A prognostic risk model for the occurrence of serious adverse events in breast cancer patients on Adriamycin-based chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- Occurrence of serious adverse events (SAE) in breast cancer patients on adriamycin based regimen.
研究概览
简要总结
The records of breast cancer patients undergoing Adriamycin-based therapy at the medical oncology dept will be assessed for the occurrence of serious adverse events (SAEs). The patient’s demographic and baseline data will be recorded by a pre-formed questionnaire. Predictor risk factors will be analysed for the occurrence of SAEs. All the potential risk factors for causing SAEs will be noted and considered for construction and validation of nomogram.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women above the age of 18 years diagnosed with breast cancer and receiving Adriamycin based therapy.
排除标准
- •Women suffering from any other malignancies or on any other anti-cancer drugs.
结局指标
主要结局
Occurrence of serious adverse events (SAE) in breast cancer patients on adriamycin based regimen.
时间窗: Risk factor data will be collected & assessed following Adriamycin-based regimen every day for 21 days at cycles 1,2,3,4,5 & 6.
次要结局
- To study the pattern of serious adverse events in breast cancer patients on adriamycin-based regimen.(Data on SAEs will be collected as per the predetermined data collection tool following Adriamycin-based regimen every day for 21 days at cycles 1,2,3,4,5 & 6.)
研究者
Dr R Siddhanth
Kasturba Medical College, MAHE, Manipal
