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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01372 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Slow Accrual
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This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers.
PRIMARY OBJECTIVES:
I. To assess changes in the levels of total- and free- prostate-specific antigen (PSA), free to total PSA (f/tPSA) ratio and insulin-like growth factor 1 (IGF-I) levels and IGF-I/free PSA (fPSA) ratio, insulin-like growth factor binding protein 3 (IGFBP-3), and vascular endothelial growth factor (VEGF) after Sunphenon 90DCF-T (green tea extract) supplementation during the period between recruitment and biopsy.
SECONDARY OBJECTIVES:
I. To evaluate the effects of oral ingestion on Sunphenon 90DCF-T supplementation during the period between recruitment and biopsy in the reactivation of glutathione S-transferase pi 1 (GSTP1) (whole blood deoxyribonucleic acid [DNA]); levels of antigen identified by monoclonal antibody Ki-67 (Ki-67), cluster of differentiation 34 (CD34), and M30 apopotosense in the prostate tissue.
II. To evaluate the effects of oral ingestion of Sunphenon 90DCF-T during the period between recruitment and biopsy on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture and quality of life (QOL) assessment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients undergo active surveillance for 52 weeks.
ARM B: Patients receive green tea extract orally (PO) once daily (QD) for 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (active surveillance) | Active Comparator | Patients undergo active surveillance for 52 weeks. |
|
| Arm B (Sunphenon) | Experimental | Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active surveillance | Other | Undergo active surveillance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total-PSA (tPSA) Levels | tPSA serum levels | From baseline at 52 weeks |
| Changes in the f/tPSA Ratio | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | From baseline at 52 weeks |
| Changes in IGF-I Levels | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Baseline to 52 weeks |
| Changes in the IGF-I/fPSA Ratio | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Baseline up to 52 weeks |
| Changes in the Level of IGFBP-3 | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Baseline to 52 weeks |
| Changes in the Level of VEGF | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Baseline up to 52 weeks |
| Changes in the Levels of Free-PSA (f-PSA) | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA) | The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA). | Up to 52 weeks |
| Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67 |
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Inclusion Criteria:
Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis
Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA ≤ 10, Gleason ≤ 6 at the time of initial diagnosis. As the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA ≤10 and Gleason ≤6 for a patient who has had no treatment, will not render the patient ineligible. If the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA≤10 and Gleason ≤6, the patient is eligible
Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Advodart, and anti-inflammatory agents
Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol
Willing and able to take oral medications
Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea for the duration of the study
Subjects must have newly diagnosed (within 1 year), previously untreated prostate cancer without other malignancy; therefore, no prior therapies are permitted
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ institutional upper limit of normal
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ institutional upper limit of normal
Serum creatinine within normal institutional limits
Subject must be willing to limit alcohol to moderate use which is defined as: up to one drink a day for women or two drinks a day for men; examples of one drink include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Ponsky, MD | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Active Surveillance) | Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| FG001 | Arm B (Sunphenon) | Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Active Surveillance) | Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| BG001 | Arm B (Sunphenon) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Total-PSA (tPSA) Levels | tPSA serum levels | Participants with available PSA values | Posted | Mean | Standard Deviation | ng/mL | From baseline at 52 weeks |
|
30 days after 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 | Arm A (Active Surveillance) | Patients undergo active surveillance for 52 weeks. active surveillance: Undergo active surveillance laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Ponsky | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | +1 216-844-4831 | lee.ponsky@uhhospitals.org |
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| 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 |
|---|---|
| D057832 | Watchful Waiting |
| C074269 | Sunphenon |
| D013662 | Tea |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Sunphenon |
| Drug |
Given PO |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Questionnaire Administration | Other | Ancillary studies |
|
|
| from baseline at 52 weeks |
The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA. |
| Up to 52 weeks |
| Effects of Oral Ingestion of Green Tea Extract on Levels of CD34 | The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA. | Up to 52 weeks |
| Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue | The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA. | Up to 52 weeks |
| Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture | Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture | Up to 52 weeks |
| Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores | Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Baseline |
| Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores | Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | At 24 weeks |
| Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores | Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | at 3.5 years from start of study |
| Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) | Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health. | Baseline |
| Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) | Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health. | At 24 weeks |
| Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) | Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health. | At 3.5 years from start of study |
| Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) | Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment. | Baseline |
| Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) | Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment. | At 24 weeks |
| Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) | Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment. | At 3.5 years from start of study |
| Sexual Health Inventory in Men Score (SHIM Score) | SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows: 22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction Reported values are an average of three collected data points per participant: at baseline, at 24 weeks, and at end of study (3.5 years) | Baseline, at 24 weeks, and at 3.5 years from start of study |
Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Changes in the f/tPSA Ratio | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Participants with available PSA values | Posted | Mean | Standard Deviation | ratio | From baseline at 52 weeks |
|
|
|
| Primary | Changes in IGF-I Levels | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Posted | Mean | Standard Deviation | ng/mL | Baseline to 52 weeks |
|
|
|
| Primary | Changes in the IGF-I/fPSA Ratio | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Posted | Mean | Standard Deviation | ratio | Baseline up to 52 weeks |
|
|
|
| Primary | Changes in the Level of IGFBP-3 | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Posted | Mean | Standard Deviation | ng/mL | Baseline to 52 weeks |
|
|
|
| Primary | Changes in the Level of VEGF | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Posted | Mean | Standard Deviation | pg/mL | Baseline up to 52 weeks |
|
|
|
| Primary | Changes in the Levels of Free-PSA (f-PSA) | The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated. | Participants with available PSA values | Posted | Mean | Standard Deviation | ng/mL | from baseline at 52 weeks |
|
|
|
| Secondary | Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA) | The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA). | Posted | Mean | Standard Deviation | ng/mL | Up to 52 weeks |
|
|
|
| Secondary | Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67 | The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA. | ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed. | Posted | Up to 52 weeks |
|
|
| Secondary | Effects of Oral Ingestion of Green Tea Extract on Levels of CD34 | The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA. | ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed. | Posted | Up to 52 weeks |
|
|
| Secondary | Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue | The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA. | M30 levels could not be determined because there were no tumor cells in biopsy | Posted | Up to 52 weeks |
|
|
| Secondary | Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture | Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture | Could not be determined because there were no tumor cells in biopsy | Posted | Up to 52 weeks |
|
|
| Secondary | Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores | Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores | Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Posted | Mean | Standard Deviation | score on a scale | At 24 weeks |
|
|
|
| Secondary | Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores | Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Posted | Mean | Standard Deviation | score on a scale | at 3.5 years from start of study |
|
|
|
| Secondary | Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) | Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) | Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health. | Posted | Mean | Standard Deviation | score on a scale | At 24 weeks |
|
|
|
| Secondary | Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) | Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health. | Posted | Mean | Standard Deviation | score on a scale | At 3.5 years from start of study |
|
|
|
| Secondary | Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) | Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) | Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment. | Posted | Mean | Standard Deviation | score on a scale | At 24 weeks |
|
|
|
| Secondary | Urinary Symptoms as Assessed by Mean American Urological Association Symptom Index (AUA) | Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment. | Posted | Mean | Standard Deviation | score on a scale | At 3.5 years from start of study |
|
|
|
| Secondary | Sexual Health Inventory in Men Score (SHIM Score) | SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows: 22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction Reported values are an average of three collected data points per participant: at baseline, at 24 weeks, and at end of study (3.5 years) | Data were not collected | Posted | Baseline, at 24 weeks, and at 3.5 years from start of study |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Arm B (Sunphenon) | Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity. Sunphenon: Given PO laboratory biomarker analysis: Correlative studies Questionnaire Administration: Ancillary studies | 0 | 2 | 0 | 2 | 1 | 2 |
| Vertigo | Ear and labyrinth disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Bowel Function |
|
| Sexual Function |
|
| Hormonal Function |
|
| Bowel Function |
|
| Sexual Function |
|
| Hormonal Function |
|
| Bowel Function |
|
| Sexual Function |
|
| Hormonal Function |
|