Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)

Study Overview
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Brief Summary
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Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.

Detailed Description
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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: 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]

Official Title
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Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules

Conditions
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Palonosetron

Intervention / Treatment
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* Drug: palonosetron hydrochloride capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| palonosetron palonosetron hydrochloride<br>A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®) | Drug: palonosetron hydrochloride capsules<br>* Collect all the patients' safty and efficacy data as long as they use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .<br>* Other names: Ruo Shan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using. | Report the adverse effects of palonosetron hydrochloride capsules(Ruo Shan®) that we already known； Report if there is any new adverse effects； Report the incidence and the situation of the above adverse effects； Report the adverse effects in special groups, like pregnant women, children, elderly patients, and patients with liver and kidney dysfunction； Report other safety issues related to drug using method, drug packaging method and drug quality. | A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report the efficacy of palonosetron hydrochloride capsules. | Report the control condition of nausea and vomiting. | A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day | 
| Report the widely used population characteristics. | Report the patients' disease, age, treatment, and chemotherapy drugs. | 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. | Report the Using does,time,and frequency of palonosetron hydrochloride capsules,and the concomitant drugs . | A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day |