Evaluation of the Effectiveness of Risk Minimization Measures: A Survey Among Pharmacists to Assess the Impact of the RMP Material for Patients on Promoting the Proper Use of NINLARO in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material
研究概览
简要总结
This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM).
The main aims of the study are:
- To assess the frequency of pharmacists who have provided patients with the contents of the RMP material for patients.
- To assess the frequency of pharmacists who have obtained the RMP material for patients.
- To evaluate the depth of understanding of proper usage of NINLARO among pharmacists.
详细描述
This is a prospective, non-interventional, observational web-based survey in pharmacists who have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone therapy to patients with rrMM. The study will assess the effectiveness of distributed RMP material in prevention of ixazomib overdose in Japanese clinical practice.
The study will enroll approximately 300 pharmacists who belong to hospitals prescribing NINLARO. The data will be collected through a self-administered web-based survey with questionnaires provided in Japanese.
This web-based survey will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material
时间窗: Up to Day 9
The NINLARO additional risk minimization measure (aRMM) effectiveness study questionnaire which was intended for pharmacists who instructed the dosing of IRD therapy to patients with relapsed/refractory multiple myeloma (RRMM). This outcome was based on the number of pharmacists who answered "Yes" to question 3; Do you instruct patients that they should take one capsule of NINLARO each time on an empty stomach for RRMM? Here, unit of measure: participants refer to pharmacists.
次要结局
- Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule(Up to Day 9)
- Number of Pharmacists Who Had Received the RMP Material for Patients(Up to Day 9)
- Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule(Up to Day 9)