Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HSC-MS-14-0424 | Other Identifier | UTHSC-H CPHS (IRB) |
Not provided
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slow enrollment; resource re-allocation
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This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.
This is an open-label, single-arm study of neoadjuvant ADT and chemotherapy in subjects with non-metastatic, locally-advanced prostate cancer who are eligible for radical prostatectomy.
Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy. Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.
The primary endpoint will be complete or near-complete pathologic response.
Safety will be assessed on any patient receiving at least one dose of study drug by the reporting of adverse events, vital signs and by the assessment of findings on physical exam and routine safety laboratory determinations. The severity of adverse events and certain abnormal laboratory findings will be assessed according to the NCI CTCAE V4.03.
Laboratory-based studies will evaluate the following:
Complete metabolic profile
o BUN, creatinine, alkaline phosphatase, ALT/AST, total bilirubin, LDH, calcium, albumin, glucose, magnesium, uric acid, phosphorous
Electrolytes
o Sodium, potassium, chloride, CO2 content
Hematology
Testosterone
Biomarkers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADT + chemotherapy | Other | Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | Subcutaneous injection, once/month for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Measured by Pathologic Response | Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate. | Day of prostate removal, which is about 5 months following the day participant signed consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | baseline |
Not provided
Inclusion Criteria:
Pathologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3. No neuroendocrine differentiation or small cell features.
Recent (<6 weeks prior to study entry) negative bone scan and CT of the chest and abdomen.
Appropriate surgical candidate for radical prostatectomy and a performance status of <2 (ECOG scale).
Adequate bone marrow function as defined as an absolute peripheral granulocyte count >1500 and platelet count >100,000.
Adequate hepatic function per the following criteria:
Adequate renal function per the following criteria:
o Serum creatinine ≤1.5 x ULN
Normal coagulation profile (INR ≤ 1.5, aPTT ≤ 1.5 x ULN for the lab) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
Age ≥ 18 years
Written informed consent to participate in this study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Amato, D.O. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHealth Memorial Hermann Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADT + Chemotherapy | Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ADT + Chemotherapy | Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Efficacy as Measured by Pathologic Response | Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate. | Posted | Median | Full Range | percentage of tumor burden remaining | Day of prostate removal, which is about 5 months following the day participant signed consent. |
|
From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months.
Not provided
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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 | ADT + Chemotherapy | Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WATERY EYES | Eye disorders | CTCAE Ver 4.03 | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed and limited data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marka Lyons, Research Manager | The University of Texas Health Science Center at Houston | 713-500-6919 | Marka.Lyons@uth.tmc.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 | Jan 21, 2016 | Oct 9, 2018 | Prot_SAP_000.pdf |
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 |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| D004317 | Doxorubicin |
| D007654 | Ketoconazole |
| D000077143 | Docetaxel |
| D004961 | Estramustine |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Doxorubicin | Drug | 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 |
|
|
| Ketoconazole | Drug | 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 |
|
|
| Docetaxel | Drug | 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 |
|
|
| Estramustine | Drug | 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6 |
|
|
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy) |
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy) |
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Day 133, about 19 weeks after treatment initiation (but before prostatectomy) |
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | about 20 weeks after treatment initiation (day of prostatectomy) |
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | about 32 weeks after treatment initiation (about 12 weeks after prostatectomy) |
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | about 44 weeks after treatment initiation (about 24 weeks after prostatectomy) |
| Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | about 68 weeks after treatment initiation (about 48 weeks after prostatectomy) |
| Efficacy as Measured by Circulating Tumor Cell (CTC) Numbers | From the time the participant signs the informed consent until prostatectomy, an average of 5 months. |
| Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI) | The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging. | baseline |
| Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI) | The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging. | post treatment but prior to prostatectomy (about 25 days after the end of treatment) |
