Dose Finding Trial With a New Treatment (Degarelix) for P... | NCT00819156 | Trialant
NCT00819156
Sponsor
Ferring Pharmaceuticals
Status
Completed
Last Update Posted
Nov 30, 2023Actual
Enrollment
189Actual
Phase
Phase 2
Conditions
Prostate Cancer
Interventions
degarelix
Countries
Belgium
Germany
Hungary
Netherlands
Poland
Romania
Russia
South Africa
Protocol Section
Identification Module
NCT ID
NCT00819156
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FE200486 CS12
Secondary IDs
Not provided
Brief Title
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Official Title
An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months
Acronym
Not provided
Organization
Ferring PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Dec 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2004
Primary Completion Date
Jun 2005Actual
Completion Date
Sep 2005Actual
First Submitted Date
Jan 7, 2009
First Submission Date that Met QC Criteria
Jan 7, 2009
First Posted Date
Jan 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 22, 2009
Results First Submitted that Met QC Criteria
Mar 30, 2009
Results First Posted Date
Mar 31, 2009Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 8, 2023
Last Update Posted Date
Nov 30, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ferring PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.
Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Conditions Module
Conditions
Prostate Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
189Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Degarelix 200/80
Experimental
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix 200/120
Experimental
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix 200/160
Experimental
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix 240/80
Experimental
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix 240/120
Experimental
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
degarelix
Drug
Degarelix was given as subcutaneous injections.
Degarelix 200/120
Degarelix 200/160
Degarelix 200/80
Degarelix 240/120
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
Number of patients who achieved a testosterone level considered a castration level.
12 months
Secondary Outcomes
Measure
Description
Time Frame
Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28
Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
Day 28 - 364
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent prior to any study related procedures
Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months
Exclusion Criteria:
Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
Hypersensitivity towards any component of degarelix or mannitol
Cancer disease within the last 5 years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Known hepatic disease
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier precluding adequate understanding or cooperation
Having received an investigational product within the last 12 weeks preceding the trial
Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008 Oct;54(4):805-13. doi: 10.1016/j.eururo.2008.04.065. Epub 2008 May 8.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Two hundred and sixteen patients were screened. Twenty-seven were screening failures. Two randomized patients were not treated: one withdrew consent and the other had an elevated alanine aminotransferase value (an exclusion criteria found after randomization).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
FG001
Degarelix 200/120
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: degarelix
Degarelix 240/160
Experimental
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix 240/160
Degarelix 240/80
FE200486
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
Day 28
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
Day 3
Days to 50 Percent Reduction in Prostate-Specific Antigen
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
Day 0 (post dose) to Day 364
Days to 90 Percent Reduction in Prostate-Specific Antigen
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
Day 0 (post dose) to Day 364
Days to Prostate-Specific Antigen Progression
Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
Day 0 (post dose) to Day 364
Median Serum Testosterone Levels
Day 0 (Baseline), Days 1,3,7,14, and 364
Median Prostate-specific Antigen Levels
Day 0 (Baseline), Days 3, 7, 14, and 364
Median Values of Di-Hydrotestosterone
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Median Values for Serum Luteinizing Hormone
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Median Values for Follicle Stimulation Hormone
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
The Number of Patients With Abnormal Liver Function Tests
The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.
364 days
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.
