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The purpose of this study is to assess the safety and efficacy of teverelix TFA in the treatment of advanced prostate cancer
After being informed about the study and potential risks, all patients giving written informed consent will undergo an up to 7 day screening period to determine eligibility for study entry. On Day 0, patients who meet the eligibility requirements will be enrolled in an open-label manner and will receive a loading dose of teverelix TFA (one subcutaneous (SC) injection in the abdomen and one intramuscular (IM) injection in the buttock). Patients will then receive maintenance doses of teverelix TFA (one SC injection in the abdomen) at 4- or 6-weekly intervals up to week 24. The patients will return for a final assessment 4 weeks after their last maintenance dose injection.
The initial dosing regimen to be tested (Group 1) is:
Loading Dose = 120 mg teverelix TFA SC + 120 mg teverelix TFA IM Maintenance Dose = 120 mg teverelix TFA SC every 6 weeks
If this dosing regimen is unsuccessful (more than 2 (of 20) patients fail treatment) then recruitment to Group 1 will end and enrollment in Group 2 will open.
The dosing regimen that may be tested (Group 2) is:
Loading Dose = 180 mg teverelix TFA SC + 180 mg teverelix TFA IM Maintenance Dose = 180 mg teverelix TFA SC every 6 weeks
If this dosing regimen is unsuccessful (more than 6 (of 60) patients fail treatment) then recruitment to Group 2 will end and the study will be terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teverelix TFA 120 mg 6-weekly | Experimental | Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 |
|
| Teverelix TFA 180 mg 6-weekly | Experimental | Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teverelix TFA 120 mg | Drug | Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone (T) Levels (Castrate) at Week 4 | Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 28. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone (T) Levels (0.2 ng/mL) at Week 4 | Proportion of participants achieving castration level with serum T <0.2 ng/mL at Day 28 | 4 weeks |
| Testosterone (T) Levels (Castrate) at Week 6 | Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albertas Ulys, MD | National Cancer Institute, Vilnius, Lithuania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | LT-50161 | Lithuania | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Teverelix TFA 120 mg 6-weekly | Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24 |
| FG001 | Teverelix TFA 180 mg 6-weekly | Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teverelix TFA 120 mg 6-weekly | Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24 |
| 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 | Testosterone (T) Levels (Castrate) at Week 4 | Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 28. | Posted | Count of Participants | Participants | 4 weeks |
|
Until 30 days after last injection of study drug
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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 | Teverelix TFA 120 mg 6-weekly | Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 120 mg: Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Carotid Artery Stenosis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | The patient was hospitalized for planned treatment due to Left Carotid Artery Stenosis (CTCAE Grade 3). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol MacLean | Antev Ltd | +447525177617 | cmaclean@antev.co.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2022 | Jan 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2023 | Jan 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Adaptive design - enrollment will open in Group 1 (6-weekly dosing regimen). Only if Group 1 dosing regimen is unsuccessful will enrollment open in Group 2 (4-weekly dosing regimen)
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| teverelix TFA 180 mg | Drug | Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24 |
|
| 6 weeks |
| Testosterone (T) Levels (0.2 ng/mL) at Week 6 | Proportion of participants achieving profound castration level (0.2 ng/mL) with serum T <0.5 ng/mL at Day 42 | 6 weeks |
| Testosterone Levels (Castrate) at Week 24 | Proportion of participants achieving a T castration rate over 168 days of treatment period | 24 weeks |
| Testosterone Levels (0.2 ng/mL) at Week 24 | Proportion of participants achieving profound castration rate (<0.2 ng/mL) over 168 days of treatment period | 24 weeks |
