Table 3.
Adverse Events during 72 hours of treatment | No drops < 32°C (N=58) | Temp. < 32°C during induction or maintenance (N=43) | p-value (Fisher’s Exact Test) | ||
---|---|---|---|---|---|
N | % | N | % | ||
Cardiac arrhythmia | 2 | 3 % | 0 | 0 % | 0.51 |
Metabolic acidosis | 1 | 2 % | 1 | 2 % | 1.00 |
Thrombosis | 0 | 0 % | 0 | 0 % | N/A |
Bleeding | 3 | 5 % | 0 | 0 % | 0.26 |
Alteration of skin integrity | 3 | 5 % | 1 | 2 % | 0.63 |
Death | 7 | 12 % | 6 | 14 % | 0.77 |
Any SAE | 11 | 19 % | 7 | 16 % | 0.80 |