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

NCT03148704 | Unknown

• 1 other identifier: Ruo Shan new drug monitoring
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Palonosetron

Outcome Measures

Primary Outcomes (1)

• Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.

  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.

  A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day

Secondary Outcomes (3)

• 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

Study Arms (1)

palonosetron palonosetron hydrochloride

A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)

Drug: palonosetron hydrochloride capsules

Interventions

palonosetron hydrochloride capsules DRUG

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 .

Also known as: Ruo Shan®

palonosetron palonosetron hydrochloride

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)

You may qualify if:

• 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.
• HT3RA allergic patients do not recommend the use of this drug.

You may not qualify if:

• All situations that the doctor think it is not suitable to use palonosetron hydrochloride capsules(Ruo Shan®) .

Sponsors & Collaborators

• Cttq: lead

Study Sites (1)

The 81st Hostital of PLA

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

Palonosetron

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• qin shu kui

  The 81st Hostital of PLA

  STUDY CHAIR

Central Study Contacts

zheng bo

CONTACT

18136659876; jtuu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: March 8, 2017
• Primary Completion: March 8, 2018
• Study Completion: June 8, 2018
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)