Post Marketing Surveillance of Mircera®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 748
- 主要终点
- Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event
研究概览
简要总结
This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult, aged >18 years
- •Participants with stage 3-5 chronic kidney disease and hemodialyzed participants
- •Signed informed consent
排除标准
- •Current participation in a clinical study
研究组 & 干预措施
Overall Participants
Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera
干预措施: Mircera (Drug)
结局指标
主要结局
Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event
时间窗: At physician's discretion, up to 4 years
An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Percentage of Participants With an Adverse Drug Reaction (ADR)
时间窗: At physician's discretion, up to 4 years
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
次要结局
未报告次要终点