Study: NCT00268762

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death that occured by any of the following causes: (brain herniation or respiratory failure)
Frequency: 7 affected / 65 at risk

Adverse event: Stroke progression or neurological worsening
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 65 at risk

Adverse event: Significant intracerebral hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Significant intracerebral hemorrhage defined as either:

1. Symptomatic intracerebral hemorrhage or
2. Parenchymal Hematoma - type 2
Frequency: 4 affected / 65 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 65 at risk

Adverse event: Pneumonia/respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 65 at risk

Adverse event: Asymptomatic ICH
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 65 at risk

Adverse event: Significant laboratory abnormality
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 65 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nausea with or without Emesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 65 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: This includes one patient with "Low Blood Pressure"
Frequency: 3 affected / 65 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 65 at risk

Adverse event: Patent Foramen Ovale
Serious: no
Organ System: Cardiac disorders
Notes: New diagnosis of patent foramen ovale.
Frequency: 1 affected / 65 at risk

Adverse event: Aortic valve vegetation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 65 at risk

Adverse event: Hypothermia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 65 at risk

Adverse event: Laboratory abnormalities - Chemistries
Serious: no
Organ System: General disorders
Notes: Elevated: Creatinine Kinase/troponin=6; Liver Function Tests=2; blood urea nitrogen (BUN)=1; myoglobin=1 ; Bilirubin=1; Ketones=1; Serum Creatinine=1; Hypoglycemia=1
Frequency: 10 affected / 65 at risk

Adverse event: New diagnosis of diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 65 at risk

Adverse event: Oliguria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Urinary Analysis laboratory abnormality
Serious: no
Organ System: Renal and urinary disorders
Notes: Leuko-Uria = 1 \& Hematuria = 2
Frequency: 3 affected / 65 at risk

Adverse event: Anemia/decrease in hemoglobin and hematocrit level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 65 at risk

Adverse event: Asymptomatic Intracranial Hemorhhage
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 65 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 65 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 65 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 65 at risk

Adverse event: Minimally displaced fracture of base of fifth metacarpal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 65 at risk

Adverse event: Agitation/lethargic/somnolent
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 65 at risk

Adverse event: Stroke progression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 65 at risk

Adverse event: Neuro-worsening
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 65 at risk

Adverse event: Exacerbation of uterine prolapse
Serious: no
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Excessive sleepness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: Self extubation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Visual hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: Right lung mass
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Coughing/gagging
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Both lung with rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 65 at risk

Adverse event: Hypoventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 65 at risk

Adverse event: Slight angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Laboratory Abnormalities - Electrolytes
Serious: no
Organ System: General disorders
Notes: Hypokalemia=5; Hyperkalemia=2; Hyponatremia=3; Hypernatremia=2; Hypocalcemia=3 Hypomagnesia=1; Hypophosphatemia=2; Electrolyte disorder not-specified=1
Frequency: 13 affected / 65 at risk

Adverse event: Laboratory Abnormalities - Elevated PTT >100 seconds
Serious: no
Organ System: General disorders
Frequency: 1 affected / 65 at risk