Study: NCT01876420

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Blood disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac Conduction Disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 60 at risk

Adverse event: Supraventricular arrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ischemic Coronary Artery Disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Decreased BP
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestianl Ulcers and Perforation, Site Unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: General Signs and Symptoms Nec
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 60 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 60 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal Failure and Impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Upper Respiratory Tract Signs and Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatitis Ascribed to Specific Agent
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Anaemias Nec
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 60 at risk

Adverse event: Thrombocytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Cardiac Conduction Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 60 at risk

Adverse event: Cardiac Disorders Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 60 at risk

Adverse event: Heart Failure Nec
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 60 at risk

Adverse event: Ischemic Coronary Artery Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Rate and Rhythm Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 60 at risk

Adverse event: Supraventricular Arrythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Gastrointestinal Atonic And Hypomobility
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal Atonic And HypomobilitySigns and Symptoms Nec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Febrile Disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Inflammations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Complication Associated with Device Nec
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Infections Nec
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 60 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 60 at risk

Adverse event: Non-site specific Injuries Nec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 60 at risk

Adverse event: Non-site specific Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 60 at risk

Adverse event: General Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 60 at risk

Adverse event: Headach Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Neurological Signs And Symptoms Nec
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Depressive Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 60 at risk

Adverse event: Renal Failure and Impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 60 at risk

Adverse event: Urinary Abnormalities
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 60 at risk

Adverse event: Vulvovaginal Disorder Nec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Coughing And Associated Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pneumothorax And Pleural Effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Dermatitis And Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Subcutaneous Tissue Ulcerations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk

Adverse event: Skin injuries And Mechanical Dermatoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 60 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 60 at risk

Adverse event: Aortic Valvular Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Ventricular Arrythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk