Trial Outcomes & Findings for FIRMAGON® Intensive Drug Monitoring (NCT NCT05181800)
NCT ID: NCT05181800
Last Updated: 2024-09-27
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1454 participants
Primary outcome timeframe
From the signing of the informed consent up to the end-of-trial (12 months)
Results posted on
2024-09-27
Participant Flow
The study was performed at 145 investigational sites in China between August 2019 and December 2022.
In total, 1454 participants were screened and all the participants enrolled in the study
Participant milestones
| Measure |
FIRMAGON Cohort
FIRMAGON Cohort: Non-interventional
|
|---|---|
|
Overall Study
STARTED
|
1454
|
|
Overall Study
COMPLETED
|
1454
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FIRMAGON® Intensive Drug Monitoring
Baseline characteristics by cohort
| Measure |
FIRMAGON Cohort
n=1454 Participants
FIRMAGON Cohort: Non-interventional
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
300 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1154 Participants
n=5 Participants
|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1454 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1454 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
1454 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the signing of the informed consent up to the end-of-trial (12 months)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.
Outcome measures
| Measure |
FIRMAGON Cohort
n=1454 Participants
FIRMAGON Cohort: Non-interventional
|
|---|---|
|
Percentage of Participants With Any Adverse Events (AEs)
|
95 Participants
|
PRIMARY outcome
Timeframe: From the signing of the informed consent up to the end-of-trial (12 months)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.
Outcome measures
| Measure |
FIRMAGON Cohort
n=1454 Participants
FIRMAGON Cohort: Non-interventional
|
|---|---|
|
Percentage of Participants With Serious AEs
|
63 Participants
|
Adverse Events
FIRMAGON Cohort
Serious events: 63 serious events
Other events: 95 other events
Deaths: 55 deaths
Serious adverse events
| Measure |
FIRMAGON Cohort
n=1454 participants at risk
FIRMAGON Cohort: Non-interventional
|
|---|---|
|
General disorders
Pyrexia
|
0.21%
3/1454 • Number of events 3 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Injection site reactions
|
0.14%
2/1454 • Number of events 4 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Feeling cold
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Asthenia
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.14%
2/1454 • Number of events 2 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Somnolence
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Seizure
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Loss of consciousness
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.34%
5/1454 • Number of events 5 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Vascular disorders
Shock
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Infections and infestations
Coronavirus infection
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Investigations
Weight decreased
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Death (unknown cause)
|
3.2%
46/1454 • Number of events 46 • From the signing of the informed consent up to the end-of-trial (12 months)
|
Other adverse events
| Measure |
FIRMAGON Cohort
n=1454 participants at risk
FIRMAGON Cohort: Non-interventional
|
|---|---|
|
General disorders
Pyrexia
|
1.6%
23/1454 • Number of events 30 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Injection site reactions
|
1.2%
17/1454 • Number of events 41 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Asthenia
|
0.34%
5/1454 • Number of events 5 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Chills
|
0.21%
3/1454 • Number of events 4 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Drug ineffective
|
0.14%
2/1454 • Number of events 2 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Feeling cold
|
0.14%
2/1454 • Number of events 2 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Feeling hot
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Malaise
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Pain
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
General disorders
Generalised oedema
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Dizziness
|
0.28%
4/1454 • Number of events 4 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Headache
|
0.14%
2/1454 • Number of events 2 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.14%
2/1454 • Number of events 2 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Somnolence
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Seizure
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Ageusia
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Nervous system disorders
Loss of consciousness
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
3/1454 • Number of events 3 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Gastrointestinal disorders
Flatulence
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.34%
5/1454 • Number of events 5 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.21%
3/1454 • Number of events 3 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Metabolism and nutrition disorders
Marasmus
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
2/1454 • Number of events 2 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Renal and urinary disorders
Urine abnormality
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Vascular disorders
Shock
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Psychiatric disorders
Poor quality sleep
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Immune system disorders
Hypersensitivity
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Infections and infestations
Coronavirus infection
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Investigations
Weight decreased
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.07%
1/1454 • Number of events 1 • From the signing of the informed consent up to the end-of-trial (12 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER