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

CTTQ

Status: Unknown

Conditions: Palonosetron

Treatments: Drug: palonosetron hydrochloride capsules

Study type: Observational

Funder types: Industry

Identifiers

NCT03148704

Ruo Shan new drug monitoring

Details and patient eligibility

About

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

Full 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]

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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®) .

Trial design

3,000 participants in 1 patient group

palonosetron palonosetron hydrochloride

Description:

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

Treatment:

Drug: palonosetron hydrochloride capsules