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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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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