| Time to Achieve Castrate Levels of Testosterone (T) | Mean time to T levels falling below castration level (<0.5 ng/mL) for the first time | 4 weeks |
| Time to Escape Castrate Levels of Testosterone (T) | Mean time to (first) overstep of T castration level after achieving castration | Approximately 30 weeks |
| Luteinizing Hormone (LH) Levels (Castrate) at Week 4 | Proportion of participants achieving castration level for LH (LH <1.1 U/L) at Day 28 | 4 weeks |
| Luteinizing Hormone (LH) Levels (Castrate) at Week 24 | Proportion of participants with effective LH castration rate over 168 days of treatment period | 24 weeks |
| Time to Achieve Castrate Levels of Luteinizing Hormone (LH) | Mean time to LH levels falling below castration level (LH <1.1 U/L) for the first time | 4 weeks |
| Time to Escape Castrate Levels of Luteinizing Hormone (LH) | Mean time to (first) overstep of LH castration level after achieving castration | 24 weeks |
| Change in Testosterone Levels Over Time (Change From Baseline at Day 168) | The change in testosterone levels over time (Change from Baseline at Day 168) | 24 weeks |
| Change in LH Levels Over Time | The change in LH levels over time | 24 weeks |
| Change in FSH Levels Over Time | The change in FSH levels over time | 24 weeks |
| Area Under the Concentration Time-curve From Time Zero up to the Last Quantifiable Concentration at Time Point t (AUC0-t) | Area under the concentration time-curve from time zero up to the last quantifiable concentration at time point t (Ct), calculated using the linear up/log down trapezoidal rule. | 24 weeks |
| Area Under the Concentration Time-curve From Time Zero up to the Concentration at Time Point t1 After Which the Concentrations Start to Rise Again Towards a Second Peak (AUC0-t1) | Area under the concentration time-curve from time zero up to the concentration at time point t1 after which the concentrations start to rise again towards a second peak, calculated using the linear up/log down trapezoidal rule. t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC). | 24 weeks |
| Maximum Observed Plasma Teverelix Concentration After Administration (Cmax) | The maximum observed plasma teverelix concentration after administration (Cmax) | 24 weeks |
| Maximum Observed Concentration After Administration From Zero up to Time Point t1 (Cmax,0-t1) | The maximum observed concentration after administration from zero up to time point t1 (Cmax,0-t1) | 24 weeks |
| Maximum Observed Concentration After Administration From Time Point t1 up to Time Point t (Cmax,t1-t) | The maximum observed concentration after administration from time point t1 up to time point t (Cmax,t1-t) | 24 weeks |
| Time to Reach Cmax After Dosing (Tmax) | The time to reach Cmax after dosing (tmax) | 24 weeks |
| Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1) | The time to reach Cmax,0-t1 after dosing (tmax,0-t1) | 24 weeks |
| Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t) | The time to reach Cmax,t1-t after dosing (tmax,t1-t) | 24 weeks |
| Apparent Terminal Elimination Rate Constant (Lambda-z) | The apparent terminal elimination rate constant (lambda-z) | 24 weeks |
| Apparent Terminal Plasma Half-life (t½) | Apparent terminal plasma half-life, calculated as: ln 2 / lambda-z | 24 weeks |
| Area Under the Concentration Time-curve From Time Zero up to Infinity (∞)(AUC0-∞) | Area under the concentration time-curve from time zero up to infinity (∞),calculated using the linear up/log down trapezoidal rule. | 24 weeks |
| Prostate Specific Antigen (PSA) Reduction (≥50 Percent) | Number of participants with a PSA response of ≥50 percent reduction at the Day 168 visit | 24 weeks |
| PSA Response Rate at Day 28 | PSA response is defined as >50% decline in PSA at Day 28. PSA response rate is the number of subjects with a PSA response. | 24 weeks |
| PSA Response ≥50% at Day 168 | The number of subjects with a PSA response ≥50% at Day 168 | 24 weeks |
| Luteinizing Hormone (LH) Mean % Reduction at Day 168 | Luteinizing Hormone (LH) - the mean % reduction at Day 168 | 24 weeks |
| Testosterone (T) Mean % Reduction at Day 168 | Testosterone (T) - the mean % reduction at Day 168 | 24 weeks |
| Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168 | Follicle Stimulating Hormone (FSH) - the mean % reduction at Day 168 | 24 weeks |
| Treatment-emergent Adverse Events (AEs) | Number of participants with treatment-emergent AEs | 24 weeks |