Day 364
Ghent
Belgium
UZ Gasthuisberg
Leuven
Belgium
Vivantes Klinikum am Urban
Berlin
Germany
Loretto Krankenhaus
Freiburg im Breisgau
Germany
Euromed AG Klinik
Fürth
Germany
Urologische Universitätsklinikum
Mannheim
Germany
Bajcsy-Zsilinszky Hospital, Urology
Budapest
Hungary
Jahn Ferenc Dél Pesti Hospital, Urology
Budapest
Hungary
Pez Aladar County Hospital
Győr
Hungary
BAZ County Hospital
Miskolc
Hungary
Hospital of Local Gov. Szeged, Urology
Szeged
Hungary
MÁV Hospital, Urology
Szolnok
Hungary
AMC
Amsterdam
Netherlands
Atrium MC
Heerlen
Netherlands
Wojewódzki Szpital Specjalisttyczny
Siedlce
Poland
Wojewódzki Szpital Specjalisttyczny
Słupsk
Poland
CF2 Hospital
Bucharest
Romania
Dr. Th Burghele Hospital
Bucharest
Romania
Fundeni Hospital
Bucharest
Romania
Sf. Ioan Hospital
Bucharest
Romania
Botkin Clinical Hospital
Moscow
Russia
City Hospital #1
Moscow
Russia
City Hospital #29
Moscow
Russia
City Hospital #50
Moscow
Russia
City Hospital #60
Moscow
Russia
Institute of Urology of MoH
Moscow
Russia
"Andros" Urology Clinic
Saint Petersburg
Russia
City Hospital #15
Saint Petersburg
Russia
City Hospital #26
Saint Petersburg
Russia
Military Medical Academy, Urology
Saint Petersburg
Russia
Pavlov Medical School Outpatient
Saint Petersburg
Russia
Pavlov medical School, Urology
Saint Petersburg
Russia
Sct Petersburg State Medical Academy
Saint Petersburg
Russia
370 Clarke Road
Glenwood, Durban
South Africa
Pretoria Urology Hospital
Hatfield, Pretoria
South Africa
WITS Medical School
Parktown
South Africa
401B Medical Centre
Pietermaritzburg
South Africa
Sunninghill Clinic
Sunninghill
South Africa
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
FG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
FG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
FG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
FG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
FG00030 subjects
FG00133 subjects
FG00232 subjects
FG00330 subjects
FG00433 subjects
FG00531 subjects
Randomised and Treated (ITT Population)
FG00030 subjects
FG00132 subjects
FG00232 subjects
FG00330 subjects
FG00433 subjects
FG00530 subjects
COMPLETED
FG00020 subjects
FG00123 subjects
FG00226 subjects
FG00328 subjects
FG00427 subjects
FG00523 subjects
NOT COMPLETED
FG00010 subjects
FG00110 subjects
FG0026 subjects
FG0032 subjects
FG0046 subjects
FG0058 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
FG0053 subjects
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Testosterone >1ng/ml from Day 28+
FG0005 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Testosterone >=.5ng/ml 2 visits
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Prostate-specific antigen progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
BG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
BG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
BG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
BG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
BG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG00132
BG00232
BG00330
BG00433
BG00530
BG006187
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00069.9± 8.27
BG00170.6± 7.72
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Number of Patients at Each Stage of Prostate Cancer
Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tummors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
Number
patients
Title
Denominators
Categories
Localized
Title
Measurements
BG0008
BG001
Patient Counts by Gleason Score
The Gleason Score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10 with low numbers being the least aggressive and 10 being the most aggressive.
Number
participants
Title
Denominators
Categories
unknown
Title
Measurements
BG0000
BG001
Body Mass Index
Body mass index is a measure of body fat based on height and weight.
Mean
Standard Deviation
kilograms per square meter
Title
Denominators
Categories
Title
Measurements
BG00026.4± 3.5(18.1 to 36)
BG00126.4± 3.74
Days Since Diagnosis of Prostate Cancer
The mean number of days that have passed since a diagnosis of prostate cancer was made for each patient.
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG000493± 849
BG001122± 230
Median Serum Testosterone Level
Testosterone is a steroid hormone from the androgen group, and the principal male sex hormone. This test measures the amount of testosterone in the blood. Androgen deprivation is used to manage prostate cancer.
Median
Full Range
nanogram / milliliter
Title
Denominators
Categories
Title
Measurements
BG0004.47(0.816 to 7.1)
BG001
Serum Prostate-specific Antigen
Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood. High PSA levels have a positive correlation to prostate cancer.
Median
Full Range
nanogram / milliliter
Title
Denominators
Categories
Title
Measurements
BG00015.2(2.6 to 332)
BG001
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
Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
Number of patients who achieved a testosterone level considered a castration level.
ITT population.
Posted
Number
participants
12 months
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00028
OG00125
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG00017(41 to 78)
OG00121(64 to 95)
OG00226(81 to 100)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Percentage
61
95
41
78
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG001
Secondary
Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28
Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
ITT population of patients with testoterone measurements <=0.5 nanogram/milliliter at Day 28.
Posted
Number
participants
Day 28 - 364
ID
Title
Description
OG000
Maintenance Dose of 80 Milligram Per Cycle
The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined.
OG001
Maintenance Dose of 120 Milligram Per Cycle
The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined.
OG002
Maintenance Dose of 160 Milligram Per Cycle
The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.
Secondary
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
ITT population.
Posted
Number
participants
Day 28
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Secondary
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
ITT population.
