Evaluation of Clinical Effects Body weight was measured
from baseline (BL) throughout the treatment periods, and changes
in body weight at day 14 from BL were evaluated. Urine
samples for determining cumulative 24-h urine volume were
collected from BL through the consecutive treatment periods as
were blood samples for clinical laboratory tests. For the evaluation
of body weight and clinical laboratory tests, BL was
defined as the values immediately before initiation of treatment
with tolvaptan. For the evaluation of urine volume, BL was
defined as the cumulative 24-h urine volume on the day before
starting tolvaptan