Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)
- Conditions
- Palonosetron
- Interventions
- Registration Number
- NCT03148704
- Lead Sponsor
- Cttq
- Brief Summary
Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.
- Detailed Description
Observe palonosetron hydrochloride capsules'(Ruo Shan®) safety and efficacy information in the real world using.
1. 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.
\[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day\]
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
- 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.
- All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description palonosetron palonosetron hydrochloride palonosetron hydrochloride capsules A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)
- Primary Outcome Measures
Name Time Method Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using. 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.
- Secondary Outcome Measures
Name Time Method 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 control condition of nausea and vomiting.
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 patients' disease, age, treatment, and chemotherapy drugs.
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 Report the Using does,time,and frequency of palonosetron hydrochloride capsules,and the concomitant drugs .
Trial Locations
- Locations (1)
The 81st Hostital of PLA
🇨🇳Nanjing, Jiangsu, China