Patient Safety
Conditions
Brief summary
A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients
Detailed description
This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).
Interventions
DRUGElunate®
The recommended dose is 5 mg once daily (1 capsule, each capsule contains 5 mg of fruquintinib); three weeks of continuous drug administration followed by one week of drug free period (4 weeks as one treatment cycle).
Sponsors
Hutchmed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week; * Provision of informed consent by the patient.
Exclusion criteria
• Unsuitable for the study according to investigator's judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs | from the first administration of fruquintinib up to 6 months | % of patients with AEs according to CTCAE 4.03 |
| Incidence of ADRs | from the first administration of fruquintinib up to 6 months | % of patients with ADRs according to CTCAE 4.03 |
| Incidence of SAEs | from the first administration of fruquintinib up to 6 months | % of patients with SAEs according to CTC AE 4.03 |
| Incidence of AESI | from the first administration of fruquintinib up to 6 months | % of patients with AESI according to CTC AE 4.03 |
Countries
China
Outcome results
None listed