Supplement Table 3. Mean change in body weight from baseline to each post-baseline observation (PP population).
Treatment day, Unit: kg | Tolvaptan (N = 42) | Placebo (N = 39) | Adjust group difference (95% CI) | p value | ||||
N | Mean (SD) | Change (SD) | N | Mean (SD) | Change (SD) | |||
Day 1 (baseline) | 42 | 64.3 (14.5) | -- | 39 | 68.0 (15.0) | -- | -4.00 (-10.51, 2.52) | 0.2254 |
Day 2 | 42 | 63.1 (14.5) | -0.87 (1.20)* | 39 | 67.6 (14.8) | -0.36 (0.88)* | -0.53 (-1.00, -0.06) | 0.0292 |
Day 3 | 42 | 62.8 (14.3) | -1.18 (1.54)* | 39 | 67.4 (15.0) | -0.58 (1.07)* | -0.63 (-1.23, -0.04) | 0.0379 |
Day 4 | 41 | 63.3 (14.1) | -1.20 (1.94)* | 39 | 67.4 (15.0) | -0.60 (1.29)* | -0.64 (-1.38, -0.11) | 0.0918 |
Post-dosing Day 5 | 42 | 62.5 (14.6) | -1.45 (2.19)* | 39 | 67.3 (14.9) | -0.69 (1.31)* | -0.78 (-1.60, 0.04) | 0.0614 |
EOS | 42 | 62.5 (14.6) | -1.45 (2.19)* | 39 | 67.3 (14.9) | -0.69 (1.31)* | -0.78 (-1.60, 0.04) | 0.0614 |
Definition: Post-Dosing Day 5: treatment measurement at post Day 4 dosing examination visit. EOS, end of study, the data represented with the result of post-dosing day 5 analyzed with the last observation carried forward (LOCF) method.
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).