NCT01376115已完成不适用
Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg
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
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice.
研究概览
简要总结
To investigate safety and efficacy on Japanese subjects treated with nelarabine injection for intravenous use in clinical settings of the following diseases:
- T-cell acute lymphocytic leukemia (T-ALL)
- T-cell lymphoblastic lymphoma (T-LBL) Also, "any adverse events involving neurological disorder, hypotension, and blood disorder and their details" are to be investigated as an item of particular concern. In addition, subject outcome (alive or dead) at one year after the start of treatment will also be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
排除标准
- •Subjects with hypersensitivity to nelarabine
研究组 & 干预措施
Subjects administered nelarabine
Subjects with T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) prescribed nelarabine during study period
干预措施: Nelarabine (Drug)
结局指标
主要结局
The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice.
时间窗: 1 year
Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details
时间窗: 1 year
次要结局
- Outcome (alive or dead) at one year after the start of treatment(1 year)
研究者
研究点 (1)
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