Adverse Drug Reaction monitoring in oncology patients receiving chemotherapy for generating safety indicators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1.The incidence rate for ADRs in the study population will be identified.
研究概览
简要总结
A prospective, cross-sectional study will be conducted at the Department of Oncology (Medical Oncology, Surgical Oncology, Palliative Medicine, Pediatric and Radiotherapy) of Kasturba Hospital, Manipal. Patients will be identified in the oncology wards based on inclusion criteria. Throughout the duration of the study, consent will be obtained from the patients and confidentiality will be maintained. Patient case files will be assessed for identification of ADRs, and data will be collected according to the data collection form. Causality assessment of the ADRs will be done and their outcome will be studied. Indicators will be identified based on the ADRs found. Data analysis and interpretation will be done using Jamovi software.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients under chemotherapeutic regimen, developed ADR and willing to participate.
排除标准
- •Outpatients Not willing to participate in the study.
结局指标
主要结局
1.The incidence rate for ADRs in the study population will be identified.
时间窗: Just 1 time point after the participant has developed adverse drug reaction
2. The causality of ADRs will be identified.
时间窗: Just 1 time point after the participant has developed adverse drug reaction
次要结局
- A list of indicators for ADRs will be identified(At the end of the study)
研究者
Sriya Lingamagunta
Manipal College of Pharmaceutical Sciences