NCT03148704

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

Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Cttq · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Palonosetron

Interventions

Type	Name	Description
DRUG	palonosetron hydrochloride capsules	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 .

Timeline

• Start date: 2017-03-08
• Primary completion: 2018-03-08
• Completion: 2018-06-08
• First posted: 2017-05-11
• Last updated: 2017-05-11

Locations

1 site across 1 country: China