Post-Marketing Surveillance of Symbenda Injection (Bendamustine Hydrochloride) in Korean Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 9
- 主要终点
- Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
研究概览
简要总结
This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.
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
- •Patients who meet the following criteria will be eligible for inclusion in the study:
- •Patients with approved indication for Symbenda in Korea
- •Patients who have verbal or written consent for use of personal and medical information for the study purpose Investigators will refer to approved indications and contraindications regarding inclusion criteria.
排除标准
- •Investigators will refer to approved indications and contraindications regarding exclusion criteria.
结局指标
主要结局
Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
时间窗: Up to 6 months
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
次要结局
- Chronic lymphocytic leukemia response rate per National Cancer Institute-Sponsored Working Group (NCISWG) criteria to assess the tumor response(After 2nd cycle (each cycle = 28 days) up to 2 months)
- Multiple myeloma response rate per International Myeloma Working Group (IMWG) uniform response criteria to assess the tumor response(After 2nd cycle (each cycle = 28 days) up to 2 months)
- Non-Hodgkin's lymphomas response rate per Standardize Response Criteria for Non-Hodgkin's lymphomas to assess the tumor response(After 2nd cycle (each cycle = 28 days) up to 1.5 months)