Table 4. Mean daily urine volume changed from baseline (ITT population).
| Treatment period, Unit: mL | 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 to Day 1* | 45 | 1682.7 (861.3) | -- | 45 | 1568.2 (666.7) | -- | 114.53 (-208.13, 437.18) | 0.4824 |
| Day 1 to Day 2 | 45 | 2386.4# (1252.7) | 703.65 (1325.39) | 45 | 1671.6 (619.6) | 103.35 (605.37) | 665.77 (272.08, 1059.45) | 0.0012 |
| Day 2 to Day 3 | 44 | 2268.8# (1005.1) | 565.55 (1169.79) | 43 | 1689.8 (572.3) | 158.27 (602.44) | 522.21 (185.44, 858.99) | 0.0028 |
| Day 3 to Day 4 | 42 | 1988.4 (908.3) | 297.91 (1133.40) | 43 | 1673.4 (579.2) | 141.87 (606.76) | 267.79 (-48.33, 583.91) | 0.0958 |
| Day 4 to Day 5 | 42 | 1992.9# (748.8) | 302.48 (894.75) | 40 | 1654.9 (548.6) | 115.34 (708.68) | 289.64 (18.89, 560.38) | 0.0363 |
| EOS | 45 | 1902.1 (800.6) | 219.32 (928.74) | 45 | 1632.5 (539.9) | 64.23 (697.82) | 232.49 (-36.07, 501.05) | 0.0889 |
| Cumulative value (Day 1 to EOS) | 45 | 8320.7 (3690.0) | -- | 45 | 6356.3 (2141.1) | -- | 1820.5 (612.95, 3027.98) | 0.0036 |
| Mean daily urine | 45 | 2109.4# (871.8) | 426.61 (1020.07) | 45 | 1668.4 (451.9) | 100.23 (525.93) | 400.68 (130.41, 670.95) | 0.0041 |
Definition: EOS, end of study, the data represented with the urine volume from Day 4 to Day 5 analyzed with the last observation carried forward (LOCF) method. 95% CI, confidence interval; SD, standard deviation.
* The urine volume collected from the day before treatment Day 1 was defined as baseline. # With significant mean change compared to baseline value (intra p value < 0.05).
p value: pair t-test for intragroup comparison; Post-Baseline ANCOVA Model: outcome = treatment + baseline level.