NCT05131100已完成不适用
KOREAN POST-MARKETING SURVEILLANCE FOR SOMAVERT
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of participants who experience adverse events
研究概览
简要总结
Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.
排除标准
- •Patients who are contraindicated for Somavert
研究组 & 干预措施
Participants receiving Somavert
干预措施: Somavert (Drug)
结局指标
主要结局
Number of participants who experience adverse events
时间窗: Baseline through 28 days after last dose (approximately 52 weeks)
次要结局
- Number of participants who experience Clinical Improvement as assessed by investigator(Baseline through approximately 52 weeks)
研究者
研究点 (1)
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