Table 3.
Efficacy analysis
| Efficacy variable | Study group (n = 125) | Control group (n = 138) | p-value |
|---|---|---|---|
| AUC of BT change at 6 h after administration-and-time relationship | 5.98 ± 3.87 | 5.78 ± 4.01 | 0.683 |
| BT reduction at 4 h after administration (°C) | 0.97 ± 0.90 | 1.16 ± 0.92 | 0.09 |
| Maximum value of BT reduction during the 6 h after administration (°C) | 1.63 ± 0.66 | 1.64 ± 0.70 | 0.855 |
| Number of patients whose BT normalized (< 37.0 °C) at 6 h after administration, n (%) | 26 (20.8) | 23 (16.7) | 0.390 |
| Time point when BT first reached < 37.0 °C, hour | 1.73 ± 1.29 | 2.13 ± 1.06 | 0.064 |
Results are presented as mean ± standard deviation or as a percentage (%)
BT Body Temperature
AUC Area Under the Curve