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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00138918 | Other Identifier | University of Michigan |
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This clinical trial will determine whether the addition of radiotherapy to standard of care systemic therapy improves objective progression-free survival compared to systemic therapy alone in patients with oligometastatic castration-resistant prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. |
|
| Standard of Care + Ablative Radiation | Experimental | Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablative Radiation Therapy | Radiation | Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Duration of Response | Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. A patient's designated response at any one time is a combination of the assessment of target lesions, non-target lesions, bone lesions and disease symptoms. Progression in this measure is defined as worsened pain or new sites of disease on imaging. Progression by pain due to prostate cancer requires evidence of disease at the site of pain and one or more palliative intervention (opioid therapy for 10 out of 14 consecutive days, radionuclide therapy or radiation therapy). Response and progression definitions used will be a combination of the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1 and the Prostate Cancer Working Group 3. | At 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Objective Progression Free Survival (PFS) Time | PFS is defined as the duration of time from start of treatment to date of progression or death (whichever is first). Initiation of other prostate directed therapies (excluding bisphosphonates or RANKL inhibitors) is considered to be progression. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | At 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachery Reichert, MD, PhD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States | ||
| University of Michigan Cancer Center |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
| FG001 | Standard of Care + Ablative Radiation | Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
| 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 | Median Duration of Response | Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. A patient's designated response at any one time is a combination of the assessment of target lesions, non-target lesions, bone lesions and disease symptoms. Progression in this measure is defined as worsened pain or new sites of disease on imaging. Progression by pain due to prostate cancer requires evidence of disease at the site of pain and one or more palliative intervention (opioid therapy for 10 out of 14 consecutive days, radionuclide therapy or radiation therapy). Response and progression definitions used will be a combination of the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1 and the Prostate Cancer Working Group 3. | NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future | Posted | Median | Standard Deviation | months | At 12 Months |
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4 year and 7 month period for an average of 20 months per patient.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | CTCAE (4.03) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (4.03) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2021 | Oct 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2019 | Oct 2, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C540278 | enzalutamide |
| C089740 | abiraterone |
| D000077143 | Docetaxel |
| C552428 | cabazitaxel |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hormone therapy or chemotherapy | Drug | Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
|
|
| Median Prostate Specific Antigen (PSA) PFS | The Median PSA PFS is defined as the median duration of time from start of treatment to date that PSA progression is documented or death occurs (whichever is first). PSA progression is defined as a 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 2 ng/ml. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | At 24 months |
| Median Radiographic PFS | Radiographic PFS is defined as the duration of time from start of treatment to date that progression is radio-graphically documented or death occurs (whichever is first). Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | At 24 months |
| Overall Survival Time | Overall survival (OS) is defined as the duration of time from start of treatment to death. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | 24 months |
| Prostate Cancer Specific Survival Time | Prostate Cancer Specific Survival (PCSS) is defined as the duration of time from start of treatment to death from prostate cancer. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | 24 months |
| Non-irradiated Metastases Free Survival Time | Non-irradiated metastases free survival is defined as the duration of time from start of treatment to the date of progressive disease of a new target lesion, a new non-measurable/non-target lesion or emergence of 2 or more new skeletal lesions on a bone scan. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | At 24 months |
| The Proportion of Patients With Complete PSA Response | The number of patients whose PSA becomes undetectable (≤0.2 ng/ml) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with complete PSA response. Complete PSA response is defined as an undetectable PSA (≤0.2 ng/ml). | 24 months |
| The Proportion of Patients With a PSA Partial Response 50 (PR50) | The number of patients whose PSA declines by 50% decline (PSA partial response 50 (PR50)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR50. PR50 response is defined as a decrease in PSA value by ≥ 50%. | 24 months |
| The Proportion of Patients With a PSA Partial Response 90 (PR90) | The number of patients whose PSA declines by 90% decline (PSA partial response 90 (PR90)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR90. PR90 response is defined as a decrease in PSA value by ≥ 90%. | 24 months |
| The Proportion of Patients That Respond to Treatment | The measurable disease response rate (CR + PR) will be calculated for patients evaluable for measurable disease response. Complete response (CR) is defined as a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 mm. There can be no appearance of new lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. | 24 months |
| Patient-reported Outcome Based on NCCN-FACT FPSI-17 (Version 2) | The National Comprehensive Cancer Network Functional Assessment of Cancer Therapy - Prostate Symptom Index (NFPSI-17), version 2 is used to assess high priority symptoms/QOL concerns in patients with advanced prostate cancer (PC). It is a 17-item survey with a recall period of the past 7 days; scored using a 5 point Likert-type scale. Items are scored from 1-4 with some items reverse scored. Described using means or medians. score range is 0-68 with higher scores indicating better health | measured at 6 and 12 months post starting treatment |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG001 | Standard of Care + Ablative Radiation | Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
