CTRI/2024/03/064191尚未招募不适用
Adverse Drug Reaction Monitoring In Patients Undergoing Chemotherapy At A State-Level Cancer Institute
Not Available1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To detect and assess the adverse drug reactions in patients undergoing cancer chemotherapy using WHO-UMC scale for causality.
研究概览
简要总结
This study title is ADVERSE DRUG REACTION MONITORING IN PATIENTS UNDERGOING CHEMOTHERAPY AT A STATE LEVEL CANCER INSTITUTE
This study is designed to detect and evaluate the adverse drug reactions manifesting in patients receiving chemotherapy.
It will be an intensive, focused approach to adverse drug reactin reporting.
The study protocol has already been approved by Institutional Scientific and Ethics Committee, Government Medical College, Amritsar.
The study recruitment will start on 24/03/2024.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients of all age groups receiving cancer chemotherapy and developing at least one ADR.
- •Patients willing to join the study after giving a written informed consent.
排除标准
- •Patients receiving concurrent radiotherapy along with chemotherapy.
- •Patient not willing to give consent for the study.
结局指标
主要结局
To detect and assess the adverse drug reactions in patients undergoing cancer chemotherapy using WHO-UMC scale for causality.
时间窗: One time enquiry
次要结局
- To assess the severity of ADRs using the Modified Hartwig and Siegel Scale(One time enquiry)
- To assess the preventability of ADRs using Modified Schumock and Thornton scale(One time Enquiry)
研究者
Dr. Dixit Goyal
Government Medical College, Amritsar
研究点 (1)
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