Special Drug Use-results Surveillance of Scemblix Tablets (Resistant or Intolerant Chronic Myeloid Leukemia , CABL001A1401)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- AEs leading to interruption/discontinuation of the safety specifications
研究概览
简要总结
Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.
详细描述
The objective of this study is to collect data on the occurrence, severity, clinical courses of the safety specifications of asciminib, identify factors etc. involved in occurrence and assess its clinical safety inresistant/intolerant chronic myelogenous leukemia patients during an observational period of 48 weeks from the start of treatment with asciminib.
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
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients treated with asciminib in Japan.
排除标准
- 未提供
结局指标
主要结局
AEs leading to interruption/discontinuation of the safety specifications
时间窗: Up to 48 Weeks
For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), AEs leading to interruption/discontinuation will be collected
Number of patients with changes in relevant laboratory parameters for the safety specifications
时间窗: Up to 48 Weeks
For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), number of patients with changes in relevant laboratory parameters will be collected
Frequency of AEs/Treatment-related AEs by patient characteristic factor
时间窗: Up to 48 Weeks
Frequency of AEs/Treatment-related AEs by patient characteristic factor will be collected
Type, frequency, seriousness and severity of adverse event (AE)/treatment-related AE of the safety specifications
时间窗: Up to 48 Weeks
For the safety specifications (myelosuppression, infections, QT interval prolongation, pancreatitis, vascular occlusive events, photosensitivity), type, frequency AE, seriousness, severity of adverse event (AE)/treatment-related AE will be collected
次要结局
- Type, frequency, seriousness, severity of AEs/treatment-related AEs of the safety analysis set(Up to 48 Weeks)
- AEs leading to interruption/discontinuation in the safety analysis set(Up to 48 Weeks)
- Frequency of AEs/treatment-related AEs summarized by patient characteristic factor(Up to 48 Weeks)
- AEs leading to interruption/discontinuation in patients with special characteristics(Up to 48 Weeks)
- Type, frequency, seriousness, severity and outcome of AEs/treatment-related AEs by treatment line(Up to 48 Weeks)
- CHR rates by treatment line(Week 12, Week 24 and Week 48)
- AEs leading to interruption/discontinuation by treatment line(Up to 48 Weeks)
- Major molecular response (MMR) rates(Week 12, Week 24, Week 48)
- MMR rates by Week 48 in patients with special characteristics(Week 48)
- MR4.0 and MR4.5 rates by treatment line(Week 12, Week 24 and Week 48)
- Type, frequency, seriousness, severity of AEs/treatment-related AEs in patients with special characteristics(Up to 48 Weeks)
- Factors affecting occurrence of AEs by treatment line(Up to 48 Weeks)
- MR4.0 and MR4.5 rates(Week 12, Week 24 and Week 48)
- MMR rates by treatment line(Week 12, Week 24 and Week 48)
- CCyR rates by treatment line(Week 12, Week 24 and Week 48)
- MMR rates by Week 48 by patient characteristics factor(Up to 48 Weeks)
- Complete hematological response (CHR) rates(Week 12, Week 24 and Week 48)
- Rate of patients with BCR-ABL1 gene mutations(Up to 48 Weeks)
- Complete cytogenetic response (CCyR) rates(Week 12, Week 24 and Week 48)