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The maintenance doses were too low to maintain testosterone suppression
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To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients
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 (FDA regulated intervention is therefore ticked "YES").
The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 80/80 + 40 | Experimental | In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
|
| Degarelix 40/40 + 40 | Experimental | In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
|
| Degarelix 80 + 20 | Experimental | In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | Given as a subcutaneous injection once every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Tests | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN. | 3 years |
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Testosterone After 1, 2, and 3 Years | 3 years |
Not provided
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
Not provided
Not provided
Participants who responded to degarelix in FE200486 CS02 (NCT00819247) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the UK or until the study was discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 80/80 + 40 | In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| FG001 | Degarelix 40/40 + 40 | In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| FG002 | Degarelix 80 + 20 | In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 80/80 + 40 | In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Liver Function Tests | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN. | The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A. | Posted | Number | participants | 3 years |
|
Not provided
Not provided
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 80/80 + 40 | In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 4.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ferring Pharmaceuticals | Clinical Development Support | DK0-Disclosure@ferring.com |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
Not provided
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Not provided
| Degarelix | Drug | Given as a subcutaneous injection once every 4 weeks. |
|
|
| Degarelix | Drug | Given as a subcutaneous injection once every 4 weeks. |
|
|
| Insufficient testosterone suppr |
|
| Insufficient PSA and testosterone suppr |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Disease progression |
|
| Protocol Violation |
|
| Death |
|
| Administrative reasons |
|
| Degarelix 40/40 + 40 |
In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| BG002 | Degarelix 80 + 20 | In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| 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 |
|
| Number of Participants With Curative Intent | A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy. | Number | participants |
|
| Number of Participants 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 tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor. | Number | participants |
|
| Body mass index | Body mass index is a measure of body fat based on height and weight. | Mean | Standard Deviation | kilogram per square meter |
|
| Serum testosterone levels | Median | Inter-Quartile Range | nanogram per milliliter |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| OG001 | Degarelix 40/40 + 40 | In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
| OG002 | Degarelix 80 + 20 | In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. |
|
|
| Primary | Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline. | These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A). | Posted | Number | participants | 3 years |
|
|
|
| Secondary | Serum Levels of Testosterone After 1, 2, and 3 Years | Posted | Median | Full Range | nanogram per milliliter | 3 years |
|
|
|
| 10 |
| 42 |
| EG001 | Degarelix 40/40 + 40 | In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. | 14 | 40 |
| EG002 | Degarelix 80 + 20 | In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks. | 10 | 35 |
| Angina unstable | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Bronchiectasis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Cardiac function disturbance postoperative | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 4.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.1 | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Alveolitis fibrosing | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Convalescent | Social circumstances | MedDRA 4.1 | Systematic Assessment |
|
| Suprapubic catheter insertion | Surgical and medical procedures | MedDRA 4.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Catheter related complication | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Arthraligia | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Nasopharangytis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 4.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 4.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 4.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 4.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 4.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Testicular atrophy | Reproductive system and breast disorders | MedDRA 4.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 4.1 | 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.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| Systolic blood pressure <=90 and decrease >=20 |
|
| Systolic blood pressure >=180 and increase >=20 |
|
| Heart rate <=50 and decrease >=15 |
|
| Heart rate >=120 and increase >=15 |
|
| Body weight decrease of >=7 percent |
|
| Body weight increase of >=7 percent |
|
|
| 3 years (n=8,5,6) |
|