Table 5.
Vital signs and laboratory data variations from baseline, evaluable safety population
| Vital signs | Gd-DOTA-MRI (n = 70) | Unenhanced MRI (n = 44) | Student’s t-test |
|---|---|---|---|
| Diastolic blood pressure (mmHg) (mean ± SD, min/max) | |||
| 15 min | (n = 64) | (n = 41) | P = 0.427 |
| 2.84 ± 10.73 | 1.15 ± 10.48 | ||
| (−20/31) | (−21/35) | ||
| 1 h | (n = 60) | (n = 40) | P = 0.173 |
| 0.62 ± 11.58 | −2.25 ± 7.76 | ||
| (−20/42) | (−19/19) | ||
| Systolic blood pressure (mmHg) (mean ± SD, min/max) | |||
| 15 min | (n = 64) | (n = 41) | P = 0.067 |
| 4.84 ± 16.52 | −1.29 ± 16.58 | ||
| (−30/50) | (−39/40) | ||
| 1 h | (n = 60) | (n = 40) | P = 0.044 |
| 1.62 ± 17.86 | −5.70 ± 17.14 | ||
| (−36/60) | (−47/35) | ||
| Heart rate (bpm) (mean ± SD, min/max) | |||
| 15 min | (n = 63) | (n = 40) | P = 0.501 |
| 0.62 ± 12.15 | 2.00 ± 5.47 | ||
| (−56/34) | (−11/12) | ||
| 1 h | (n = 59) | (n = 40) | P = 0.568 |
| 0.90 ± 9.66 | 1.95 ± 7.80 | ||
| (−22/35) | (−15/16) | ||
| Laboratory data | Gd-DOTA-MRI (n = 70) | Unenhanced MRI (n = 44) | Student’s t-test |
| Laboratory data – relative variations from baseline values (mean ± SD, min/max) | |||
| Bicarbonate | (n = 65) | (n = 30) | P = 0.423 |
| −0.01 ± 0.09 | 0.01 ± 0.11 | ||
| (−0.22/0.23) | (−0.23/0.35) | ||
| Calcium | (n = 64) | (n = 40) | P = 0.825 |
| −0.01 ± 0.04 | −0.00 ± 0.04 | ||
| (−0.13/0.15) | (−0.14/0.09) | ||
| Haematocrit | (n = 67) | (n = 40) | P = 0.364 |
| −0.02 ± 0.05 | −0.01 ± 0.07 | ||
| (−0.17/0.12) | (−0.17/0.24) | ||
| Haemoglobin | (n = 67) | (n = 41) | P = 0.345 |
| −0.02 ± 0.04 | −0.01 ± 0.07 | ||
| (−0.16/0.10) | (−0.16/0.30) | ||
| Potassium | (n = 69) | (n = 43) | P = 0.426 |
| −0.01 ± 0.08 | −0.02 ± 0.09 | ||
| (−0.20/0.23) | (−0.24/0.19) | ||
| Sodium | (n = 70) | (n = 43) | P = 0.646 |
| 0.00 ± 0.02 | −0.00 ± 0.01 | ||
| (−0.04/0.04) | (−0.05/0.02) | ||
| Uric acid | (n = 61) | (n = 41) | P = 0.197 |
| −0.01 ± 0.08 | −0.03 ± 0.11 | ||
| (−0.16/0.17) | (−0.29/0.26) | ||