| Safety of Drug Regimen as Measured by Number of Adverse Events | Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy. | From the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy. |
| Surgical Morbidity as Measured by Number of Adverse Events | Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until the participant was taken off-study or the study was stopped, an average of 20 months | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ECOG Performance Status | The Eastern Cooperative Oncology Group (ECOG) Performance Status scale measures level of functioning. The scale ranges from 0 to 5, with 0 indicating the highest level of functioning and 5 the lowest. | Count of Participants | Participants |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | baseline |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy) |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy) |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | Day 133, about 19 weeks after treatment initiation (but before prostatectomy) |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | about 20 weeks after treatment initiation (day of prostatectomy) |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | Posted | Median | Full Range | ng/mL | about 32 weeks after treatment initiation (about 12 weeks after prostatectomy) |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | This data was only collected for 3 out of the 4 participants. | Posted | Median | Full Range | ng/mL | about 44 weeks after treatment initiation (about 24 weeks after prostatectomy) |
|
|
|
| Secondary | Efficacy as Measured by Prostate-specific Antigen (PSA) Levels | Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood. | This data was collected for only 3 out of the 4 participants. | Posted | Median | Full Range | ng/mL | about 68 weeks after treatment initiation (about 48 weeks after prostatectomy) |
|
|
|
| Secondary | Efficacy as Measured by Circulating Tumor Cell (CTC) Numbers | This data was not collected for any participants. | Posted | From the time the participant signs the informed consent until prostatectomy, an average of 5 months. |
|
|
| Secondary | Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI) | The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging. | Posted | Median | Full Range | cc | baseline |
|
|
|
| Secondary | Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI) | The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging. | Posted | Median | Full Range | cc | post treatment but prior to prostatectomy (about 25 days after the end of treatment) |
|
|
|
| Secondary | Safety of Drug Regimen as Measured by Number of Adverse Events | Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy. | Posted | Number | adverse event | From the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy. |
|
|
|
| Secondary | Surgical Morbidity as Measured by Number of Adverse Events | Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until the participant was taken off-study or the study was stopped, an average of 20 months | Posted | Number | adverse event | From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| BLOATING | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| GASTROESOPHAGEAL REFLUX | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| BACK PAIN | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| EDEMA LIMBS | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| FLU LIKE SYMPTOM-ACHINESS | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| MALAISE | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| PAIN | General disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| INFECTIONS/INFESTATIONS, THRUSH | Infections and infestations | CTCAE Ver 4.03 | Systematic Assessment |
|
| BRUISING - PORT A CATH SITE | Injury, poisoning and procedural complications | CTCAE Ver 4.03 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAE Ver 4.03 | Systematic Assessment |
|
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| MUSCULOSKELETAL/CONNECTIVE TISSUE DISORDERS, MUSCLE ACHES | Musculoskeletal and connective tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| COGNITIVE DISTURBANCE | Nervous system disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| AGITATION | Psychiatric disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| PSYCHIATRIC DISORDER, EMOTIONAL | Psychiatric disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| RESTLESSNESS | Psychiatric disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| BREAST PAIN | Reproductive system and breast disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| HICCUPS | Respiratory, thoracic and mediastinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| POST NASAL DRIP | Respiratory, thoracic and mediastinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| SNEEZING | Respiratory, thoracic and mediastinal disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| BULLOUS DERMATITIS | Skin and subcutaneous tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| NAIL DISCOLORATION | Skin and subcutaneous tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| SKIN/SQ TISSUE DISORDERS, PEELING OF SKIN AT PORT A CATH SITE | Skin and subcutaneous tissue disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| FLUSHING | Vascular disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| HOT FLASHES | Vascular disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| PSYCHIATRIC DISORDER, ANGER | Psychiatric disorders | CTCAE Ver 4.03 | Systematic Assessment |
|
| SKIN/SQ TISSUE DISORDERS, RIGHT HAND SKIN IRRITATION | Skin and subcutaneous tissue disorders | CTCAE Ver 4.03 | 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |