Study: NCT00650936

Adverse event: Abnormal Lab Value
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Acute Life Threatening Event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Air Embolus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Anemias
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Aortic Aneurysms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Arteriovenous (AV) Fistula
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1000 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Breath Holding Spell
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Cardiac Erosion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Elective procedure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Haematuria
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Migraine
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Palpitations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: ST Segment Changes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: SVC Syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Stridor
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Surgical Closure of ASD
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1000 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Vaso Vagal Response
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 1000 at risk

Adverse event: Abdominal Coagulation Parameter
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Abdominal Lab Value
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Accelerated idioventricular rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Nodal rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Acute Otitis Media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Acute pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Allergic Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Anesthesia Reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1000 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Antidromic Reciprocating Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Antral Erosion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Aortic Root Dilation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Aortic Valve Regurgitation and Insufficiency/Valvular Regurgitation Aortic Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1000 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 1000 at risk

Adverse event: Atrial Ectopic Beats and Rhythm / Premature Atrial Beats and Contractions
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 1000 at risk

Adverse event: Atrial Escape Beat
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 1000 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1000 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1000 at risk

Adverse event: Aura
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1000 at risk

Adverse event: Bacterial Infection of the Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Behavioral Alterations
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Biventricular Hypertrophy / Combined Ventricular Hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 19 affected / 1000 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Borderline Prolongation of QT Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Brachial plexus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1000 at risk

Adverse event: Broad QRS Complex Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Bruise/Purpura Simplex
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 59 affected / 1000 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 86 affected / 1000 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Common Cold / Upper Respiratory Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1000 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Coronary Artery Anomaly
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Decreased Exercise Tolerance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Dental Trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Device embolisation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1000 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Diastolic dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Difficulty Catching Breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Dilated Main Pulmonary Artery (MPA)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 17 affected / 1000 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 1000 at risk

Adverse event: EKG Abnormalities
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Echo Finding
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 1000 at risk

Adverse event: Elective surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1000 at risk

Adverse event: Emesis / Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 1000 at risk

Adverse event: Enlarged or Dilated Left Atrium (LA)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Epididymitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 18 affected / 1000 at risk

Adverse event: Fainting / Blackout
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Fatigue / General Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1000 at risk

Adverse event: Febrile Seizures
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 1000 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1000 at risk

Adverse event: First Degree Heart / AV Block / Cardiac Arrhythmia / First Degree AV Block
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 1000 at risk

Adverse event: Foreign Bodies
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Gastrointestinal Illness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Head and Neck Abscesses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 55 affected / 1000 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Frequency: 27 affected / 1000 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1000 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 1000 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 1000 at risk

Adverse event: Increased Left Atrial Pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Increased PR Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Interventricular Conduction Delay
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Inverted T Wave
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Irregular Menstrual Period
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Junctional Escape Rhythm / Intermittent Junctional Rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1000 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Lacerations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Left Axis Deviation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Left Ventricular Hypertrophy (by EKG)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Left Ventricular Hypertrophy (by Echo)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Long Q-T
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Back pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Low/ Coronary Atrial Rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1000 at risk

Adverse event: Lower Left Lobe Infiltrate
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Mid-Sternal Chest Pressure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 27 affected / 1000 at risk

Adverse event: Mitral valve prolapse
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Mitral Valve Regurgitation / Mitral Insufficiency
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1000 at risk

Adverse event: Multiple Calcified Granulomata in the Lung Fields
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1000 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 12 affected / 1000 at risk

Adverse event: Allergy to metals
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 1000 at risk

Adverse event: Non-Specific EKG Change
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1000 at risk

Adverse event: Obstructive sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Orthostatic hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 1000 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 1000 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 1000 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1000 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Premature Ventricular Contraction
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 1000 at risk

Adverse event: Presyncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Pulmonary Nodule
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Regular Narrow QRS Tachycardia / Supraventricular Tachycardias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Residual Interatrial Communication
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Residual Shunt
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Respiratory Illness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Right atrial enlargement
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Right Axis Deviation
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1000 at risk

Adverse event: Right Bundle Branch Block / Complete Right Bundle Branch Block
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Right Ventricular Conduction Delay
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Right ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1000 at risk

Adverse event: ST Segment Changes
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: ST-T-Wave Abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Seizure / Convulsions Epilepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Sinus Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1000 at risk

Adverse event: Sinus Bradycardia / Sinus Bradycardia (Cardiac Arrhythmia)
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 1000 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 1000 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Skin Lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Snoring
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1000 at risk

Adverse event: Strep Throat
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1000 at risk

Adverse event: T-Wave Abnormalities
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: T-Wave Inversion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Ureteral Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Urinary Calculi
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1000 at risk

Adverse event: VASC Bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1000 at risk

Adverse event: VASC Bruise
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1000 at risk

Adverse event: VASC Hematoma
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1000 at risk

Adverse event: VASC Pain
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1000 at risk

Adverse event: VASC Pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1000 at risk

Adverse event: Vaso Vagal Response
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1000 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 1000 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1000 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1000 at risk