Study: NCT01826851

Adverse event: Cerebral vascular accident with permanent deficits
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: New onset SVT or ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 38 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 38 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 38 at risk

Adverse event: Bundle branch block
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 38 at risk

Adverse event: First Degree AV Block
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 38 at risk

Adverse event: Supraventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 38 at risk

Adverse event: Prolonged QT Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 38 at risk

Adverse event: Premature Ventricular Contraction
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 38 at risk

Adverse event: ST Changes
Serious: no
Organ System: Cardiac disorders
Notes: ST segment elevation or depression on electrocardiogram
Frequency: 2 affected / 38 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Excessive sweating
Frequency: 14 affected / 38 at risk

Adverse event: Dizziness/Light headedness
Serious: no
Organ System: General disorders
Frequency: 18 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Metallic Taste in Mouth
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 38 at risk

Adverse event: Generalized Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Parasthesias
Serious: no
Organ System: Nervous system disorders
Notes: Numbness
Frequency: 5 affected / 38 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Abnormal drowsiness
Frequency: 12 affected / 38 at risk

Adverse event: Tinnitis
Serious: no
Organ System: Nervous system disorders
Notes: Ringing in ears
Frequency: 6 affected / 38 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: New onset SVT or ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 41 at risk

Adverse event: New onset ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 41 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 41 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 41 at risk

Adverse event: Bundle branch block
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 41 at risk

Adverse event: First Degree AV Block
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 41 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 41 at risk

Adverse event: Prolonged QT Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 41 at risk

Adverse event: Premature Ventricular Contraction
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 41 at risk

Adverse event: ST Changes
Serious: no
Organ System: Cardiac disorders
Notes: ST segment elevation or depression on electrocardiogram
Frequency: 6 affected / 41 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 41 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 16 affected / 41 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Excessive sweating
Frequency: 14 affected / 41 at risk

Adverse event: Dizziness/Light headedness
Serious: no
Organ System: General disorders
Frequency: 22 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 41 at risk

Adverse event: Metallic Taste in Mouth
Serious: no
Organ System: General disorders
Frequency: 7 affected / 41 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 15 affected / 41 at risk

Adverse event: Generalized Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 41 at risk

Adverse event: Miosis
Serious: no
Organ System: Nervous system disorders
Notes: Pupillary constriction
Frequency: 3 affected / 41 at risk

Adverse event: Parasthesias
Serious: no
Organ System: Nervous system disorders
Notes: Numbness
Frequency: 13 affected / 41 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Abnormal drowsiness
Frequency: 12 affected / 41 at risk

Adverse event: Tinnitis
Serious: no
Organ System: Nervous system disorders
Notes: Ringing in ears
Frequency: 3 affected / 41 at risk