Posted
Number
participants
Day 3
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Secondary
Days to 50 Percent Reduction in Prostate-Specific Antigen
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
ITT population
Posted
Median
Full Range
days
Day 0 (post dose) to Day 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Secondary
Days to 90 Percent Reduction in Prostate-Specific Antigen
Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
ITT population
Posted
Median
Full Range
days
Day 0 (post dose) to Day 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Secondary
Days to Prostate-Specific Antigen Progression
Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.
Posted
Median
Full Range
days
Day 0 (post dose) to Day 364
ID
Title
Description
OG000
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/120
Secondary
Median Serum Testosterone Levels
ITT population
Posted
Median
Full Range
nanogram/milliliter
Day 0 (Baseline), Days 1,3,7,14, and 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Secondary
Median Prostate-specific Antigen Levels
ITT population
Posted
Median
Full Range
nanogram / milliliter
Day 0 (Baseline), Days 3, 7, 14, and 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Secondary
Median Values of Di-Hydrotestosterone
ITT population
Posted
Median
Full Range
picogram / milliliter
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Secondary
Median Values for Serum Luteinizing Hormone
ITT population
Posted
Median
Full Range
international units / liter
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Secondary
Median Values for Follicle Stimulation Hormone
ITT population
Posted
Median
Full Range
international units / liter
Day 0 (Baseline), Days 1, 3, 7, 14, and 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Secondary
The Number of Patients With Abnormal Liver Function Tests
The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.
ITT population
Posted
Number
participants
364 days
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Secondary
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.
ITT population
Posted
Number
participants
Day 364
ID
Title
Description
OG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
OG003
Degarelix 240/80
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
3
17
EG001
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
6
21
EG002
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
4
24
EG003
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
4
19
EG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
6
23
EG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
4
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG0030 events0 affected30 at risk
EG0040 events0 affected33 at risk
EG0051 events1 affected30 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Corneal defect
Eye disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Disease progression
General disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Acoustic neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events1 affected32 at risk
EG003
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Metastases to penis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Depression
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Calculus bladder
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Hypertension
Vascular disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected32 at risk
EG0030 events0 affected30 at risk
EG0040 events0 affected33 at risk
EG0052 events2 affected30 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0002 events1 affected30 at risk
EG0014 events3 affected32 at risk
EG0022 events2 affected30 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Injection site pain
General disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0013 events3 affected32 at risk
EG00217 events6 affected32 at risk
EG003
Fatigue
General disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected32 at risk
EG0023 events2 affected32 at risk
EG003
Injection site swelling
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0014 events2 affected32 at risk
EG0027 events2 affected32 at risk
EG003
Pyrexia
General disorders
MedDRA 7.0
Systematic Assessment
EG0004 events3 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Injection site erythema
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Asthenia
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Injection site inflammation
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0012 events2 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0012 events2 affected32 at risk
EG0024 events2 affected32 at risk
EG003
Influenza
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0003 events2 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Weight increase
Investigations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0013 events3 affected32 at risk
EG0024 events4 affected32 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected32 at risk
EG0024 events3 affected32 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected32 at risk
EG0023 events2 affected32 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Blood urea increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Weight decreased
Investigations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0013 events3 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected32 at risk
EG0023 events2 affected32 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected32 at risk
EG0022 events1 affected32 at risk
EG003
Headache
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Syncope vasovagal
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected32 at risk
EG0023 events3 affected32 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Testicular atrophy
Reproductive system and breast disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected32 at risk
EG0023 events2 affected32 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0013 events2 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0
Systematic Assessment
EG0002 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected32 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected32 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected32 at risk
EG003
Hot flush
Vascular disorders
MedDRA 7.0
Systematic Assessment
EG00016 events14 affected30 at risk
EG0018 events8 affected32 at risk
EG00213 events10 affected32 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG002
Percentage
96
95
81
100
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG003
Percentage
90
95
73
98
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG004
Percentage
90
95
73
98
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG005
Percentage
92
95
74
99
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
Units
Counts
Participants
OG00048
OG00150
OG00249
Title
Denominators
Categories
Title
Measurements
OG00044(80 to 98)
OG00148(86 to 100)
OG00249(93 to 100)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Percentage
92
95
80
98
The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG001
Percentage
96
95
86
100
The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG002
Percentage
100
95
93
100
The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.