| ECG QTcF Interval Prolongation >450 Msec at Day 28 | ECG QTcF Interval prolongation >450 msec at Day 28 study visit | 24 weeks |
| Injection Site Reactions (ISRs) | Number of participants with ISRs at each visit during the 168 days treatment period | 24 weeks |
| Klaipeda University Hospital |
| KlaipÄ—da |
| LT-92288 |
| Lithuania |
| National Cancer Institute | Vilnius | LT-08660 | Lithuania |
| Vilnius University Hospital Santaros Clinic | Vilnius | LT-08661 | Lithuania |
| Teverelix TFA 180 mg 6-weekly |
Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Testosterone (T) Levels (0.2 ng/mL) at Week 4 | Proportion of participants achieving castration level with serum T <0.2 ng/mL at Day 28 | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Testosterone (T) Levels (Castrate) at Week 6 | Proportion of participants achieving castration level with serum T <0.5 ng/mL at Day 42 | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Testosterone (T) Levels (0.2 ng/mL) at Week 6 | Proportion of participants achieving profound castration level (0.2 ng/mL) with serum T <0.5 ng/mL at Day 42 | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Testosterone Levels (Castrate) at Week 24 | Proportion of participants achieving a T castration rate over 168 days of treatment period | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Testosterone Levels (0.2 ng/mL) at Week 24 | Proportion of participants achieving profound castration rate (<0.2 ng/mL) over 168 days of treatment period | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Time to Achieve Castrate Levels of Testosterone (T) | Mean time to T levels falling below castration level (<0.5 ng/mL) for the first time | Posted | Median | 95% Confidence Interval | days | 4 weeks |
|
|
|
| Secondary | Time to Escape Castrate Levels of Testosterone (T) | Mean time to (first) overstep of T castration level after achieving castration | Posted | Median | 95% Confidence Interval | days | Approximately 30 weeks |
|
|
|
| Secondary | Luteinizing Hormone (LH) Levels (Castrate) at Week 4 | Proportion of participants achieving castration level for LH (LH <1.1 U/L) at Day 28 | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Luteinizing Hormone (LH) Levels (Castrate) at Week 24 | Proportion of participants with effective LH castration rate over 168 days of treatment period | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Time to Achieve Castrate Levels of Luteinizing Hormone (LH) | Mean time to LH levels falling below castration level (LH <1.1 U/L) for the first time | Posted | Median | 95% Confidence Interval | days | 4 weeks |
|
|
|
| Secondary | Time to Escape Castrate Levels of Luteinizing Hormone (LH) | Mean time to (first) overstep of LH castration level after achieving castration | Posted | Median | 95% Confidence Interval | days | 24 weeks |
|
|
|
| Secondary | Change in Testosterone Levels Over Time (Change From Baseline at Day 168) | The change in testosterone levels over time (Change from Baseline at Day 168) | Per Protocol | Posted | Mean | Standard Deviation | nmol/L | 24 weeks |
|
|
|
| Secondary | Change in LH Levels Over Time | The change in LH levels over time | Per Protocol | Posted | Mean | Standard Deviation | IU/L | 24 weeks |
|
|
|
| Secondary | Change in FSH Levels Over Time | The change in FSH levels over time | Per Protocol | Posted | Mean | Standard Deviation | IU/L | 24 weeks |
|
|
|
| Secondary | Area Under the Concentration Time-curve From Time Zero up to the Last Quantifiable Concentration at Time Point t (AUC0-t) | Area under the concentration time-curve from time zero up to the last quantifiable concentration at time point t (Ct), calculated using the linear up/log down trapezoidal rule. | Per Protocol | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 24 weeks |
|
|
|
| Secondary | Area Under the Concentration Time-curve From Time Zero up to the Concentration at Time Point t1 After Which the Concentrations Start to Rise Again Towards a Second Peak (AUC0-t1) | Area under the concentration time-curve from time zero up to the concentration at time point t1 after which the concentrations start to rise again towards a second peak, calculated using the linear up/log down trapezoidal rule. t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC). | Per Protocol | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 24 weeks |
|
|
|
| Secondary | Maximum Observed Plasma Teverelix Concentration After Administration (Cmax) | The maximum observed plasma teverelix concentration after administration (Cmax) | Per Protocol | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 24 weeks |
