Study: NCT01827462

Adverse event: Alcohol detoxification
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 59 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 59 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 59 at risk

Adverse event: Influenza Type Illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 59 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 59 at risk

Adverse event: Lower Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 37 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Calcium Channel Blocker Overdose
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Diminished Cognition
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Fractures/Accidents
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Surgery was not required with these fractures. All fractures due to falls or car collisions.
Frequency: 1 affected / 37 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 37 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Pancreatic Cancer
Frequency: 1 affected / 37 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Due to osteoarthritis, revision for failed hip arthroplasty (3), Avascular Necrosis (1), fall (1)
Frequency: 2 affected / 37 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Due to osteoarthritis -3
Frequency: 2 affected / 37 at risk

Adverse event: Bladder resection/transurethral
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery performed for Bladder Cancer
Frequency: 1 affected / 37 at risk

Adverse event: Hernia diaphragmatic repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 37 at risk

Adverse event: Microdiskectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Spinal stenosis
Frequency: 1 affected / 37 at risk

Adverse event: Pancreaticoduodenectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery performed for Ampulla Cancer
Frequency: 1 affected / 37 at risk

Adverse event: Perforated Pylric Ulcer repair
Serious: yes
Organ System: Surgical and medical procedures
Notes: Laparoscopic repair
Frequency: 1 affected / 37 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 37 at risk

Adverse event: Pacemaker Placement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Due to Atrial Fibrillaiton
Frequency: 1 affected / 37 at risk

Adverse event: Node Ablation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Due to Atrial Tachycardia
Frequency: 1 affected / 37 at risk

Adverse event: Aortic valve replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 37 at risk

Adverse event: Pancreatic stent placement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Obstruction due to pancreatic CA
Frequency: 1 affected / 37 at risk

Adverse event: Bile duct stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Notes: Obstruction due to pancreatic CA
Frequency: 1 affected / 37 at risk

Adverse event: Inferior Vena Cava Filter
Serious: yes
Organ System: Surgical and medical procedures
Notes: IVC filter placed as a precaution
Frequency: 1 affected / 37 at risk

Adverse event: Venoplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Right subclavian and brachiocephalic veins due to RUE thrombus
Frequency: 1 affected / 37 at risk

Adverse event: Amnesia-Tansient
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 37 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Notes: Stroke
Frequency: 1 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 37 at risk

Adverse event: Influenza Type Illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Lower Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 37 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 40 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 40 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypetension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: CHF
Frequency: 3 affected / 40 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Weakness Worsening
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Family reported death due to old age
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Family reported death due to advanced Alzheimer's
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Cause not determined.
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Prosthetic Hip Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Systemic Inflammatory Response Syndrone
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Scabies
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis
Frequency: 2 affected / 40 at risk

Adverse event: Fractures/Accidents
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Surgery was not required with these fractures. All fractures due to falls or car collisions.
Frequency: 3 affected / 40 at risk

Adverse event: Contusions/observation/hit by car
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Degenerative Joint Disease-pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Pancreatic Cancer
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Lung Canceer
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Ovarian Cancer
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Neuroendocrine Cancer
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: GI malignancy
Frequency: 1 affected / 40 at risk

Adverse event: Parkinson's
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Syncopal Episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pleural Effusions/bilateral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 40 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: Due to osteoarthritis, revision for failed hip arthroplasty (3), Avascular Necrosis (1), fall (1)
Frequency: 7 affected / 40 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 40 at risk

Adverse event: Pacemaker Placement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Due to Atrial Fibrillaiton
Frequency: 1 affected / 40 at risk

Adverse event: Arthrectomy-Femoral Artery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Claudication/PVD
Frequency: 1 affected / 40 at risk

Adverse event: Decompression of Lumbar Stenosis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 40 at risk

Adverse event: Femur Fracture Repair
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgical repair of Intertronchanteric femur fracture due to fall (2).
Frequency: 2 affected / 40 at risk

Adverse event: Cardioversion
Serious: yes
Organ System: Surgical and medical procedures
Notes: Elective for Atrial Fibrillation
Frequency: 1 affected / 40 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Peformed for cholelithiasis
Frequency: 1 affected / 40 at risk

Adverse event: Colectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery performed due to colon mass-Subtotal Colectomy with ileo-transverse colon anastomosis
Frequency: 1 affected / 40 at risk

Adverse event: Pancreatic stent placement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Obstruction due to pancreatic CA
Frequency: 1 affected / 40 at risk

Adverse event: Bile duct stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Notes: Obstruction due to pancreatic CA
Frequency: 1 affected / 40 at risk

Adverse event: Diverticulectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Zenker's diverticulum
Frequency: 1 affected / 40 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgical repair of ankle fracture due to fall
Frequency: 1 affected / 40 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 40 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Secondary to falls
Frequency: 2 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Notes: Subdural Hematoma
Frequency: 1 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Notes: Stroke
Frequency: 2 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lower Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk