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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1128-6861 | Registry Identifier | WHO | |
| JapicCTI-121763 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP-144-SR(6M) | Experimental | TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks. |
|
| TAP-144-SR(3M) | Active Comparator | TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP-144-SR(6M) | Drug |
| ||
| TAP-144-SR(3M) |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Suppression of Serum Testosterone to Castrate Level | Comparison of the proportion of patients maintained at castration level (≤100 ng/dL) | From the start of study drug administration through Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Time Course of Changes in Serum Testosterone | From baseline to Week 48 | |
| Time Course of Changes in Serum Luteinizing Hormone (LH) | From baseline to Week 48 | |
| Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) |
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Inclusion Criteria:
(1) Renal function: serum creatinine level< 1.5 times the upper limit of normal (ULN) (2) Bone-marrow function: white blood count ≥ 3,500/ mm3, platelet count ≥ 100,000/L, hemoglobin ≥ 10.0g/dL (3) Hepatic function: AST(GOT), ALT(GPT), ALP and total bilirubin ≤ 2.5 times the ULN 10. The participant's life expectancy is at least 24 months at informed consent.
Exclusion Criteria:
(1) Radiotherapy. As for I-125 brachytherapy, within 35 weeks (245 days) prior to study enrollment.
(2) Prostatectomy (3) Experimental therapy including high-intensity focused ultrasound therapy (HIFU), immunotherapy, and gene therapy 11. Patients who received the following drugs within 4 weeks (28 days) before starting the study drug: Testosterones, ketoconazole(except for external preparations), spironolactone, corticosteroids (excluding their inhalants and external preparations), and Chinese medicines and dietary supplements containing saw palmetto 12. Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening 13. The participant has a history of hypersensitivity to synthetic LHRH, LHRH derivative or any component of the study drug.
14. The participant has central nervous system metastasis which requires treatment or which is symptomatic.
15. The participant already has a history or has a complication or may have renal disorder caused by spinal cord compression or ureteric obstruction.
16. The participant has a history of serious drug allergic reaction/hypersensitivity 17. The participant has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
Prostate cancer patients previously treated with hormonal therapy were enrolled in 1 of 2 treatment groups. Two patients withdrew from the period between randomization and starting study drugs (1 in TAP-144-SR(6M) arm and 1 in TAP-144-SR(3M) arm).
Participants took part in the study at 23 investigative sites in Japan from 11 April 2012 to 04 April 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAP-144-SR(6M) | TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks. |
| FG001 | TAP-144-SR(3M) | TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From baseline to Week 48 |
| Time Course of Change Rate in Serum PSA (FAS) | Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen [PSA]) | From baseline to Week 48 |
| The Maximum Rate of Change in PSA Suppression (FAS) | Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA) | From baseline to Week 48 |
| Percentage of Participants With Progression by PSA (FAS) | Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA) | From baseline to Week 48 |
| Soft Tissue Response | Assessment in accordance with the "criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | At week 48 |
| Bone Lesion Response | Partially revised assessment based on the "criteria for therapeutic effect" from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression | At Week 48 |
| Serum Unchanged TAP-144 Level | From baseline to Week 48 |
| 12-lead ECG | At 1 hour, week 24, and week 48 after administration |
| Chiba |
| Chiba |
| Japan |
| Fukuoka | Fukuoka | Japan |
| Maebashi | Gunma | Japan |
| Sapporo | Hokkaido | Japan |
| Kanazawa | Ishikawa-ken | Japan |
| Yokohama | Kanagawa | Japan |
| Sendai | Miyagi | Japan |
| Nigata-shi | Niigata | Japan |
| Osaka | Osaka | Japan |
| Suita-shi | Osaka | Japan |
| Ageo-shi | Saitama | Japan |
| Kita-adachi-gun | Saitama | Japan |
| Shizuoka | Shizuoka | Japan |
| Itabashi-ku | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Received Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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The population included all participants who were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAP-144-SR(6M) | TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks. |
| BG001 | TAP-144-SR(3M) | TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Gleason Score | Gleason score is a score used in prostate cancer grading. Prostate cancer staging is the process by which physicians categorize the risk of cancer having spread beyond the prostate, or equivalently, the probability of being cured with local therapies such as surgery or radiation. Gleason score are often grouped into four stages (I-IV) of prostate cancer. Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors. | Number | Participants |
| |||||||||||||||
| Tumor-node-metastasis (TNM) classification at diagnosis: T | Number of participants for whom TNM classification at diagnosis: T data is available in the TAP-144-SR(3M) treatment arm is 79, respectively. The categories of T is ranged from T1 (better) to T4 (worse). Tx represents "tumor cannot be evaluated" and T0 represents "no signs of tumor." | Number | Participants |
| |||||||||||||||
| TNM classification at diagnosis: N | Number of participants for whom TNM classification at diagnosis: N data is available in the TAP-144-SR(3M) treatment arm is 79, respectively. The categories of N is represented by Nx (lymph nodes cannot be evaluated), N0 (tumor cells absent from regional lymph nodes), and N1 (regional lymph node metastasis present). | Number | Participant |
| |||||||||||||||
| TNM classification at diagnosis: M | Number of participants for whom TNM classification at diagnosis: M data is available in the TAP-144-SR(3M) treatment arm is 79, respectively. The categories of M is represented by M0 (no distant metastasis), and M1 (metastasis to distant organs (beyond regional lymph nodes). | Number | participants |
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| Period between date of first dianosis and date of informed consent | Mean | Standard Deviation | Years |
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| Period between first dose dates of leuproride acetate (over-the-counter) and the study drug | Mean | Standard Deviation | Weeks |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Number of participants for whom ECOG Performance Status data is available in Baseline Characteristics is 81 and 79 in each treatment arm, respectively. The categories of ECOG Performance Status is represented from 0 (Fully active, better) to 4 (Completely disabled, worse). | Number | Participants |
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| 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 | The Rate of Suppression of Serum Testosterone to Castrate Level | Comparison of the proportion of patients maintained at castration level (≤100 ng/dL) | Full analysis set participants (all randomized participants who received at least 1 dose of study drug) was used. | Posted | Number | Participants | From the start of study drug administration through Week 48 |
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|
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| Secondary | Time Course of Changes in Serum Testosterone | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Median | Full Range | ng/dL | From baseline to Week 48 |
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| Secondary | Time Course of Changes in Serum Luteinizing Hormone (LH) | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Median | Full Range | mIU/mL | From baseline to Week 48 | participants | Participants |
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| Secondary | Time Course of Changes in Serum Follicle-stimulating Hormone (FSH) | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Median | Full Range | mIU/mL | From baseline to Week 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time Course of Change Rate in Serum PSA (FAS) | Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen [PSA]) | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Median | Full Range | percent change | From baseline to Week 48 |
|
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| Secondary | The Maximum Rate of Change in PSA Suppression (FAS) | Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA) | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Median | Full Range | percent change | From baseline to Week 48 |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progression by PSA (FAS) | Evaluation according to the "Criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA) | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Number | percentage of participants | From baseline to Week 48 | Participants | Participants |
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| Secondary | Soft Tissue Response | Assessment in accordance with the "criteria for therapeutic effect" from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Number | Percentage of participants | At week 48 |
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| Secondary | Bone Lesion Response | Partially revised assessment based on the "criteria for therapeutic effect" from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Number | Percentage of participants | At Week 48 |
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| Secondary | Serum Unchanged TAP-144 Level | Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used. | Posted | Mean | Standard Deviation | ng/dL | From baseline to Week 48 |
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| Secondary | 12-lead ECG | Safety evaluation was conducted in the safety analysis set (SAS), which includes all 160 patients who received the study drug [TAP-144-SR (&M) group: 81 patients, TAP-144-SR (3M) group: 79 patients](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | msec | At 1 hour, week 24, and week 48 after administration |
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From the first dose of study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open-label study drug (up to 56 weeks).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 | TAP-144-SR(6M) | TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks. | 10 | 81 | 74 | 81 | ||
| EG001 | TAP-144-SR(3M) | TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks. | 8 | 79 | 71 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dementia with Lewy bodies | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Disuse syndrome | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site induration | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition 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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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | 800-778-2860 | trialdisclosures@takeda.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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| Male |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
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| 8 |
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| 9 |
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| 10 |
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| T1 |
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| T2 |
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| T3 |
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| T4 |
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| TX |
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| Unknown |
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| N1 |
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| NX |
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| Unknown |
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| M1 |
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| Unknown |
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| 1 |
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| 2 |
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| 3 |
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| 4 |
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