Table 1 Adverse Event Definitions
Event | Expected | Unexpected |
|---|---|---|
Brain Injury (Serious) | Demyelination Any text reference in imaging reports to 'Central Pontine Myelinosis or Pontine Hyperintensity' in any MRI report during hospital stay | Subarachnoid Hemmorhage Any text reference in imaging reports of CT of MRI within 24 hours of arrival to Emergency Department to 'Subarachnoid Hemmorhage or SAH' when the first CT scan was normal |
Anaphylactoid Reaction (Serious) | Any text reference in physician notes within the first 24 hours of arrival to Emergency Department to 'anaphylactoid reaction' | Â |
Prolonged Partial Thromboplastin Time (Non serious) | Normal up to 40 May see up to 85 with HSD | > 100 |
International Normalized Ratio (Non serious) | Normal up to 1.5 May see up to 3.0 with HSD | > 3.0 |
Serum Sodium (Non serious) | Normal range 135-147 May see up to 158 with HSD | > 160 |
Serum Osmolarity (Non serious) | Normal range 310-330 May see up to 350 with HSD without alcohol | > 350 without alcohols |
Serum Chloride (Non serious) | Normal range 96-108 May see up to 145 | >150 |
Rouleau formation (Non serious) | May be present | Â |