N/A
Completed N=1,454
FIRMAGON® Intensive Drug Monitoring
Source: ClinicalTrials.gov NCT05181800 ↗Enrolled (actual)
1,454
Serious AEs
4.3%
Results posted
Sep 2024
Primary outcomePrimary: Percentage of Participants With Any Adverse Events (AEs) — 95 Participants
Summary
To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy [ADT] treated with FIRMAGON®).
Study Design
This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Adverse Events (AEs) |
95 | — |
| PRIMARY Percentage of Participants With Serious AEs |
63 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer and in need of ADT
- Decision made to prescribe FIRMAGON® prior to enrollment
- Willingness and ability to provide written informed consent
- The participants are taking the marketed drug FIRMAGON®
Exclusion Criteria
- Not signed informed consent
- Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.
Data sourced from ClinicalTrials.gov (NCT05181800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.