A Retrospective Chart Review to Describe the Rate of Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L
研究概览
简要总结
This is a multi-center retrospective observational research study collecting data for participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) up to 6 years before start of data collection and who have completed/stopped docetaxel treatment at least 30 days prior to data collection. The primary goal of this study is to describe the percentage of participants with at least one neutropenic sepsis (NS) episode following initiation of treatment with single-agent docetaxel. Data will be collected until end of docetaxel treatment plus an additional 30 days to allow for presentation with toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosed with locally advanced or metastatic (stage Ill or IV) non-small cell lung cancer (NSCLC)
- •Relapsed disease following, or unable to tolerate, at least one line of prior chemotherapy
- •Initiated on single-agent docetaxel up to a maximum of 6 years prior to date of collection
- •Aged 18 years at date of first docetaxel dose
- •Completed or stopped treatment with docetaxel at least 30 days prior to date of data collection
排除标准
- •Receiving docetaxel in an interventional clinical trial
- •For whom no details of absolute neutrophil count are recorded
结局指标
主要结局
Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L
时间窗: Up to 6 years
次要结局
- Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia(Up to 6 years)
- Number of Episodes of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L(Up to 6 years)
- Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia(Up to 6 years)
- Number of Episodes of NS Associated with Death Attributable to NS(Up to 6 years)
- Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L(Up to 6 years)
- Percentage of Deaths Associated with the Occurrence of an NS Event(Up to 6 years)
- Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L(Up to 6 years)