Trial Outcomes & Findings for A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (NCT NCT01234350)

NCT ID: NCT01234350

Last Updated: 2019-06-25

Results Overview

The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).

Recruitment status

COMPLETED

Target enrollment

1493 participants

Primary outcome timeframe

From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Results posted on

2019-06-25

Participant Flow

A total of 136 sites in 15 European countries (Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Switzerland, United Kingdom) recruited subjects to this observational study between January 2011 to April 2013, and the last subject completed the last visit in March 2018.

A total of 1,515 subjects were screened, of which 1,493 subjects were found to be eligible and exposed to treatment; 1,000 subjects in the FIRMAGON group and 493 subjects in the gonadotrophin releasing hormone (GnRH) agonist group.

Participant milestones

Participant milestones
Measure	FIRMAGON FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist Any GnRH agonist prescribed in accordance with the approved labels
Overall Study STARTED	1000	493
Overall Study COMPLETED	313	226
Overall Study NOT COMPLETED	687	267

Reasons for withdrawal

Reasons for withdrawal
Measure	FIRMAGON FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist Any GnRH agonist prescribed in accordance with the approved labels
Overall Study Adverse Event	277	92
Overall Study Withdrawal by Subject	61	36
Overall Study Lost to Follow-up	115	47
Overall Study Covers a diverse set of reasons	234	92

Baseline Characteristics

Number analyzed differs from the overall population as age was not recorded for some of the subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels	Total n=1493 Participants Total of all reporting groups
Age, Continuous Age	71.9 years STANDARD_DEVIATION 8.33 • n=999 Participants • Number analyzed differs from the overall population as age was not recorded for some of the subjects.	73.2 years STANDARD_DEVIATION 8.27 • n=493 Participants • Number analyzed differs from the overall population as age was not recorded for some of the subjects.	72.4 years STANDARD_DEVIATION 8.33 • n=1492 Participants • Number analyzed differs from the overall population as age was not recorded for some of the subjects.
Sex: Female, Male Female	0 Participants n=1000 Participants	0 Participants n=493 Participants	0 Participants n=1493 Participants
Sex: Female, Male Male	1000 Participants n=1000 Participants	493 Participants n=493 Participants	1493 Participants n=1493 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=780 Participants • Ethnicity was not recorded for some subjects.	5 Participants n=385 Participants • Ethnicity was not recorded for some subjects.	17 Participants n=1165 Participants • Ethnicity was not recorded for some subjects.
Ethnicity (NIH/OMB) Not Hispanic or Latino	697 Participants n=780 Participants • Ethnicity was not recorded for some subjects.	353 Participants n=385 Participants • Ethnicity was not recorded for some subjects.	1050 Participants n=1165 Participants • Ethnicity was not recorded for some subjects.
Ethnicity (NIH/OMB) Unknown or Not Reported	71 Participants n=780 Participants • Ethnicity was not recorded for some subjects.	27 Participants n=385 Participants • Ethnicity was not recorded for some subjects.	98 Participants n=1165 Participants • Ethnicity was not recorded for some subjects.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=780 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	1 Participants n=385 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	1 Participants n=1165 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.
Race (NIH/OMB) Asian	0 Participants n=780 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	2 Participants n=385 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	2 Participants n=1165 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=780 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	0 Participants n=385 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	0 Participants n=1165 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.
Race (NIH/OMB) Black or African American	9 Participants n=780 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	14 Participants n=385 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	23 Participants n=1165 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.
Race (NIH/OMB) White	745 Participants n=780 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	360 Participants n=385 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	1105 Participants n=1165 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.
Race (NIH/OMB) More than one race	0 Participants n=780 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	0 Participants n=385 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	0 Participants n=1165 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=780 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	8 Participants n=385 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.	34 Participants n=1165 Participants • Number analyzed differs from the overall population as race was not recorded for some of the subjects.
BMI (kg/m^2)	27 kg/m^2 STANDARD_DEVIATION 3.91 • n=786 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects.	26.8 kg/m^2 STANDARD_DEVIATION 3.82 • n=406 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects.	26.9 kg/m^2 STANDARD_DEVIATION 3.88 • n=1192 Participants • Number analyzed differs from the overall population as baseline body mass index (BMI) was not calculated for some of the subjects.

PRIMARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Population: The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).

The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events	3.8 Events per 100 PYE	4.5 Events per 100 PYE

PRIMARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Incidence Rate of AESI: Decreased Bone Density Osteoporosis or Osteopenia	1.1 Events per 100 PYE	1.4 Events per 100 PYE
Incidence Rate of AESI: Decreased Bone Density Bone fracture	0.3 Events per 100 PYE	0.1 Events per 100 PYE

PRIMARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE. Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) Glucose intolerance	15.3 Events per 100 PYE	13.2 Events per 100 PYE
Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) T2DM	1.8 Events per 100 PYE	0.7 Events per 100 PYE

PRIMARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change from baseline in hepatic enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase \[ALP\]) are presented.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Change in Hepatic Enzymes ALP (Visit 5, Month 12)	0.0 IU/L Interval -1029.0 to 614.0	0.1 IU/L Interval -661.0 to 184.0
Change in Hepatic Enzymes ALP (Visit 6, Month 15)	0.1 IU/L Interval -1027.0 to 957.0	0.0 IU/L Interval -225.0 to 370.0
Change in Hepatic Enzymes ALP (Visit 7, Month 18)	0.1 IU/L Interval -1031.0 to 475.0	0.1 IU/L Interval -217.0 to 889.0
Change in Hepatic Enzymes ALP (Visit 8, Month 21)	0.0 IU/L Interval -539.0 to 777.0	0.0 IU/L Interval -197.0 to 364.0
Change in Hepatic Enzymes ALP (Visit 9, Month 24)	0.1 IU/L Interval -756.0 to 307.0	0.1 IU/L Interval -228.0 to 446.0
Change in Hepatic Enzymes ALP (Visit 10, Month 30)	0.0 IU/L Interval -540.0 to 300.0	0.1 IU/L Interval -211.0 to 169.0
Change in Hepatic Enzymes ALP (Visit 11, Month 36)	-0.3 IU/L Interval -764.0 to 748.0	0.1 IU/L Interval -185.0 to 386.0
Change in Hepatic Enzymes ALP (Visit 12, Month 42)	-0.1 IU/L Interval -773.0 to 1238.0	0.2 IU/L Interval -182.0 to 235.0
Change in Hepatic Enzymes ALP (Visit 13, Month 48)	-0.1 IU/L Interval -785.0 to 657.0	0.2 IU/L Interval -204.0 to 114.0
Change in Hepatic Enzymes ALP (Visit 14, Month 54)	-0.2 IU/L Interval -779.0 to 79.0	0.3 IU/L Interval -197.0 to 104.0
Change in Hepatic Enzymes ALP (Visit 15 [EOT], Month 60)	-5.0 IU/L Interval -756.0 to 164.0	0.2 IU/L Interval -157.0 to 89.0
Change in Hepatic Enzymes AST (Visit 2, Month 6)	0.1 IU/L Interval -72.0 to 64.0	0.0 IU/L Interval -82.0 to 49.0
Change in Hepatic Enzymes AST (Visit 3, Month 9)	0.1 IU/L Interval -73.0 to 79.0	0.0 IU/L Interval -74.0 to 37.0
Change in Hepatic Enzymes AST (Visit 4, Month 12)	0.0 IU/L Interval -68.0 to 69.0	0.1 IU/L Interval -41.0 to 60.0
Change in Hepatic Enzymes AST (Visit 5, Month 15)	0.0 IU/L Interval -72.0 to 44.0	0.1 IU/L Interval -77.0 to 108.0
Change in Hepatic Enzymes AST (Visit 6, Month 15)	0.0 IU/L Interval -73.0 to 194.0	0.1 IU/L Interval -78.0 to 54.0
