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

Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03148704
Enrollment
3000
Registered
2017-05-11
Start date
2017-03-08
Completion date
2018-06-08
Last updated
2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palonosetron

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. \[Time Frame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day\]

Interventions

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 .

Sponsors

Cttq
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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®) .

Design outcomes

Primary

MeasureTime frameDescription
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 day1. 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

MeasureTime frameDescription
Report the efficacy of palonosetron hydrochloride capsules.A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth dayReport 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 dayReport 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 dayReport the Using does,time,and frequency of palonosetron hydrochloride capsules,and the concomitant drugs .

Countries

China

Contacts

Primary Contactzheng bo
jtuu@163.com18136659876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026