This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011\~31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.
This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.
Study Type
OBSERVATIONAL
Enrollment
908
Bong Seng Hospital
Busan, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Safety Measure
Adverse Events (AEs)
Time frame: 4days
Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit
In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit
Time frame: Follow-up at least 4 days after first Samsca® dose
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