Study: NCT00086385

Adverse event: Death (not related to study)
Serious: yes
Organ System: General disorders
Notes: Ruled unrelated serious adverse event.
Frequency: 2 affected / 100 at risk

Adverse event: Dental Issues
Serious: no
Organ System: General disorders
Notes: Ruled unrelated adverse event.
Frequency: 1 affected / 100 at risk

Adverse event: Death (not related to study)
Serious: yes
Organ System: General disorders
Notes: Ruled unrelated serious adverse event.
Frequency: 2 affected / 99 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Ruled unrelated serious adverse event to the study. Hospitalized.
Frequency: 1 affected / 99 at risk

Adverse event: Heart Procedure
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Ruled unrelated serious adverse event. Hospitalized for a heart procedure.
Frequency: 1 affected / 99 at risk

Adverse event: Implantation of an Automatic Implantable Cardioverter Defibrillator
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Ruled unrelated serious adverse event. Hospitalized.
Frequency: 1 affected / 99 at risk

Adverse event: Dental Issues
Serious: no
Organ System: General disorders
Notes: Ruled unrelated adverse event.
Frequency: 1 affected / 99 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Ruled unrelated adverse event.
Frequency: 1 affected / 99 at risk

Adverse event: Numbness/Tingling
Serious: no
Organ System: Nervous system disorders
Notes: Ruled unrelated adverse event.
Frequency: 1 affected / 99 at risk

Adverse event: Death (not related to study)
Serious: yes
Organ System: General disorders
Notes: Ruled unrelated serious adverse event.
Frequency: 1 affected / 104 at risk

Adverse event: Asthma Attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Reported unrelated serious adverse event. Hospitalized.
Frequency: 1 affected / 104 at risk

Adverse event: Myocardial Infarct (MI)
Serious: yes
Organ System: Cardiac disorders
Notes: Reported unrelated serious adverse event. Hospitalized.
Frequency: 1 affected / 104 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Ruled unrelated serious adverse event. Hospitalized.
Frequency: 1 affected / 104 at risk

Adverse event: Biopsy lung
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Ruled unrelated adverse event.
Frequency: 1 affected / 104 at risk

Adverse event: Midsternal Pressure
Serious: no
Organ System: General disorders
Notes: Ruled directly related adverse event. Her blood pressure and heart rate were ruled normal by the study's staff. Subject was advise to discontinue gum use and seek appt with primary care provider.
Frequency: 1 affected / 104 at risk

Adverse event: Dental Issues
Serious: no
Organ System: General disorders
Notes: Ruled unrelated adverse event.
Frequency: 1 affected / 104 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Ruled unrelated adverse event.
Frequency: 1 affected / 104 at risk

Adverse event: Death (not related to study)
Serious: yes
Organ System: General disorders
Notes: Ruled unrelated serious adverse event.
Frequency: 1 affected / 99 at risk

Adverse event: Fatigue, Weakness, and Unsteady Walking
Serious: yes
Organ System: General disorders
Notes: Reported unrelated serious adverse event. Hospitalized.
Frequency: 1 affected / 99 at risk

Adverse event: Anxiety, High Blood Presure
Serious: no
Organ System: Psychiatric disorders
Notes: Ruled indirectly related adverse event. Subject discontinued study medication.
Frequency: 1 affected / 99 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Ruled unrelated adverse event.
Frequency: 2 affected / 99 at risk