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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01511 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The goal of this clinical research study is to learn if the combination of 3 drugs (gemcitabine, capecitabine, and bevacizumab) can help to control metastatic or unresectable renal cell carcinoma. The safety of this drug combination will also be tested.
Gemcitabine and capecitabine are designed to disrupt the growth of cancer cells, which may cause cancer cells to start to die. Bevacizumab is a drug that binds to and inhibits Vascular Endothelial Growth Factor (VEGF), a blood-vessel stimulating agent with unusually high levels in kidney cancer.
If you are found to be eligible to take part in this study, you will receive gemcitabine, capecitabine, and bevacizumab on a 28 day cycle. Capecitabine will be taken by mouth (with food), twice daily, on Days 1-21. Gemcitabine will be given through a needle in your vein in your arm over 30 minutes on Days 1 and 15. Bevacizumab will be given through a needle in your vein in your arm on Days 1 and 15. It will be given over 120 minutes for Cycle 1 and over 60 minutes for all other cycles. Your doctor may decided to give you bevacizumab over 30 minutes if you tolerate the treatment well.
On the first day of each cycle, blood (about 2 teaspoons) and a urine will be collected before treatment for routine tests. You will also have blood drawn on Day 15 (about 2 teaspoons) for routine tests.
Every 8 weeks, you will have a CT scan of your chest, abdomen, and pelvis and a chest x-ray. You will be asked about any drugs that you are currently taking and you will have a complete physical exam. You will be asked about any side effects that you might have experienced since the last visit and your ability to perform daily activities will be evaluated. Repeat bone scans and MRI of the brain may be done if your doctor thinks it is necessary.
You will continue receiving treatment for a maximum of 12 months. However, if you are benefitting from treatment, you may be able to continue receiving it off study. You will be taken off study if the disease gets worse, if the side effects are intolerable, or if you develop another illness that prevents you from receiving the treatment.
This is an investigational study. Gemcitabine, capecitabine, and bevacizumab are all FDA approved and commercially available. Up to 40 participants may take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine + Gemcitabine + Bevacizumab | Experimental | Capecitabine 800 mg/m^2 By Mouth Twice Daily On Days 1-21. Gemcitabine 900 mg/m^2 By Vein Over 30 Minutes on Days 1 and 15. Bevacizumab 10 mg/kg By Vein On Days 1 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | 800 mg/m^2 By Mouth Twice Daily On Days 1-21. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. | 12 months or until progression of disease |
| Time to Treatment Failure (TTF) | Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. | 12 months or until progression of disease |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nizar M. Tannir, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: July 2, 2007 to February 24, 2012. All recruitment done at The University of Texas Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine + Gemcitabine + Bevacizumab | Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine + Gemcitabine + Bevacizumab | Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15. |
| 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 | Progression Free Survival (PFS) | Event or disease-free survival given as progression free survival (PFS) which was defined as the length of time after primary treatment that the participant survives without disease progression. Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST) where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. | One participant was excluded from survival analysis due to missing data. | Posted | Median | 95% Confidence Interval | Months | 12 months or until progression of disease |
|
Adverse events were collected over 28 day cycle up to one year with 12 cycles administered.
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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 | Capecitabine + Gemcitabine + Bevacizumab | Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | sourceVocabulary | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nazir Tannir/ | The University of Texas MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Gemcitabine | Drug | 900 mg/m^2 By Vein Over 30 Minutes on Days 1 and 15. |
|
|
| Bevacizumab | Drug | 10 mg/kg By Vein On Days 1 and 15. |
|
|
| 12 months or until progression of disease |
| Death |
|
| Complications unrelated |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Time to Treatment Failure (TTF) | Time to treatment failure, TTF, with failure defined as death or disease progression where progression is defined per RECIST criteria as an increase in disease of 20% or more in the sum of longest tumor diameters compared to baseline. | Four participants were excluded from response analysis due to missing data. | Posted | Median | 95% Confidence Interval | Months | 12 months or until progression of disease |
|
|
|
| Secondary | Objective Response Rate (ORR) | Objective response defined as Complete Response + Partial Response, with response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete Response: The disappearance of all target lesions. Partial Response: >30% decrease in the sum of the longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since the treatment started. | Four participants were excluded from response analysis due to missing data. | Posted | Number | percentage of participants | 12 months or until progression of disease |
|
|
|
| 3 |
| 34 |
| 31 |
| 34 |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | including sneezing, nasal stuffiness, postnasal drip |
|
| Allergy/Immunology | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac General-Other | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cervical spine-range of motion | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constitutional Symptoms | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology/Skin-Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: head and neck | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: limb | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Endocrine | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Fever (in absence neutropenia, where neutropenia is defined as ANC <1.0 x 10^9 per liter) |
|
| Gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobinuria | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, GU--Select | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage/Bleeding | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes/flushes | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension (Adult) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension (Pediatric) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes (Total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphatics | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration (Anxiety) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration (Depression) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis (clinical exam) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis (clinical exam) (Oral Cavity) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis (functional/symptomatic) (Oral Cavity) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis (functional/symptomatic) (Stomach) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity - lower) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal/Soft Tissue-Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurology | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Obstruction, GI--Select (Small bowel NOS) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Abdomen NOS) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Back) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Extremity-limb) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Head/headache) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Neck) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Oral Cavity) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Oral-gums) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain--Select (Pelvis) | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Potassium serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PTT (Partial Thromboplastin Time) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory-Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal/Genitourinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Small/Large intestine | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia--Select (Sinus tachycardia) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating (diaphoresis) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urine color change | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Voice changes/dysarthria | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | e.g., hoarseness, loss or alteration in voice, laryngiti |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Watering eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |