An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Locally Advanced, Metastatic or Locally Recurrent Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumor Histology After First Line Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 11
- 主要终点
- Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients
研究概览
简要总结
This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017). The objective is to look at the safety of nintedanib in the real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after first line chemotherapy who have initiated or will initiate nintedanib & docetaxel according to the package insert after the commercial availability of drug in India (23rd January 2017).
- •Patients in whom it is possible to obtain voluntary informed consent from either the patient or patient's legally authorised representative (applicable for Group B and C patients).
- •Patients in whom data collection is possible from the medical records (applicable for Group A and B patients).
- •Further inclusion criteria apply.
排除标准
- •Patients who were previously treated with nintedanib.
- •Patients who are positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements
- •Patients who are participating in a clinical trial.
- •Further exclusion criteria apply.
结局指标
主要结局
Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients
时间窗: From first drug administration until 28 days after the last drug administration, up to 586 days.
Incidence of all Adverse drug reactions (ADRs) in nintedanib and docetaxel treated patients. An Adverse Event (AE) was considered as an Adverse drug reaction (ADR) if either the physician who reported the AE or the sponsor assessed its causal relationship as 'related'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as \[100 pt -yrs\].
Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients
时间窗: From first drug administration until 28 days after the last drug administration, up to 586 days.
Incidence rate of all Serious Adverse Events (SAEs) in nintedanib and docetaxel treated patients. All Adverse Events (AEs) that occurred between the first intake of nintedanib plus docetaxel and within 28 days (inclusive) after the last intake were considered 'treatment emergent'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as \[100 pt -yrs\].
次要结局
- Percentage of Patients Who Required Nintedanib Dose Reductions(From first drug administration until 28 days after the last drug administration, up to 586 days.)
- Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events(From first drug administration until last drug administration, up to 558 days.)