NCT02545101已完成不适用
A Non Interventional, Retrospective Study on Real World Usage and Treatment Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to the SIADH.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
研究概览
简要总结
This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable.
- •Female and/or male patients aged 18 years and over.
- •Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.
排除标准
- •A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.
结局指标
主要结局
Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
时间窗: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)
The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).
次要结局
- Change in Sodium Levels 6 Weeks After Treatment Initiation(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
- Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)(Baseline)
- Change in Sodium Levels 24 Hours After Treatment Initiation(From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards)
- Time (Hours) to Sodium Normalisation(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
- Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)(Baseline)
- Time (Days) to Sodium Normalisation(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
- Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
- Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)(Baseline)
- Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study(From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards)
- Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia(Baseline)
研究者
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