|
|
|
| Secondary | Maximum Observed Concentration After Administration From Zero up to Time Point t1 (Cmax,0-t1) | The maximum observed concentration after administration from zero up to time point t1 (Cmax,0-t1) | Per Protocol | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 24 weeks |
|
|
|
| Secondary | Maximum Observed Concentration After Administration From Time Point t1 up to Time Point t (Cmax,t1-t) | The maximum observed concentration after administration from time point t1 up to time point t (Cmax,t1-t) | Per Protocol | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 24 weeks |
|
|
|
| Secondary | Time to Reach Cmax After Dosing (Tmax) | The time to reach Cmax after dosing (tmax) | Per Protocol | Posted | Median | Full Range | hours | 24 weeks |
|
|
|
| Secondary | Time to Reach Cmax,0-t1 After Dosing (Tmax,0-t1) | The time to reach Cmax,0-t1 after dosing (tmax,0-t1) | Per Protocol | Posted | Median | Full Range | hours | 24 weeks |
|
|
|
| Secondary | Time to Reach Cmax,t1-t After Dosing (Tmax,t1-t) | The time to reach Cmax,t1-t after dosing (tmax,t1-t) | Per Protocol | Posted | Median | Full Range | hours | 24 weeks |
|
|
|
| Secondary | Apparent Terminal Elimination Rate Constant (Lambda-z) | The apparent terminal elimination rate constant (lambda-z) | Per Protocol | Posted | Geometric Mean | 95% Confidence Interval | L/h | 24 weeks |
|
|
|
| Secondary | Apparent Terminal Plasma Half-life (t½) | Apparent terminal plasma half-life, calculated as: ln 2 / lambda-z | Per Protocol | Posted | Median | Full Range | hours | 24 weeks |
|
|
|
| Secondary | Area Under the Concentration Time-curve From Time Zero up to Infinity (∞)(AUC0-∞) | Area under the concentration time-curve from time zero up to infinity (∞),calculated using the linear up/log down trapezoidal rule. | Per Protocol | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 24 weeks |
|
|
|
| Secondary | Prostate Specific Antigen (PSA) Reduction (≥50 Percent) | Number of participants with a PSA response of ≥50 percent reduction at the Day 168 visit | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | PSA Response Rate at Day 28 | PSA response is defined as >50% decline in PSA at Day 28. PSA response rate is the number of subjects with a PSA response. | Per Protocol | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | PSA Response ≥50% at Day 168 | The number of subjects with a PSA response ≥50% at Day 168 | Per Protocol | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Luteinizing Hormone (LH) Mean % Reduction at Day 168 | Luteinizing Hormone (LH) - the mean % reduction at Day 168 | Per Protocol | Posted | Mean | Standard Deviation | % of baseline value | 24 weeks |
|
|
|
| Secondary | Testosterone (T) Mean % Reduction at Day 168 | Testosterone (T) - the mean % reduction at Day 168 | Per Protocol | Posted | Mean | Standard Deviation | % of baseline | 24 weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone (FSH) Mean % Reduction at Day 168 | Follicle Stimulating Hormone (FSH) - the mean % reduction at Day 168 | Per Protocol | Posted | Mean | Standard Deviation | % of baseline | 24 weeks |
|
|
|
| Secondary | Treatment-emergent Adverse Events (AEs) | Number of participants with treatment-emergent AEs | Safety Population | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | ECG QTcF Interval Prolongation >450 Msec at Day 28 | ECG QTcF Interval prolongation >450 msec at Day 28 study visit | Safety Population | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Injection Site Reactions (ISRs) | Number of participants with ISRs at each visit during the 168 days treatment period | Safety Population | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 8 |
| 9 |
| EG001 | Teverelix TFA 180 mg 6-weekly | Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24 teverelix TFA 180 mg: Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24 | 1 | 41 | 1 | 41 | 38 | 41 |
|
| benign pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | Study drug was discontinued as exclusion criterion was met. |
|
| cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | A 75 year old, in Group 2, had a cardiac arrest on Day 196 during follow-up period of the study and subsequently died. |
|
| Injection site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract stoma complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nephrostomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
| D052801 |
| Male Urogenital Diseases |