A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- Incidence of serious adverse event after this drug administration in general medical practice
研究概览
简要总结
Post-marketing surveillance of Telostop Plus Tab.
详细描述
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient who is first prescribed and administered Telostop plus Tab.
排除标准
- •The patients who are overreacting to this drug or its components
- •The patients with severe renal impairment
结局指标
主要结局
Incidence of serious adverse event after this drug administration in general medical practice
时间窗: 24 weeks
Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events.
Incidence of adverse event after this drug administration in general medical practice
时间窗: 24 weeks
Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
次要结局
未报告次要终点