Superiority or Other (legacy)
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Title
Measurements
OG00021(51 to 85)
OG00129(75 to 98)
OG00231(84 to 100)
OG00329(83 to 100)
OG00431(80 to 99)
OG00527(77 to 99)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Percentage
70
95
51
85
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG001
Percentage
91
95
75
98
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG002
Percentage
97
95
84
100
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG003
Percentage
97
95
83
100
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG004
Percentage
94
95
80
99
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG005
Percentage
93
95
77
99
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Title
Measurements
OG00025(65 to 94)
OG00130(79 to 99)
OG00227(70 to 96)
OG00328(78 to 99)
OG00430(76 to 98)
OG00528(78 to 99)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Percentage
83
95
65
94
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG001
Percentage
94
95
79
99
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG002
Percentage
87
95
70
96
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG003
Percentage
93
95
78
99
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG004
Percentage
91
95
76
98
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG005
Percentage
93
95
78
99
The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.
Superiority or Other (legacy)
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Title
Measurements
OG00014(7 to 224)
OG00114(3 to 84)
OG00214(3 to 42)
OG00314(3 to 56)
OG00414(3 to 84)
OG00514(3 to 56)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
Log Rank
0.0933
95
Superiority or Other (legacy)
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Title
Measurements
OG00056(28 to 168)
OG00156(14 to 336)
OG00256(14 to 336)
OG00356(14 to 196)
OG00456(28 to 364)
OG00556(14 to 196)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
Log Rank
0.165
95
Superiority or Other (legacy)
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00032
OG00132
OG00230
OG00333
OG00430
Title
Denominators
Categories
Title
Measurements
OG000224(140 to 308)
OG001308(308 to 308)
OG002280(252 to 336)
OG003224(126 to 364)
OG004140(140 to 140)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Log Rank
0.429
95
Superiority or Other (legacy)
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Day 0 (Baseline)
Title
Measurements
OG0004.47(0.816 to 7.1)
OG0013.93(1.53 to 9.29)
OG0024.79(2.8 to 9.47)
OG0034.28(1.4 to 10.2)
OG0044.07(2.02 to 7.7)
OG0053.88(1.69 to 8.63)
Day 1 (n=30,32,32,30,33,30)
Title
Measurements
OG0000.654(0.167 to 1.81)
OG0010.436(0.207 to 1.21)
OG0020.465(0.287 to 2.44)
OG003
Day 3 (n=30,32,31,30,33,30)
Title
Measurements
OG0000.308(0.121 to 2.81)
OG0010.26(0.139 to 0.657)
OG0020.281(0.125 to 0.64)
OG003
Day 7 (n=30,32,32,30,33,28)
Title
Measurements
OG0000.283(0.098 to 4)
OG0010.237(0.066 to 1.43)
OG0020.198(0.087 to 0.808)
OG003
Day 14 (n=30,32,32,30,33,29)
Title
Measurements
OG0000.173(0.025 to 4.77)
OG0010.144(0.054 to 1.62)
OG0020.122(0.025 to 0.617)
OG003
Day 364 (n=20,23,26,28,27,23)
Title
Measurements
OG0000.137(0.025 to 1.31)
OG0010.124(0.025 to 0.53)
OG0020.105(0.025 to 0.221)
OG003
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Day 0 (Baseline)
Title
Measurements
OG00015.2(2.6 to 332)
OG00131.5(3.3 to 1730)
OG00231.5(2.6 to 901)
OG00323.1(3.6 to 586)
OG00435.3(2.4 to 1110)
OG00532(2 to 1297)
Day 3 (n=29,30,28,29,33,28)
Title
Measurements
