Supplement Table 5. Severity change in patient self-assessed global clinical status after 4-day of treatment.
Tolvaptan (N = 46) | Placebo (N = 45) | p value | |
Patient self-assessed global clinical status | |||
Baseline | |||
Mean | 51.4 ± 23.6 | 50.0 ± 21.1 | 0.7789 |
End of study | |||
Mean | 69.8 ± 28.2 | 73.3 ± 19.5 | |
Mean change from baseline | 18.26 ± 23.89 | 23.32 ± 25.42 | 0.3536 |
Patient self-assessed dyspnea | |||
Status at baseline, n (%) | 0.8243* | ||
Yes | 30 (65.2%) | 31 (68.9%) | |
No | 16 (34.8%) | 14 (31.1%) | |
Change from baseline at end of study, n (%) | 0.7717 | ||
Markedly better | 9 (19.6%) | 8 (17.8%) | |
Moderately better | 19 (41.3%) | 19 (42.2%) | |
Minimally better | 13 (28.3%) | 9 (20.0%) | |
No change | 3 (6.5%) | 9 (20.0%) | |
Moderately worse | 2 (4.3%) | 0 (0.0%) |
Definition: End of study, the data measured at the post-dosing examination visit after 4-day treatment.
p value: pair t-test for intragroup comparison; Post-Baseline ANCOVA Model was used in patient self-assessed global clinical status: outcome = treatment + baseline level; proportional odds model at Post-Baseline Visit was used in patient self-assessed dyspnea: outcome = treatment + baseline level (ordinal).
* The p value was tested by Fisher’s Exact Test.