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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.