BL Characteristics
In total, 1,840 patients with HF were registered, and 1,059 case
report forms from 258 sites were collected; 4 were excluded
from the efficacy analysis because of off-label use, so 1,053 were
analyzed for efficacy. For the safety assessment, 2 were excluded
for violations of the enrollment criteria, so 1,057 were
assessed. Patients’ backgrounds and demographic data are
shown in Table 1. Mean age was 76 years, 56.3% were male,
33.8% had been prescribed tolvaptan for more than 2 weeks and
the prevalence of classes III and IV HF according to the NYHA