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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001279-35 | EudraCT Number |
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Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 11.25mg | Experimental | 11.25mg, SC on Day 1 and Day 92 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin Pamoate 11.25mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183 | Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183 | At Day 29 and 183 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose | Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations. |
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Inclusion Criteria:
Exclusion Criteria:
Prior hormonal therapy for prostate cancer
Prior surgery or radiotherapy of prostate cancer with curative intent unless disease is verified by a rising prostate specific antigen (PSA) concentration on follow up (elevated PSA values on last two tests conducted at least a month apart) and the patient is eligible for androgen deprivation therapy
Presence or history of any other malignancy except for non melanoma skin cancer adequately treated at least 2 years before study entry
Painful local bone lesions or spinal lesions which may lead to compression
History of myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, Class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within six months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or uncontrolled ventricular arrhythmias
Any condition in opinion of the Investigator, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study, compromises the objective of the study or places the patient at unacceptable risk if he participates in the study
Abnormal haematological, hepatic or renal functions:
Known hypersensitivity to the study treatment, to any of its excipients
Known active use of recreational drug or alcohol dependence in the opinion of the Investigator
Any current use or use within six months prior to start of treatment, of medications which are known to affect the metabolism and/or secretion of androgenic hormones: e.g. ketoconazole, aminoglutethimide, oestrogens, and progesterone
Use of systemic corticosteroids (inhaled corticosteroids and topical application of corticosteroids are permitted)
Aged ≥90 years for the main study and ≥80 years for those included in the pharmacokinetic (PK) patient population
Participation in any other study or receipt of any investigational compound in the 30 days (or five times the elimination half life if this is longer) prior to study entry
Any skin or other condition that may preclude s.c. injection administration
Known brain or epidural metastases.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, Uro-Oncology | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pleven | Bulgaria | |||||
A total of 139 subjects were screened and 13 subjects were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triptorelin Pamoate | Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| At Day 92 |
| Probability of Testosterone <50 ng/dL | Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis. LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry | Day 29 through Day 183 |
| Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95 | Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations. | Day 95 |
| Time to Achieve Castration (Tcast) | Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement) | Up to Day 36 |
| Plasma Triptorelin Levels (Cmin) | Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed. | At Day 92 and 183 |
| Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects | Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented. | From Day 1 (Baseline) to Day 183 (End of study) |
| Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit) | 0-4 ng/mL (normal PSA value) >4 ng/mL (abnormal PSA levels) | At Day 183 |
| Clinically Apparent Tumor Progression | Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit). | Day 92 and 183 |
| Percentage of Subjects With Adverse Events | Up to Day 183 |
| Time to Cmax (Tmax) of Triptorelin | At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 |
| Peak Plasma Concentration Value (Cmax) of Triptorelin | At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 |
| Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin | At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 |
| Cmin of Triptorelin in Subset of 18 Subjects | At Day 92 and 183 |
| Plovdiv |
| Bulgaria |
| Shumen | Bulgaria |
| Varna | Bulgaria |
| Suresnes | France |
| Daugavpils | Latvia |
| Riga | Latvia |
| Kutno | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Bucharest | Romania |
| Craiova | Romania |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Triptorelin Pamoate | Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
| ||||||||||||||||||||||
| Prostate Specific Antigen (PSA) | Mean | Standard Deviation | ng/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183 | Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183 | N=Number of subjects attending the visit | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 29 and 183 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose | Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations. | Initially Castrated (IC1) population: All treated subjects with testosterone levels <50 ng/dL at Day 29 or at Day 36, assessed with the LC-MS/MS method and missing data imputed by immunoassay method. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 92 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Probability of Testosterone <50 ng/dL | Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis. LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry | Intention-to-treat (ITT) population: All treated subjects | Posted | Number | 95% Confidence Interval | Proportion of subjects | Day 29 through Day 183 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95 | Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations. | IC1 population. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 95 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Achieve Castration (Tcast) | Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement) | ITT population | Posted | Median | 95% Confidence Interval | Day | Up to Day 36 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Triptorelin Levels (Cmin) | Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed. | ITT population. No samples were collected from 4 subjects at Day 92 and 9 subjects at Day 183 | Posted | Mean | Standard Deviation | ng/mL | At Day 92 and 183 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects | Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented. | ITT population at End of Study (Day 183). One subject had no data. | Posted | Mean | Standard Deviation | Percentage Change | From Day 1 (Baseline) to Day 183 (End of study) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit) | 0-4 ng/mL (normal PSA value) >4 ng/mL (abnormal PSA levels) | Subjects completed Day 183 visit (End of Study) | Posted | Number | Percentage of subjects | At Day 183 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinically Apparent Tumor Progression | Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit). | ITT population | Posted | Number | participants | Day 92 and 183 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Adverse Events | All subjects who received at least one dose of study treatment were included in safety population. | Posted | Number | Percentage of subjects | Up to Day 183 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Cmax (Tmax) of Triptorelin | Pharmacokinetic (PK) profile was assessed in a subset of 18 subjects. | Posted | Median | Full Range | Hours | At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Peak Plasma Concentration Value (Cmax) of Triptorelin | PK profile was assessed in a subset of 18 subjects. | Posted | Mean | Standard Deviation | ng/mL | At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin | PK profile was assessed in a subset of 18 subjects. | Posted | Mean | Standard Deviation | h*ng/mL | At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Cmin of Triptorelin in Subset of 18 Subjects | Day 92: Four subjects (presenting particularly high levels of triptorelin) were excluded from 18-subject subset. | Posted | Mean | Standard Deviation | ng/mL | At Day 92 and 183 |
|
|
Up to Day 183
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triptorelin Pamoate 11.25 mg | Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92 | 6 | 126 | 45 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot Flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection Site Haematoma | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Breast Pain | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
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| Breast Swelling | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Breast Tenderness | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Weight Increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Weight Decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Loss Of Consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypotrichosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Oncology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Day 92 |
| |||||
| Day 183 (N=117) |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| End of Study (0-4 ng/mL) |
| |||||
| End of Study (>4 ng/mL) |
|
|
| Denominators |
|---|
| Categories |
|---|
| Any Adverse Events |
| |||||
| Any Serious Adverse Events (SAEs) |
| |||||
| Any Treatment Emergent Adverse Events (TEAEs) |
| |||||
| TEAEs Leading to Withdrawal |
| |||||
| TEAEs Leading to Death |
| |||||
| Maximum Grade NCI-CTC of TEAEs: Grade 5 |
| |||||
| Maximum Grade NCI-CTC of TEAEs: Grade 4 |
| |||||
| Maximum Grade NCI-CTC of TEAEs: Grade 3 |
| |||||
| Maximum Grade NCI-CTC of TEAEs: Grade 2 |
| |||||
| Maximum Grade NCI-CTC of TEAEs: Grade 1 |
| |||||
| Most serious causality of TEAEs: Related |
| |||||
| Most serious causality of TEAEs: Not related |
|
| Denominators |
|---|
| Categories |
|---|
|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Day 92 (N=14) |
| |||||
| Day 183 (N=18) |
|