FIRMAGON® Intensive Drug Monitoring

Ferring Pharmaceuticals1,454 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,454

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Participants With Any Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with treatment.

Time frame: From the signing of the informed consent up to the end-of-trial (12 months)

Percentage of Participants With Serious AEs

An SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event or reaction.