Study: NCT03030222

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 33 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Head Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

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

Adverse event: Groin Abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

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

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

Adverse event: Osteoarthritis - left knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

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

Adverse event: Worsening Tricuspid Valve Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Cellulitis - bilateral legs
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Contusion - scalp
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dysuria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Exacerbation of Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 33 at risk

Adverse event: Exertional Angina
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gout
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Increased craving for sweets
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pulmonary Nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Quick Tempered
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abscess - bilateral - hips, buttocks and upper legs
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 33 at risk

Adverse event: Lower left extremity swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Worsening Gout
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Exacerbation of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: CardioMEMS device recalibration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Exacerbation of Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Gout
Serious: no
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Bilateral Handshaking
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Bursitis - left knee
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Decreased renal function
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dystrophic Toenails
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: ICD Battery Depletion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Melaena
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Restrictive Ventilatory Defect
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Worsening Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Worsening Urinary Urge Incontinence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Contusion - posterior lower left back
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk