Study: NCT00862641

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 176 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 176 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 176 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 176 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 176 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 176 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 176 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 356 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was reported after the follow-up visit.
Frequency: 1 affected / 356 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 356 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 69 affected / 356 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 356 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 44 affected / 356 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 19 affected / 356 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 356 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 356 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 356 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 356 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 356 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 356 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 151 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 151 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 151 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 4 affected / 151 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 151 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 151 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 151 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 316 at risk

Adverse event: Electrocardiogram change
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 316 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 316 at risk

Adverse event: Amyotrophic lateral sclerosis
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was reported after the follow-up visit.
Frequency: 1 affected / 316 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 316 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 316 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 316 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 35 affected / 316 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 20 affected / 316 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 316 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 316 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 316 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 316 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 316 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 316 at risk