OG00013.7(2.4 to 207)
OG00129.9(3 to 1061)
OG00227.8(2 to 443)
OG003
Day 7 (n=30,32,32,30,33,28)
Title
Measurements
OG00010.6(1.9 to 138)
OG00118.5(2.4 to 420)
OG00216.5(1.8 to 234)
OG003
Day 14 (n=29,31,32,29,33,28)
Title
Measurements
OG0007.9(1 to 69.5)
OG00110.9(1.8 to 155)
OG0029.9(1.3 to 142)
OG003
Day 364 (n=20,23,26,28,27,22)
Title
Measurements
OG0000.45(0.1 to 5.5)
OG0010.6(0.1 to 21.2)
OG0020.95(0.1 to 21.6)
OG003
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Day 0 (Baseline; n=25,30,26,23,23,25)
Title
Measurements
OG000430(140 to 2600)
OG001330(94 to 760)
OG002310(170 to 630)
OG003330(20 to 760)
OG004350(160 to 640)
OG005290(160 to 550)
Day 1 (n=23,27,25,24,26,24)
Title
Measurements
OG000130(41 to 320)
OG00195(54 to 290)
OG002110(44 to 250)
OG003
Day 3 (n=23,27,25,25,27,25)
Title
Measurements
OG00082(22 to 150)
OG00167(32 to 130)
OG00270(22 to 130)
OG003
Day 7 (n=26,30,24,26,30,22)
Title
Measurements
OG00063(10 to 260)
OG00165(31 to 220)
OG00261.5(22 to 150)
OG003
Day 14 (n=19,27,25,23,25,27)
Title
Measurements
OG00068(10 to 440)
OG00151(22 to 120)
OG00242(10 to 110)
OG003
Day 364 (n=17,21,20,25,25,21)
Title
Measurements
OG00041(10 to 79)
OG00139(10 to 73)
OG00234(10 to 72)
OG003
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Day 0 (Baseline)
Title
Measurements
OG0003.8(0.5 to 9.6)
OG0014(1.6 to 15)
OG0025.05(1.2 to 27.6)
OG0035.6(1 to 18)
OG0043.9(1.6 to 25.9)
OG0056(1.6 to 19.5)
Day 1 (n=28,30,32,28,31,30)
Title
Measurements
OG0000.8(0.05 to 5.7)
OG0010.65(0.3 to 3.4)
OG0020.7(0.2 to 4.6)
OG003
Day 3 (n=29,30,28,29,33,28)
Title
Measurements
OG0000.5(0.1 to 2.7)
OG0010.5(0.2 to 1.9)
OG0020.5(0.2 to 2.1)
OG003
Day 7 (n=30,32,32,30,33,28)
Title
Measurements
OG0000.7(0.05 to 5.7)
OG0010.5(0.2 to 2.5)
OG0020.6(0.2 to 3.4)
OG003
Day 14 (n=29,31,32,29,33,28)
Title
Measurements
OG0000.5(0.05 to 7.4)
OG0010.3(0.1 to 2.8)
OG0020.35(0.05 to 4.5)
OG003
Day 364 (n=20,23,26,28,27,22)
Title
Measurements
OG0000.3(0.05 to 1.5)
OG0010.3(0.05 to 2.3)
OG0020.2(0.05 to 0.6)
OG003
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Day 0 (Baseline)
Title
Measurements
OG0008.35(2.3 to 45.4)
OG0019.25(2.4 to 39.2)
OG0029(3.8 to 40.7)
OG0039.7(4.1 to 61.7)
OG0047(2.3 to 76.1)
OG00510.2(1.8 to 67.9)
Day 1 (n=28,30,32,28,31,30)
Title
Measurements
OG0005.15(1.4 to 28.6)
OG0015.65(1.5 to 24.8)
OG0025.35(2.3 to 24.8)
OG003
Day 3 (n=29,30,28,29,33,28)
Title
Measurements
OG0002.9(0.8 to 14.4)
OG0013.15(1 to 14.1)
OG0023.25(1.2 to 13.5)
OG003
Day 7 (n=30,32,32,30,33,28)
Title
Measurements
OG0002.7(0.3 to 9.3)
OG0011.95(0.6 to 12.9)
OG0021.85(0.8 to 8.7)
OG003
Day 14 (n=29,31,32,29,33,28)
Title
Measurements
OG0001.6(0.05 to 11.5)
OG0011.1(0.3 to 11.2)
OG0020.9(0.2 to 7.9)
OG003
Day 364 (n=20,23,26,28,27,22)
Title
Measurements
OG0001.8(0.2 to 7)
OG0011.5(0.2 to 7.6)
OG0021.45(0.2 to 6.4)
OG003
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Units
Counts
Participants
OG00030
OG00132
OG00232
OG00330
OG00433
OG00530
Title
Denominators
Categories
Abnormal alanine aminotransferase (ALT)
Title
Measurements
OG0006
OG00110
OG00215
OG00313
OG0048
OG0059
Abnormal aspartate aminotransferase
Title
Measurements
OG0007
OG00110
OG00215
OG003
Abnormal bilirubin
Title
Measurements
OG0002
OG0015
OG0021
OG003
ALT >3x ULN
Title
Measurements
OG0003
OG0018
OG00212
OG003
ALT>3x ULN and bilirubin >1.5x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
OG004
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
OG005
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.