Study: NCT00465270

Adverse event: Atrial septal defect
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Acute Bacterial Endocarditis (ABE)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute Erosive Gastritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Allergic Drug Reaction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Altered Sensorium
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Anemias
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Aortic Aneurysms
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Arthritis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Asthma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 499 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Bacterial Infections of the Skin
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 499 at risk

Adverse event: Burns
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac Thrombus
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cervical Stenosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 499 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Chills/Rigors
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Choledochal Cysts
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Choledocholithiaisis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Colitis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Conversion disorder
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Cutaneous Abcesses
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Depression
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Disc Protrusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Dysarthria/Slurred Speech
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 499 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Fenestrated Atrial Septum
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Fracture
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 499 at risk

Adverse event: Generalized Seizures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Generalized Tonic-Clonic Seizures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hemiparesis/Weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Infective/Bacterial Endocarditis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Intraparenchymal Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ischemic Eighth Nerve
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 499 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Leukemias
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Long Q-T
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Migraine
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 499 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 499 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Neck pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Non-Endpoint Transient Ischemic Attack (TIA)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Obesity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Osteoarthritis/Degenerative Joint Disease
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Other - SIRS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Other - Splenic infarcts
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Palpitations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Panic attack
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Peripheral Arterial Occlusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Peripheral Venous Thrombus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Possible Seizure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Prostate Discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pulmonary AVM
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 499 at risk

Adverse event: Residual Shunt Requiring Closure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Respiratory Illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Right Hepatic Trocar Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Seizure Disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Spells
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: TEE-Related Event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 499 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Female sterilisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Unmasking Old Stroke Symptoms
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Urinary Calculi
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: VASC Hematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Vaginal Child Birth
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 499 at risk

Adverse event: Vaso Vagal Response
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Vertigo
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Wound infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Acute pulmonary oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Allergic Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 499 at risk

Adverse event: Allergic Dye Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Asthma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atelectasis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm
Serious: no
Organ System: General disorders
Frequency: 10 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 499 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Borderline Prolongation of QT Interval
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Bruise/Purpura Simplex
Serious: no
Organ System: General disorders
Frequency: 46 affected / 499 at risk

Adverse event: Buzzing In Chest
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cardiac Thrombus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cellulitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 47 affected / 499 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Couplet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dental Trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Device Malposition or Malfunction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Difficulty Catching Breath
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Drug eruption
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 499 at risk

Adverse event: Emesis/Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 499 at risk

Adverse event: Fainting/Blackout
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastritis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gastrointestinal Illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 499 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Heaviness of Legs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Hypoxia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Increased Shunt
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Instillation site foreign body sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Low Hematocrit
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Meralgia paraesthetica
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Mid-Sternal Chest Pressure
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 11 affected / 499 at risk

Adverse event: Non-Specific EKG Change
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 499 at risk

Adverse event: Pain Due to a Catheter Drainage Tube
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 42 affected / 499 at risk

Adverse event: Paresthesia/Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: Pinching Sensation in Chest
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Presyncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pruritus/Itching
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Right Axis Deviation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Right Bundle Branch Block/Complete Right Bundle Branch Block
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: ST Segment Changes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: ST-T Wave Abnormality
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 499 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 499 at risk

Adverse event: T-Wave Abnormalities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: TEE-Related Event
Serious: no
Organ System: General disorders
Frequency: 10 affected / 499 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 499 at risk

Adverse event: VASC Bleeding
Serious: no
Organ System: General disorders
Frequency: 16 affected / 499 at risk

Adverse event: VASC Bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 499 at risk

Adverse event: VASC Hematoma
Serious: no
Organ System: General disorders
Frequency: 36 affected / 499 at risk

Adverse event: VASC Pain
Serious: no
Organ System: General disorders
Frequency: 32 affected / 499 at risk

Adverse event: Vaso Vagal Response
Serious: no
Organ System: General disorders
Frequency: 6 affected / 499 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Abnormal Lab Value
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Allergic Device Reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Anterior Meniscus Tear
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Arterial Hypertension/Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Asthma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 481 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Bacterial Infections of the Skin
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Benign Mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Birth Defect
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Brain Abcess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Burns
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 481 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 481 at risk

Adverse event: Cerebral Aneurysm
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Cerebral Infarct - Asymptomatic***
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Cerebrospinal Fluid (CSF) Leak
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Cervical Stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 481 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 481 at risk

Adverse event: Chronic Obstructive Airway Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Colitis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Common Cold/Upper Respiratory Tract Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Cutaneous Abcesses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Deep Vein/Venous Thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Delirium
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Depression
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 481 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Small intestine carcinoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 481 at risk

Adverse event: Emesis/Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Eye Lacerations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Gastritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 481 at risk

Adverse event: Generalized Seizures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Generalized Tonic-Clonic Seizures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Hip Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Homicide
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 481 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Intraparenchymal Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 481 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Lacerations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Melaena
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Migraine
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 481 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 481 at risk

Adverse event: Obesity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Osler Weber Rendu Syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Osteoarthritis/Degenerative Joint Disease
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 481 at risk

Adverse event: Other - Preterm labor
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Palpitations
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Paresthesia/Paraesthesia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 481 at risk

Adverse event: Pneumonia Caused By Haemophilus Influenzae
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Possible Seizure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pregnancy Related Symptoms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Premature Ventricular Contraction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Seizure Disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Simple partial seizures
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Spells
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 481 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Thyroid Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 481 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Female sterilisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Uncontrolled Blood Sugar
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Unmasking Old Stroke Symptoms
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Urinary Calculi
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Vaginal Child Birth
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 481 at risk

Adverse event: Vaso Vagal Response
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Vertigo
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Worsening Vision
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Abnormal Coagulation Parameter
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Acute Erosive Gastritis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Allergic Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 8 affected / 481 at risk

Adverse event: Bruise/Purpura Simplex
Serious: no
Organ System: General disorders
Frequency: 26 affected / 481 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 481 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 481 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 481 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Gastritis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 481 at risk

Adverse event: Haematochezia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Haematuria
Serious: no
Organ System: General disorders
Frequency: 2 affected / 481 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: General disorders
Frequency: 5 affected / 481 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Postmenopausal haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Pruritus/Itching
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: TEE-Related Event
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: VASC Hematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk

Adverse event: Vaso Vagal Response
Serious: no
Organ System: General disorders
Frequency: 1 affected / 481 at risk