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| ID | Type | Description | Link |
|---|---|---|---|
| NU 04S1 | Other Identifier | Northwestern University | |
| STU00006784 | Other Identifier | Northwestern University IRB |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with angiosarcoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 to 4 months for 2 years.
PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | Bevacizumab treatment until disease progression or intolerance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. | During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage). Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having 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. | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate in Patients Treated With Bevacizumab. | Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease, defined as having 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. |
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DISEASE CHARACTERISTICS:
Histologically confirmed angiosarcoma
Newly diagnosed or recurrent/refractory disease
No prior tumor-related hemorrhage (any grade)
Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
No CNS disease, brain metastases, or primary brain tumors
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Agulnik, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rebecca and John Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
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The study opened for accrual on June 1, 2005 with an accrual goal of up to 31 patients. The study was designed to enroll 12 patients initially and do an interim efficacy assessment. Accrual was suspended on February 28, 2007 for this analysis and reopened on May 15, 2007. Study was closed to accrual permanently on April 19, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Bevacizumab treatment until disease progression or intolerance Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Registered to Study |
| |||||||||||||
| Bevacizumab Treatment Cycles 1-2 |
| |||||||||||||
| First Response Assessment |
| |||||||||||||
| Continued Bevacizumab Cycle 3+ |
| |||||||||||||
| Follow up for Survival x 2 Years |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Bevacizumab treatment until disease progression or intolerance Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle). |
| 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 Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria. | During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage). Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having 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. | Posted | Median | 95% Confidence Interval | Weeks | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. |
|
Adverse events were collected over a 5 year period.
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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 | Bevacizumab | Bevacizumab treatment until disease progression or intolerance Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ( congestive heart failure) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Agulnik, MD | Northwestern University | 312-695-6182 | magulnik@nm.org |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D006394 | Hemangiosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D042461 | Vascular Endothelial Growth Factor A |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. |
| Duration of Response. | During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage). | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. |
| Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival | After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage). | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years |
| Evaluate the Toxicity of Bevacizumab. | Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years. |
| Chicago |
| Illinois |
| 60611-3013 |
| United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Fox Chase Cancer Center CCOP Research Base | Philadelphia | Pennsylvania | 19140 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
|
|
|
|
| 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 | Count of Participants | Participants | No |
|
| Type of Sarcoma | Count of Participants | Participants |
|
Bevacizumab treatment until disease progression or intolerance Bevacizumab: Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle). |
|
|
|
| Secondary | Objective Response Rate in Patients Treated With Bevacizumab. | Objective response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease, defined as having 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. | Posted | Count of Participants | Participants | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. |
|
|
|
| Secondary | Duration of Response. | During treatment, evaluation of response will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, evaluation of response will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage). | Data for this outcome measure was not collected. By the time the results of the study were being collected, this outcome measure was no longer relevant as Recist 1.0 was in use. As a result, data for this outcome measure was not collected or analysed. Time to progression was a more relevant data point. | Posted | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years. |
|
|
| Secondary | Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival | After Study drug completion, assessment of treatment effect of bevacizumab on duration of overall survival will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage). | Posted | Median | 95% Confidence Interval | Weeks | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years |
|
|
|
| Secondary | Evaluate the Toxicity of Bevacizumab. | Toxicity data for bevacizumab will be collected on day 1 of every cycle (1 cycle = 21 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Number of participants with either grade 1 (mild), 2 (moderate),3 (severe), 4 (life-threatening) adverse event related to treatment. | Posted | Number | participants | Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years. |
|
|
|
| Post-Hoc | Time to Progression | During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment , and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage) Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having 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. | Posted | Mean | Standard Deviation | Weeks | After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); ever 3-4 months after treatment up to 2 years |
|
|
|
| 14 |
| 30 |
| 8 |
| 30 |
| 30 |
| 30 |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Sinus infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Bladder infection (urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | resulting in a fall |
|
| Speech impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Episode of inability to speak |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain (non cardiac) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Knee surgery | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shot in leg | Social circumstances | CTCAE (3.0) | Systematic Assessment | Patient shot himself in the leg |
|
| Upper respiratory - bronchus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin (anemia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes (total white blood cells) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelet decrease | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia- atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Partial Thromboplastin Time (PTT) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ascites (non malignant) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis/stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| salivary gland changes (metallic taste) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| difficulty swallowing (dysphagia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nose bleed (Hemorrhage) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Colon infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Eye infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Edema (limbs) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Limb pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| High glucose (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| low glucose (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| High potassium (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| CNS cerebrovascularischemia - Transient ischemic attack | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | (Transient ischemic attack) |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shortness of breath (dyspnea) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Voice change/alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Watery eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urine color change | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flu-like syndrome | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGPT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Decline in FEV1 (forced expiratory volume) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dementia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment | Night sweats |
|
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D042442 | Vascular Endothelial Growth Factors |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Hypertension |
|
| Pain |
|
| Nausea |
|
| Infection |
|
| Headache |
|
| Anemia |
|
| Decline in FEV1 |
|
| Hyperglycemia |
|
| Transient ischemic attack |
|
| Neuromotor function |
|
| Cardiac (congestive heart failure) |
|
| Plural effusion |
|
| Liver-clinical |
|
| Anorexia |
|
| Fatigue |
|
| Alopecia |
|
| Dizziness |
|
| Edema |
|
| Dementia |
|
| Hemorrhage (epitasis) |
|