Change in Hepatic Enzymes AST (Visit 7, Month 18)	0.0 IU/L Interval -72.0 to 108.0	0.1 IU/L Interval -37.0 to 60.0
Change in Hepatic Enzymes AST (Visit 8, Month 21)	0.0 IU/L Interval -73.0 to 25.0	0.1 IU/L Interval -45.0 to 73.0
Change in Hepatic Enzymes AST (Visit 9, Month 24)	0.0 IU/L Interval -75.0 to 68.0	0.0 IU/L Interval -43.0 to 32.0
Change in Hepatic Enzymes AST (Visit 10, Month 30)	0.0 IU/L Interval -73.0 to 28.0	0.0 IU/L Interval -46.0 to 665.0
Change in Hepatic Enzymes AST (Visit 11, Month 36)	0.0 IU/L Interval -72.0 to 57.0	0.1 IU/L Interval -43.0 to 43.0
Change in Hepatic Enzymes AST (Visit 12, Month 40)	0.0 IU/L Interval -70.0 to 21.0	0.0 IU/L Interval -53.0 to 30.0
Change in Hepatic Enzymes AST (Visit 13, Month 48)	-0.1 IU/L Interval -70.0 to 167.0	0.0 IU/L Interval -52.0 to 18.0
Change in Hepatic Enzymes AST (Visit 14, Month 54)	-0.3 IU/L Interval -68.0 to 34.0	0.0 IU/L Interval -48.0 to 29.0
Change in Hepatic Enzymes AST (Visit 15 [EOT], Month 60)	0.0 IU/L Interval -35.0 to 22.0	0.0 IU/L Interval -42.0 to 15.0
Change in Hepatic Enzymes ALT (Visit 2, Month 3)	0.1 IU/L Interval -70.0 to 63.0	0.1 IU/L Interval -19.0 to 82.0
Change in Hepatic Enzymes ALT (Visit 3, Month 6)	0.1 IU/L Interval -65.0 to 174.0	0.1 IU/L Interval -41.0 to 125.0
Change in Hepatic Enzymes ALT (Visit 4, Month 9)	0.0 IU/L Interval -66.0 to 55.0	0.0 IU/L Interval -22.0 to 54.0
Change in Hepatic Enzymes ALT (Visit 5, Month 12)	0.0 IU/L Interval -63.0 to 57.0	0.0 IU/L Interval -38.0 to 49.0
Change in Hepatic Enzymes ALT (Visit 6, Month 15)	-0.1 IU/L Interval -69.0 to 30.0	0.0 IU/L Interval -44.0 to 37.0
Change in Hepatic Enzymes ALT (Visit 7, Month 18)	-0.1 IU/L Interval -68.0 to 41.0	0.1 IU/L Interval -26.0 to 77.0
Change in Hepatic Enzymes ALT (Visit 8, Month 21)	-0.1 IU/L Interval -70.0 to 204.0	0.1 IU/L Interval -25.0 to 49.0
Change in Hepatic Enzymes ALT (Visit 9, Month 24)	-0.1 IU/L Interval -65.0 to 332.0	0.0 IU/L Interval -24.0 to 20.0
Change in Hepatic Enzymes ALT (Visit 10, Month 30)	-0.1 IU/L Interval -80.0 to 28.0	0.0 IU/L Interval -23.0 to 26.0
Change in Hepatic Enzymes ALT (Visit 11, Month 36)	-0.1 IU/L Interval -50.0 to 317.0	0.0 IU/L Interval -16.0 to 90.0
Change in Hepatic Enzymes ALT (Visit 12, Month 42)	-0.1 IU/L Interval -35.0 to 31.0	0.0 IU/L Interval -44.0 to 33.0
Change in Hepatic Enzymes ALT (Visit 13, Month 48)	-1.0 IU/L Interval -36.0 to 97.0	0.0 IU/L Interval -45.0 to 28.0
Change in Hepatic Enzymes ALT (Visit 14, Month 54)	-1.0 IU/L Interval -53.0 to 32.0	-0.1 IU/L Interval -32.0 to 13.0
Change in Hepatic Enzymes ALT (Visit 15, end of trial [EOT], Month 60)	-0.2 IU/L Interval -30.0 to 33.0	0.0 IU/L Interval -16.0 to 16.0
Change in Hepatic Enzymes ALP (Visit 2, Month 3)	0.0 IU/L Interval -661.0 to 738.0	-0.1 IU/L Interval -632.0 to 240.0
Change in Hepatic Enzymes ALP (Visit 3, Month 6)	0.0 IU/L Interval -990.0 to 979.0	0.0 IU/L Interval -649.0 to 135.0
Change in Hepatic Enzymes ALP (Visit 4, Month 9)	0.0 IU/L Interval -1009.0 to 1024.0	0.1 IU/L Interval -658.0 to 225.0

PRIMARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change from baseline in hepatic enzyme level (bilirubin) is presented.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Change in Hepatic Enzymes Visit 2, Month 3	-1.0 umol/L Interval -169.0 to 97.0	-1.0 umol/L Interval -108.0 to 15.0
Change in Hepatic Enzymes Visit 3, Month 6	-1.0 umol/L Interval -234.0 to 216.0	-2.0 umol/L Interval -16.0 to 136.0
Change in Hepatic Enzymes Visit 4, Month 9	-0.9 umol/L Interval -233.0 to 38.0	-0.6 umol/L Interval -18.0 to 93.0
Change in Hepatic Enzymes Visit 5, Month 12	-1.3 umol/L Interval -98.0 to 113.0	-0.6 umol/L Interval -285.0 to 13.0
Change in Hepatic Enzymes Visit 6, Month 15	-0.9 umol/L Interval -22.0 to 166.0	-0.7 umol/L Interval -23.0 to 245.0
Change in Hepatic Enzymes Visit 7, Month 18	-1.2 umol/L Interval -99.0 to 111.0	-0.4 umol/L Interval -28.0 to 65.0
Change in Hepatic Enzymes Visit 8, Month 21	-1.5 umol/L Interval -200.0 to 145.0	-1.1 umol/L Interval -287.0 to 12.0
Change in Hepatic Enzymes Visit 9, Month 24	-0.8 umol/L Interval -196.0 to 141.0	-1.5 umol/L Interval -113.0 to 15.0
Change in Hepatic Enzymes Visit 10, Month 30	-1.4 umol/L Interval -199.0 to 14.0	-0.4 umol/L Interval -282.0 to 126.0
Change in Hepatic Enzymes Visit 11, Month 36	-1.8 umol/L Interval -200.0 to 137.0	-3.2 umol/L Interval -282.0 to 11.0
Change in Hepatic Enzymes Visit 12, Month 40	-1.6 umol/L Interval -196.0 to 129.0	-1.7 umol/L Interval -112.0 to 10.0
Change in Hepatic Enzymes Visit 13, Month 48	-0.9 umol/L Interval -192.0 to 58.0	-1.9 umol/L Interval -286.0 to 125.0
Change in Hepatic Enzymes Visit 14, Month 54	-1.3 umol/L Interval -98.0 to 145.0	-1.9 umol/L Interval -286.0 to 83.0
Change in Hepatic Enzymes Visit 15 (EOT), Month 60	-1.9 umol/L Interval -101.0 to 14.0	-0.8 umol/L Interval -286.0 to 13.0

PRIMARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change from baseline in serum glucose are presented.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Change in Serum Glucose Visit 2, Month 3	0.0 mmol/L Interval -5.0 to 9.0	0.0 mmol/L Interval -5.0 to 6.0
Change in Serum Glucose Visit 3, Month 6	0.0 mmol/L Interval -6.0 to 4.0	0.0 mmol/L Interval -11.0 to 7.0
Change in Serum Glucose Visit 4, Month 9	0.1 mmol/L Interval -7.0 to 14.0	0.1 mmol/L Interval -7.0 to 5.0
Change in Serum Glucose Visit 5, Month 12	0.0 mmol/L Interval -8.0 to 6.0	0.0 mmol/L Interval -14.0 to 9.0
Change in Serum Glucose Visit 6, Month 15	0.0 mmol/L Interval -6.0 to 5.0	0.2 mmol/L Interval -8.0 to 6.0
Change in Serum Glucose Visit 7, Month 18	0.0 mmol/L Interval -8.0 to 3.0	0.2 mmol/L Interval -13.0 to 6.0
Change in Serum Glucose Visit 8, Month 21	0.0 mmol/L Interval -9.0 to 5.0	0.1 mmol/L Interval -12.0 to 6.0
Change in Serum Glucose Visit 9, Month 24	0.0 mmol/L Interval -6.0 to 4.0	-0.2 mmol/L Interval -4.0 to 6.0
Change in Serum Glucose Visit 10, Month 30	0.0 mmol/L Interval -6.0 to 4.0	0.0 mmol/L Interval -8.0 to 7.0
Change in Serum Glucose Visit 11, Month 36	0.0 mmol/L Interval -6.0 to 4.0	0.2 mmol/L Interval -5.0 to 9.0
Change in Serum Glucose Visit 12, Month 42	0.1 mmol/L Interval -6.0 to 4.0	-0.1 mmol/L Interval -4.0 to 2.0
Change in Serum Glucose Visit 13, Month 48	0.2 mmol/L Interval -3.0 to 8.0	0.0 mmol/L Interval -6.0 to 6.0
Change in Serum Glucose Visit 14, Month 54	0.0 mmol/L Interval -5.0 to 3.0	0.1 mmol/L Interval -10.0 to 9.0
Change in Serum Glucose Visit 15 (EOT), Month 60	0.1 mmol/L Interval -1.0 to 9.0	0.2 mmol/L Interval -10.0 to 3.0

SECONDARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

An ADR was defined as an AE assessed by investigator as possibly/probably related to the investigational product. Any new potentially unrecognized ADRs were presented.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Number and Classification of New Adverse Drug Reactions (ADRs)	0 New ADR	0 New ADR

SECONDARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change in prostate specific antigen (PSA) is presented.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 2, Month 3	-20.1 ng/mL Interval -788.0 to 297.0	-10.7 ng/mL Interval -438.0 to 160.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 3, Month 6	-19.1 ng/mL Interval -789.0 to 161.0	-11.4 ng/mL Interval -466.0 to 399.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 4, Month 9	-17.0 ng/mL Interval -788.0 to 583.0	-11.5 ng/mL Interval -477.0 to 260.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 5, Month 12	-17.5 ng/mL Interval -787.0 to 578.0	-12.9 ng/mL Interval -465.0 to 311.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 6, Month 15	-15.8 ng/mL Interval -783.0 to 493.0	-11.0 ng/mL Interval -472.0 to 648.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 7, Month 18	-16.0 ng/mL Interval -770.0 to 665.0	-11.3 ng/mL Interval -477.0 to 790.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 8, Month 21	-14.4 ng/mL Interval -770.0 to 201.0	-11.0 ng/mL Interval -485.0 to 567.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 9, Month 24	-14.0 ng/mL Interval -770.0 to 325.0	-11.9 ng/mL Interval -442.0 to 297.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 10, Month 30	-14.6 ng/mL Interval -770.0 to 692.0	-11.7 ng/mL Interval -488.0 to 394.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 11, Month 36	-15.4 ng/mL Interval -770.0 to 410.0	-11.4 ng/mL Interval -485.0 to 590.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 12, Month 42	-16.7 ng/mL Interval -770.0 to 548.0	-10.5 ng/mL Interval -486.0 to 498.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 13, Month 48	-15.1 ng/mL Interval -770.0 to 487.0	-9.5 ng/mL Interval -484.0 to 248.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 14, Month 54	-13.0 ng/mL Interval -770.0 to 204.0	-8.9 ng/mL Interval -482.0 to 98.0
Long Term Evaluation of Clinical Evolution of Prostate Cancer Visit 15 (EOT), Month 69	-14.7 ng/mL Interval -770.0 to 405.0	-9.0 ng/mL Interval -407.0 to 39.0

SECONDARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Change from baseline in testosterone levels are presented.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
Changes in Testosterone Levels Visit 2, Month 3	-3.6 ng/mL Interval -38.0 to 33.0	-3.0 ng/mL Interval -10.0 to 30.0
Changes in Testosterone Levels Visit 3, Month 6	-3.8 ng/mL Interval -38.0 to 17.0	-3.3 ng/mL Interval -19.0 to 0.0
Changes in Testosterone Levels Visit 4, Month 9	-3.6 ng/mL Interval -38.0 to 53.0	-3.190 ng/mL Interval -10.16 to -0.03
Changes in Testosterone Levels Visit 5, Month 12	-3.6 ng/mL Interval -38.0 to 9.0	-3.236 ng/mL Interval -9.79 to 8.82
Changes in Testosterone Levels Visit 6, Month 15	-3.5 ng/mL Interval -38.0 to 10.0	-3.146 ng/mL Interval -10.16 to 0.1
Changes in Testosterone Levels Visit 7, Month 18	-3.6 ng/mL Interval -22.0 to 35.0	-3.127 ng/mL Interval -9.79 to 5.34
Changes in Testosterone Levels Visit 8, Month 21	-3.3 ng/mL Interval -38.0 to 22.0	-3.175 ng/mL Interval -9.8 to -0.03
Changes in Testosterone Levels Visit 9, Month 24	-3.5 ng/mL Interval -37.0 to 19.0	-3.041 ng/mL Interval -9.8 to 1.14
Changes in Testosterone Levels Visit 10, Month 30	-3.5 ng/mL Interval -22.0 to 2.0	-2.847 ng/mL Interval -9.78 to 3.57
Changes in Testosterone Levels Visit 11, Month 36	-3.7 ng/mL Interval -22.0 to 2.0	-2.977 ng/mL Interval -9.78 to 3.85
Changes in Testosterone Levels Visit 12, Month 42	-3.7 ng/mL Interval -22.0 to 2.0	-2.835 ng/mL Interval -9.65 to 0.13
Changes in Testosterone Levels Visit 13, Month 48	-3.930 ng/mL Interval -22.0 to 10.78	-2.6 ng/mL Interval -10.0 to 4.0
Changes in Testosterone Levels Visit 14, Month 54	-3.380 ng/mL Interval -22.23 to 7.35	-2.463 ng/mL Interval -9.61 to 3.6
Changes in Testosterone Levels Visit 15 (EOT), Month 60	-3.870 ng/mL Interval -22.23 to 1.61	-2.2 ng/mL Interval -8.0 to 3.0

SECONDARY outcome

Timeframe: From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

A summary of IRs of all-cause mortality is presented.

Outcome measures

Outcome measures
Measure	FIRMAGON n=1000 Participants FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 Participants Any GnRH agonist prescribed in accordance with the approved labels
All-cause of Mortality	6.5 Events per 100 PYE	5.1 Events per 100 PYE

Adverse Events

FIRMAGON

Serious events: 236 serious events

Other events: 294 other events

Deaths: 141 deaths

GnRH Agonist

Serious events: 144 serious events

Other events: 110 other events

Deaths: 72 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FIRMAGON n=1000 participants at risk FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label	GnRH Agonist n=493 participants at risk Any GnRH agonist prescribed in accordance with the approved labels
General disorders Injection site pain	10.0% 100/1000 • Number of events 226 • From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product. The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).	0.41% 2/493 • Number of events 2 • From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product. The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).
Investigations Prostatic specific antigen increased	8.0% 80/1000 • Number of events 90 • From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product. The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).	5.3% 26/493 • Number of events 29 • From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product. The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).
Vascular disorders Hot flush	16.6% 166/1000 • Number of events 172 • From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product. The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).	17.8% 88/493 • Number of events 92 • From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product. The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

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