Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.
研究概览
简要总结
Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.
详细描述
Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.
- Observe the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known, and whether there is any new adverse effects.Observe the incidence and the situation of adverse effects. Pay attention to the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction. Observe other safety issues related to drug using method, drug packaging method and drug quality.
[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day]
Secondary Outcome Measures: 2. Furtherly clarify the efficacy of palonosetron hydrochloride capsules, and the widely used population characteristics, and clinical using features of palonosetron hydrochloride capsules.
[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day]
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .
- •Elderly patients do not need to adjust the dosage of the drug.
- •Children using the drug and dose adjustment need to be evaluated by the doctor.
- •Pregnant and lactating patients using the drug need to be evaluated by the doctor.
- •5-HT3RA allergic patients do not recommend the use of this drug.
排除标准
- •All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .
研究组 & 干预措施
palonosetron palonosetron hydrochloride
A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)
干预措施: palonosetron hydrochloride capsules (Drug)
结局指标
主要结局
Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.
时间窗: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
1. Report the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known； 2. Report if there is any new adverse effects； 3. Report the incidence and the situation of the above adverse effects； 4. Report the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction； 5. Report other safety issues related to drug using method, drug packaging method and drug quality.
次要结局
- Report the efficacy of palonosetron hydrochloride capsules.(A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day)
- Report the widely used population characteristics.(A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day)
- Report the clinical using features of palonosetron hydrochloride capsules.(A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day)