Study: NCT03130257

Adverse event: Hospitalization: Back operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 172 at risk

Adverse event: Hospitalization: Surgery for enlarged prostate & bladder stones
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 172 at risk

Adverse event: Hospitalization: Surgery for removal appendix, bowel resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 172 at risk

Adverse event: Hospitalization: Bladder surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 172 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Discomfort, pain, irritation or bruisng from 24-hour monitor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 172 at risk

Adverse event: Sleep disruption
Serious: no
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 172 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 172 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Post-traumatic stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 172 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Gluten sensitivity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 172 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 172 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 172 at risk

Adverse event: Toe surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 172 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Low B12 and iron
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 172 at risk

Adverse event: Gall stones
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 172 at risk

Adverse event: Hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Gastrointestinal NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 172 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Hospitalization: Knee replacement surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 170 at risk

Adverse event: Discomfort, pain, irritation or bruisng from 24-hour monitor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 170 at risk

Adverse event: Sleep disruption
Serious: no
Organ System: General disorders
Frequency: 2 affected / 170 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 170 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Notes: Anxiety generated by using 24-hour BP monitor
Frequency: 3 affected / 170 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Swelling of hands, lips
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Plantar fasciitus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Leg/hip injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 170 at risk

Adverse event: Stomach flu/nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 170 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Respiratory track infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Acid reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 170 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 168 at risk

Adverse event: Severe allergic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Hospitalization: Surgery to implant stents
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 168 at risk

Adverse event: Discomfort, pain, irritation or bruisng from 24-hour monitor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 168 at risk

Adverse event: Sleep disruption
Serious: no
Organ System: General disorders
Frequency: 2 affected / 168 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 168 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 168 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Gastrointestinal NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Loss in erection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 168 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 168 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Respiratory track infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 168 at risk

Adverse event: Deteriorating vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 168 at risk

Adverse event: Carpal tunnel
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Thyroid nodules
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 168 at risk

Adverse event: Stress
Serious: no
Organ System: General disorders
Frequency: 1 affected / 168 at risk

Adverse event: Epigastric parasite infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Nerve damage from frostbite
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 168 at risk