Study: NCT01807897

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of heart failure symptoms requiring hospitalization
Frequency: 1 affected / 31 at risk

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fall with injury requiring hospitalization
Frequency: 1 affected / 31 at risk

Adverse event: Increased dyspnea
Serious: no
Organ System: Cardiac disorders
Notes: Dyspnea new or worse shortness of breath since prior contact
Frequency: 5 affected / 31 at risk

Adverse event: Excessive sleepiness
Serious: no
Organ System: Nervous system disorders
Notes: Sleepiness interfering with work or driving since prior contact
Frequency: 2 affected / 31 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of heart failure symptoms requiring hospitalization
Frequency: 2 affected / 29 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial fibrillation requiring intervention
Frequency: 1 affected / 29 at risk

Adverse event: Increased dyspnea
Serious: no
Organ System: Cardiac disorders
Notes: Dyspnea new or worse shortness of breath since prior contact
Frequency: 4 affected / 29 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Notes: New or worse discomfort or pain in chest since prior contact
Frequency: 2 affected / 29 at risk

Adverse event: Excessive sleepiness
Serious: no
Organ System: Nervous system disorders
Notes: Sleepiness interfering with work or driving since prior contact
Frequency: 3 affected / 29 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Decreased renal function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fall with injury requiring hospitalization
Frequency: 1 affected / 14 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalized for chest pain
Frequency: 1 affected / 14 at risk

Adverse event: Increased dyspnea
Serious: no
Organ System: Cardiac disorders
Notes: Dyspnea new or worse shortness of breath since prior contact
Frequency: 2 affected / 14 at risk

Adverse event: Fall with injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk