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