Table 3. Mean change in body weight from baseline to each post-baseline observation (ITT population).
Treatment day, Unit: kg | Tolvaptan (N = 46) | Placebo (N = 45) | Adjust group difference (95% CI) | p value | ||||
N | Mean (SD) | Change (SD) | N | Mean (SD) | Change (SD) | |||
Day 1 (baseline) | 46 | 64.3 (14.7) | -- | 45 | 68.0 (14.5) | -- | -3.77 (-9.84, 2.30)- | 0.2206 |
Day 2 | 46 | 63.4 (14.7) | -0.84 (1.17)* | 45 | 67.7 (14.3) | -0.31 (0.86)* | -0.55 (-0.98, -0.12) | 0.0136 |
Day 3 | 45 | 62.6 (14.2) | -1.13 (1.52)* | 43 | 67.9 (14.7) | -0.57 (1.06)* | -0.59 (-1.15, -0.02) | 0.0416 |
Day 4 | 42 | 62.9 (14.2) | -1.20 (1.92)* | 43 | 67.9 (14.7) | -0.54 (1.26)* | -0.69 (-1.40, -0.02) | 0.0571 |
Post-dosing Day 5 | 43 | 62.1 (14.7) | -1.45 (2.16)* | 40 | 67.8 (15.0) | -0.66 (1.31)* | -0.81 (-1.62, -0.01) | 0.0476 |
EOS | 46 | 62.9 (14.8) | -1.36 (2.13)* | 45 | 67.4 (14.4) | -0.59 (1.27)* | -0.78 (-1.52, -0.04) | 0.0394 |
Definition: EOS, end of study, the data represented with the result after 4-day tolvaptan treatment analyzed with the last observation carried forward (LOCF) method. 95% CI, confidence interval; SD, standard deviation.
p value: pair t-test for intragroup comparison; Post-Baseline ANCOVA Model: outcome = treatment + baseline level.
* With significant mean change compared to baseline value (intra p value < 0.05).