb amputations; 1 PT hand injury \& surgery; 1 PT emergency intestinal surgery
Frequency: 4 affected / 246 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 1 patient participant (PT) broken bone in lower limb; 1 PT car accident; 2 PTs broken bones or dislocations upper limbs
Frequency: 4 affected / 246 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: 4 patient participants (PT) had strokes, all withdrew. 2 PT hospitalized for passing out, one had renal failure also; 1 PT in and out of hospital since stroke; 1 PT withdrawn by Care partner because not cognitively present
Frequency: 4 affected / 246 at risk

Adverse event: General Diagnoses, Hospitalizations
Serious: yes
Organ System: General disorders
Notes: 1 Control patient participant (PT) admitted to hospital (no reason provided ; 1 PT diagnosed cancer
Frequency: 2 affected / 246 at risk

Adverse event: Social Circumstances
Serious: yes
Organ System: Social circumstances
Notes: 1 PT lost housing
Frequency: 1 affected / 246 at risk

Adverse event: Multiple Issues
Serious: yes
Organ System: General disorders
Notes: One Patient participant had a stroke, kidney stones
Frequency: 1 affected / 246 at risk

Adverse event: Vascular Issues
Serious: yes
Organ System: Vascular disorders
Notes: 2 patient participants (PT) hospitalized for high blood pressure (1 intervention, 1 control); 1 PT hospitalized low blood pressure; 1 PT in emergency room for blood clot
Frequency: 1 affected / 232 at risk

Adverse event: General Diagnoses, Hospitalizations
Serious: yes
Organ System: General disorders
Notes: 1 Control patient participant (PT) admitted to hospital (no reason provided ; 1 PT diagnosed cancer
Frequency: 1 affected / 232 at risk