| 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 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Standard of Care | Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
| OG001 | Standard of Care + Ablative Radiation | Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. |
|
|
| Secondary | Median Objective Progression Free Survival (PFS) Time | PFS is defined as the duration of time from start of treatment to date of progression or death (whichever is first). Initiation of other prostate directed therapies (excluding bisphosphonates or RANKL inhibitors) is considered to be progression. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | Posted | Median | 95% Confidence Interval | Months | At 24 months |
|
|
|
| Secondary | Median Prostate Specific Antigen (PSA) PFS | The Median PSA PFS is defined as the median duration of time from start of treatment to date that PSA progression is documented or death occurs (whichever is first). PSA progression is defined as a 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 2 ng/ml. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | Posted | Median | 95% Confidence Interval | months | At 24 months |
|
|
|
| Secondary | Median Radiographic PFS | Radiographic PFS is defined as the duration of time from start of treatment to date that progression is radio-graphically documented or death occurs (whichever is first). Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | Posted | Median | 95% Confidence Interval | Months | At 24 months |
|
|
|
| Secondary | Overall Survival Time | Overall survival (OS) is defined as the duration of time from start of treatment to death. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
|
|
| Secondary | Prostate Cancer Specific Survival Time | Prostate Cancer Specific Survival (PCSS) is defined as the duration of time from start of treatment to death from prostate cancer. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future | Posted | Median | Full Range | days | 24 months |
|
|
|
| Secondary | Non-irradiated Metastases Free Survival Time | Non-irradiated metastases free survival is defined as the duration of time from start of treatment to the date of progressive disease of a new target lesion, a new non-measurable/non-target lesion or emergence of 2 or more new skeletal lesions on a bone scan. Reported as Kaplan-Meier estimates, including median at 12 months and 24 month. | NA- Per biostatistician, values must be reported as NA due to lack of data from insufficient number of participants with events. Data is not available now nor will it be available in the future | Posted | Median | Full Range | days | At 24 months |
|
|
|
| Secondary | The Proportion of Patients With Complete PSA Response | The number of patients whose PSA becomes undetectable (≤0.2 ng/ml) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with complete PSA response. Complete PSA response is defined as an undetectable PSA (≤0.2 ng/ml). | Posted | Number | 95% Confidence Interval | percentage of patients | 24 months |
|
|
|
| Secondary | The Proportion of Patients With a PSA Partial Response 50 (PR50) | The number of patients whose PSA declines by 50% decline (PSA partial response 50 (PR50)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR50. PR50 response is defined as a decrease in PSA value by ≥ 50%. | Posted | Number | 95% Confidence Interval | percentage of patients | 24 months |
|
|
|
| Secondary | The Proportion of Patients With a PSA Partial Response 90 (PR90) | The number of patients whose PSA declines by 90% decline (PSA partial response 90 (PR90)) will be counted in each treatment arm and divided by the number of patients who received any protocol treatment to provide the proportion of patients with PR90. PR90 response is defined as a decrease in PSA value by ≥ 90%. | Posted | Number | 95% Confidence Interval | percentage of patients | 24 months |
|
|
|
| Secondary | The Proportion of Patients That Respond to Treatment | The measurable disease response rate (CR + PR) will be calculated for patients evaluable for measurable disease response. Complete response (CR) is defined as a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 mm. There can be no appearance of new lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. | Posted | Number | 95% Confidence Interval | percentage of patients | 24 months |
|
|
|
| Secondary | Patient-reported Outcome Based on NCCN-FACT FPSI-17 (Version 2) | The National Comprehensive Cancer Network Functional Assessment of Cancer Therapy - Prostate Symptom Index (NFPSI-17), version 2 is used to assess high priority symptoms/QOL concerns in patients with advanced prostate cancer (PC). It is a 17-item survey with a recall period of the past 7 days; scored using a 5 point Likert-type scale. Items are scored from 1-4 with some items reverse scored. Described using means or medians. score range is 0-68 with higher scores indicating better health | score range is 0-68 with higher scores indicating better health | Posted | Mean | 95% Confidence Interval | score on a scale | measured at 6 and 12 months post starting treatment |
|
|
|
| 2 |
| 9 |
| 3 |
| 9 |
| 9 |
| 9 |
| EG001 | Standard of Care + Ablative Radiation | Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol. Ablative Radiation Therapy: Radiotherapy will typically be delivered to a total EQD2 (Equivalent dose in 2Gy fractions) that ranges between conventional 30 Gy in 10 fractions, to SBRT (Stereotactic Body Radiation Therapy) with 50 Gy in 5 fractions. Hormone therapy or chemotherapy: Current standard of care dosing with standard agents; hormone therapy or chemotherapy. | 2 | 5 | 0 | 5 | 5 | 5 |
| Fatigue | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.03) | Non-systematic Assessment | Leukemia |
|
| Stroke | Nervous system disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.03) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.03) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Fall | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.03) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Headache | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.03) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Pain in extremity | General disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.03) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.03) | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.03) | Non-systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (4.03) | Non-systematic Assessment | oral thrush |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Non-systematic Assessment | lacerations from fall |
|
| Immune system disorders - Other, specify | Immune system disorders | CTCAE (4.03) | Non-systematic Assessment | Enlarged cervical LN |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.03) | Non-systematic Assessment | Chronic myeloid leukemia |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Non-systematic Assessment | bilateral lower extremity cramping |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |