Study: NCT01681095

Adverse event: Profuse bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Approximately 2 hours post-op the subject returned to the OR for re-exploration, finding right ventricular tear. This event was unexpected, and no action was taken with repect to the study drug.
Frequency: 1 affected / 55 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: 1 day post-op, head CT for stroke like sx showing acute cerebral infarct. Con-med changes for L Carotid 30-50% narrowing. Not related to study compound, not related to underlying disease, unexpected. Resolved with sequelae within 9 days.
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ER presentation with hospital admission. Chest x-ray confirming dx. Con-med change. SAE due to hospitalization, not related to study compound, possibly related to underlying disease, unexpected event
Frequency: 1 affected / 55 at risk

Adverse event: A-Fib or fA-Flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 55 at risk

Adverse event: Trombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 55 at risk

Adverse event: Heart Block (complete, 1st AV, 2 AV, 3 AV)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 55 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Bleeding (any)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 55 at risk

Adverse event: Acute blood loss anemina/any anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 55 at risk

Adverse event: Nodal rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 55 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Acute Kidney Failure/Renal Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dx 2 days post-op requiring reintubation on 12/19/2012, resolving 1/17/2013, considered an SAE due to prolonged hospitalization, impairment of body structure or body function (Trach on 12/23/2012), unexpected, possibly related to underlying disease.
Frequency: 1 affected / 55 at risk

Adverse event: Acute chest pain, shortness of breath
Serious: yes
Organ System: Cardiac disorders
Notes: ER via EMS, L sided chest pain and SOB. Cardiac eval performed. ECG, chest x-ray and labs normal. Admitted for evaluation; the condition resolved. SAE due to hospitalization; unexpected, not related to drug, probably related to underlying disease.
Frequency: 1 affected / 55 at risk

Adverse event: Atrial Fib with rapid ventricular response
Serious: yes
Organ System: Cardiac disorders
Notes: PO day 8, EC visit for weakness, ECG demonstrates A-fib w/RVR. Remained in observation, sx resolving within24 hours.SAE due to hospitalization, possibly r/t cardioplegia and possibly underlying disease, unexpected event
Frequency: 1 affected / 55 at risk

Adverse event: SOB, peripheral edema, mouth pain 16 days post-op
Serious: yes
Organ System: Immune system disorders
Notes: Subject to ER via EMS. Con-med: Levaquin for pneumonia. Con-med change after evaluation. Resolving after 14days. Possibly r/t study compound, and an unexpected event.
Frequency: 1 affected / 55 at risk

Adverse event: Mediastinal bleed
Serious: yes
Organ System: Surgical and medical procedures
Notes: Mediastinal bleed repaired day of surgery and considered resolved. Not related to treatment, possible related to underlying disease and unexpected.
Frequency: 1 affected / 55 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Direct admit from follow-up appt. Fatigue, R groin incision weeping, Atrial flutter w/RVR. Con-med change for incision. Cardioversion. SAE for hospitalization. Resolved and doubtful related to study compound, possible underlying disease.
Frequency: 1 affected / 55 at risk

Adverse event: Femoral occlusion
Serious: yes
Organ System: Vascular disorders
Notes: c/o leg pain, decreased peripheral pulse. 8 days PO performed femoral endarterectomy. Not related to study compound, not related to underlying disease and an unexpected event
Frequency: 1 affected / 55 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Requiring vent support due to not able to extubate. SAE d/t prolonged hospitalization, not related to study compound, related to underlying disease, an unexpected event.
Frequency: 1 affected / 55 at risk

Adverse event: Emergent Coronary Bypass
Serious: yes
Organ System: Cardiac disorders
Notes: Hypoxia, hypotension following MVR. Treated 2 vessels via full sternotomy
Frequency: 1 affected / 55 at risk

Adverse event: A-Fib or fA-Flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 55 at risk

Adverse event: Trombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 55 at risk

Adverse event: Heart Block (complete, 1st AV, 2 AV, 3 AV)
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 55 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 55 at risk

Adverse event: Bleeding (any)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 55 at risk

Adverse event: Acute blood loss anemina/any anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 55 at risk

Adverse event: Nodal rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Acute Kidney Failure/Renal Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 55 at risk