Clinical trial NCT03148704: Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®)
Official title: Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Palonosetron
Lead sponsor: Cttq
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A continuous sequence of patients using palonosetron palonosetron hydrochloride capsules(Ruo Shan®)

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.

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

Eligibility criteria: 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®) .

Primary outcomes:
measure: Report the palonosetron hydrochloride capsules'(Ruo Shan®) safety information in the real world using.
timeFrame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Secondary outcomes:
measure: Report the efficacy of palonosetron hydrochloride capsules.
timeFrame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
measure: Report the widely used population characteristics.
timeFrame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
measure: Report the clinical using features of palonosetron hydrochloride capsules.
timeFrame: A period between the first day of using Palonosetron Hydrochloride Capsules (Ruo Shan®) to the fifth day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The 81st Hostital of PLA
state: Jiangsu
Study officials:
affiliation: The 81st Hostital of PLA
name: qin shu kui
role: STUDY_CHAIR
References: