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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021434-55 | EudraCT Number |
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Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.
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A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).
In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).
The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 240 mg/480 mg | Experimental |
| |
| Goserelin acetate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin | PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS. | From baseline to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin | PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure. | From baseline to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Aurora | Colorado | United States | |||
| The Urology Center of Colorado |
Participants entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
All participants who completed the main CS35 trial after initiation of the CS35A extension trial were eligible to enrol into CS35A.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 240 mg/480 mg | Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
|
| Goserelin acetate | Drug | The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months. |
|
|
| Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin | PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure. | From baseline to 3 years |
| Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin | Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape. | From baseline to 3 years |
| Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin | Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer. | From baseline to 3 years |
| Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin | The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death. | From baseline to 3 years |
| Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin | Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed. | Baseline and after 1, 6, 12, 19, and 22 months |
| Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin | Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed. | Baseline and after 1, 6, 12, 19, and 22 months |
| Denver |
| Colorado |
| United States |
| Urology Associates of Dover, PA | Dover | Delaware | United States |
| South Florida Medical Research | Aventura | Florida | United States |
| Urology Group of New Mexico, PC | Albuquerque | New Mexico | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | United States |
| Urology San Antonio Research, Pa | San Antonio | Texas | United States |
| Seattle Urology Research Center | Burien | Washington | United States |
| AZ Groeninge - Campus Sint-Maarten | Kortrijk | Belgium |
| Jonathan Giddens Medicine Professional Corporation | Brampton | Ontario | Canada |
| Southern Interior Medical Research Inc. | Kelowna | Canada |
| Mor Urology, Inc. | Newmarket | Canada |
| Investigational site | Scarborough | Canada |
| Investigational site | Toronto | Canada |
| Urocentrum Brno | Brno | Czechia |
| Nemocnice Jindrichuv Hradec, a.s. | Jindřichův Hradec | Czechia |
| Kromerizska nemocnice a.s. | KroměřÞ | Czechia |
| Fakultni nemocnice v Motole, Praha 5 | Prague | Czechia |
| Vseobecna fakultni nemocnice v Praze, Praha 2 | Prague | Czechia |
| Krajska nemocnice T. Bati a.s. | ZlÃn | Czechia |
| ODL Terveys Oy | Oulu | Finland |
| Pohjois-Karjalan keskussairaala | Tampere | Finland |
| Tampereen yliopistollinen sairaala | Tampere | Finland |
| Gemeinschaftspraxis Rudolph & Wörner | Kirchheim | Germany |
| Urologische Studienpraxis | Nürtingen | Germany |
| Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház | Budapest | Hungary |
| Fövárosi Önkormányzat uzsoki utcai Kórház | Budapest | Hungary |
| Semmelweis Egyetem | Budapest | Hungary |
| Dombóvári Szent Lukács Egészségügyi Nonprofit Kft. | Dombóvár | Hungary |
| Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház | Miskolc | Hungary |
| Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft | Miskolc | Hungary |
| Pécsi Tudományegyetem | Pécs | Hungary |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ | Szeged | Hungary |
| Jávorszky Ödön Kórház | Vác | Hungary |
| Hospital Christus Muguerza del Parque | Chihuahua, Chih. | Mexico |
| Hospital Angeles Culiacan | Culiacan, Sinaloa | Mexico |
| Consultorio de Especialidad en Urologia Privado | Durango | Mexico |
| Médica Sur, S.A.B. de C.V. | Mexico City | Mexico |
| Hospital Angeles Lindavista | Mexico City, DF | Mexico |
| Consultorio Medico | Zapopan, Jalisco | Mexico |
| Catharina-ziekenhuis | Eindhoven | Netherlands |
| MC Haaglanden | The Hague | Netherlands |
| SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego | Bialystok | Poland |
| Centrum Medyczne Medur Sp. z o.o. | Bielsko-Biala | Poland |
| Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku | SÅ‚upsk | Poland |
| Private Medical Center SRL | Arad | Romania |
| Brasov Emergency Clinical County Hospital | Brasov | Romania |
| "Prof. Dr. Th. Burghele" Clinical Hospital | Bucharest | Romania |
| "Sfantul Ioan" Emergency Clinical Hospital | Bucharest | Romania |
| Dinu Uromedica | Bucharest | Romania |
| Fundeni Clinical Institute of Uronephrology and Renal Transplantation | Bucharest | Romania |
| PROVITA 2000 Medical Center | Constanța | Romania |
| "Dr. C.I. Parhon" Clinical Hospital | Iași | Romania |
| Vita Care Flav Medical Center | PiteÅŸti | Romania |
| Sibiu Emergency Clinical County Hospital | Sibiu | Romania |
| Dnipropetrovsk State Medical Academy | Dnipropetrovsk | Ukraine |
| Donetsk Regional Clinical Territorial Medical Association | Donetsk | Ukraine |
| Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval | Kharkiv | Ukraine |
| Kyiv City Clinical Hospital #3 | Kyiv | Ukraine |
| Odesa Regional Clinical Hospital | Odesa | Ukraine |
| Municipal Institution "Zaporizhzhia Regional Clinical Hospital" | Zaporizhzhya | Ukraine |
| Ipswich Hospital | Ipswich | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | United Kingdom |
| FG001 | Goserelin Acetate | Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months. |
| CS35/CS35A Safety Analysis Set |
|
| CS35/CS35A Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
CS35A Full Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 240 mg/480 mg | Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months. |
| BG001 | Goserelin Acetate | Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Median Baseline Serum Testosterone Levels | Median | Full Range | nanogram per milliliter (ng/mL) |
| |||||||||||||||
| Median Baseline Serum Prostate-specific Antigen Levels | Median | Full Range | ng/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin | PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Number | 95% Confidence Interval | percentage of no PSA-PFS | From baseline to 3 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin | PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Number | 95% Confidence Interval | percentage of no PFS failure | From baseline to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin | PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Number | 95% Confidence Interval | percentage of no PSA failure | From baseline to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin | Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Number | 95% Confidence Interval | percentage of no testosterone escape | From baseline to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin | Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Number | 95% Confidence Interval | percentage of no additional therapy | From baseline to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin | The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Number | 95% Confidence Interval | percentage of deaths | From baseline to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin | Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Median | Full Range | ng/mL | Baseline and after 1, 6, 12, 19, and 22 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin | Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed. | CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan. | Posted | Median | Full Range | ng/mL | Baseline and after 1, 6, 12, 19, and 22 months |
|
Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment).
Adverse events were evaluated at each visit. The analysis population was the CS35/CS35A (NCT00946920)/CS35A Safety Analysis Set (degarelix n=565; goserelin n=283). The analysis population was pre-specified in the study protocol and statistical analysis plan.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degarelix 240 mg/480 mg | Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months. | 58 | 565 | 430 | 565 | ||
| EG001 | Goserelin Acetate | Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months. | 33 | 283 | 197 | 283 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Coronary artery reocclusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Insulin-requiring type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Prostate cancer | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Tumour local invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Degarelix was considered to be non-inferior to goserelin with regard to the hazard ratio of PSA PFS failure rates as the upper limit of the two-sided 95% CI of the adjusted hazard ratio was less than the non-inferiority margin of 1.33.
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