Study: NCT01020123

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 92 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 92 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 4 affected / 92 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 92 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 4 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 92 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 92 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 92 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 92 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 4 affected / 92 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 92 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 9 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 7 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 90 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 90 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 4 affected / 90 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 4 affected / 90 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 4 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 3 affected / 90 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 3 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 4 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 5 affected / 50 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 50 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 50 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 50 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 50 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 40 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 3 affected / 40 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 40 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 40 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 40 at risk

Adverse event: Renal failur acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 87 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 6 affected / 87 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 87 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 3 affected / 87 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 87 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 87 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 93 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 3 affected / 93 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 3 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 93 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 93 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 93 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 7 affected / 93 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 10 affected / 93 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 10 affected / 93 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 6 affected / 93 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 3 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 71 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 71 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 1 affected / 71 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: This iformation is based on tables 182 and 183 in the CSR
Frequency: 2 affected / 71 at risk