Study: NCT00871715

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Recurrent Stroke or TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 119 at risk

Adverse event: MI or Acute Coronary Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: New onset of Cardiac Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 119 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 119 at risk

Adverse event: Inpatient Hospitalization or ER visit >23 hours
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 119 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Excessive blood pressure response
Serious: yes
Organ System: Vascular disorders
Notes: Of such severity that it required treatment discontinuation for the day
Frequency: 1 affected / 119 at risk

Adverse event: Unexpected/Other
Serious: yes
Organ System: General disorders
Notes: A serious adverse event that involves a condition/circumstance other than those expected and thus other than those pre-identified
Frequency: 2 affected / 119 at risk

Adverse event: Fall with No Fracture
Serious: no
Organ System: General disorders
Frequency: 41 affected / 119 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 119 at risk

Adverse event: Open sore or cuts
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 119 at risk

Adverse event: Muscle soreness or pain that persists for more than 48 hours
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 119 at risk

Adverse event: Shoulder pain that limits study participation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 119 at risk

Adverse event: Excessive blood pressure response
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 119 at risk

Adverse event: Dizziness/Fainting
Serious: no
Organ System: General disorders
Frequency: 10 affected / 119 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 119 at risk

Adverse event: Unexpected SAEs
Serious: no
Organ System: General disorders
Frequency: 10 affected / 119 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Recurrent Stroke or TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 120 at risk

Adverse event: MI or Acute Coronary Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 120 at risk

Adverse event: New onset of Cardiac Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 120 at risk

Adverse event: Inpatient Hospitalization or ER visit >23 hours
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 120 at risk

Adverse event: Excessive blood pressure response
Serious: yes
Organ System: Vascular disorders
Notes: Of such severity that it required treatment discontinuation for the day
Frequency: 1 affected / 120 at risk

Adverse event: Unexpected/Other
Serious: yes
Organ System: General disorders
Notes: A serious adverse event that involves a condition/circumstance other than those expected and thus other than those pre-identified
Frequency: 1 affected / 120 at risk

Adverse event: Fall with No Fracture
Serious: no
Organ System: General disorders
Frequency: 32 affected / 120 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 120 at risk

Adverse event: Open sore or cuts
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 120 at risk

Adverse event: Muscle soreness or pain that persists for more than 48 hours
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 120 at risk

Adverse event: Shoulder pain that limits study participation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 120 at risk

Adverse event: Excessive blood pressure response
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 120 at risk

Adverse event: Dizziness/Fainting
Serious: no
Organ System: General disorders
Frequency: 13 affected / 120 at risk

Adverse event: Unexpected SAEs
Serious: no
Organ System: General disorders
Frequency: 12 affected / 120 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 122 at risk

Adverse event: Recurrent Stroke or TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 122 at risk

Adverse event: MI or Acute Coronary Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 122 at risk

Adverse event: New onset of Cardiac Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 122 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 122 at risk

Adverse event: Inpatient Hospitalization or ER visit >23 hours
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 122 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 122 at risk

Adverse event: Excessive blood pressure response
Serious: yes
Organ System: Vascular disorders
Notes: Of such severity that it required treatment discontinuation for the day
Frequency: 3 affected / 122 at risk

Adverse event: Fall with No Fracture
Serious: no
Organ System: General disorders
Frequency: 23 affected / 122 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 122 at risk

Adverse event: Open sore or cuts
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 122 at risk

Adverse event: Muscle soreness or pain that persists for more than 48 hours
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 122 at risk

Adverse event: Shoulder pain that limits study participation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 122 at risk

Adverse event: Excessive blood pressure response
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 122 at risk

Adverse event: Dizziness/Fainting
Serious: no
Organ System: General disorders
Frequency: 9 affected / 122 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 122 at risk

Adverse event: Unexpected SAEs
Serious: no
Organ System: General disorders
Frequency: 7 affected / 122 at risk

Adverse event: Recurrent Stroke or TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 772 at risk

Adverse event: Inpatient Hospitalization or ER visit >23 hours
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 772 at risk

Adverse event: Excessive blood pressure response
Serious: yes
Organ System: Vascular disorders
Notes: Of such severity that it required treatment discontinuation for the day
Frequency: 1 affected / 772 at risk

Adverse event: Unexpected/Other
Serious: yes
Organ System: General disorders
Notes: A serious adverse event that involves a condition/circumstance other than those expected and thus other than those pre-identified
Frequency: 1 affected / 772 at risk

Adverse event: Excessive blood pressure response
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 772 at risk