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| ID | Type | Description | Link |
|---|---|---|---|
| S9811 | Other Identifier | SWOG | |
| ECOG-S9811 | Other Identifier | ECOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eastern Cooperative Oncology Group | NETWORK |
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RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.
OBJECTIVES:
OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyurea | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydroxyurea | Drug | 20 mg/kg/day PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed). | Patients treated for 2 years or progression. If responding can continue at physician's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal | Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Lode J. Swinnen, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Geoffrey R. Barger, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks | Alaska | 99701 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Swinnen LJ, Rankin C, Rushing EJ, et al.: Phase II study of hydroxyurea for unresectable meningioma (Southwest Oncology Group S9811). [Abstract] J Clin Oncol 27 (Suppl 15): A-2063, 2009. |
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All registered patients were to have eligibility assessed and sign informed consent prior to registration and receipt of protocol therapy.
This study was activated on November 15, 1998 and closed to accrual on June 1, 2005. This was open to all SWOG institutions with IRB approval. Eastern Cooperative Oncology Group (ECOG) joined this trial on May 14, 2004.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydroxyurea | Only eligible patients were included in the analyses. Patients received 20 mg/kg/day taken orally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| St. Joseph's Hospital and Medical Center |
| Phoenix |
| Arizona |
| 85001-2071 |
| United States |
| CCOP - Western Regional, Arizona | Phoenix | Arizona | 85006-2726 | United States |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado | 80010 | United States |
| St. Anthony Central Hospital | Denver | Colorado | 80204-1335 | United States |
| Denver Health Medical Center | Denver | Colorado | 80204-4507 | United States |
| Veterans Affairs Medical Center - Denver | Denver | Colorado | 80220 | United States |
| Montrose Memorial Hospital Cancer Center | Montrose | Colorado | 81401 | United States |
| St. Anthony North Hospital | Westminster | Colorado | 80030 | United States |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| M.D. Anderson Cancer Center - Orlando | Orlando | Florida | 32806-2134 | United States |
| North Idaho Cancer Center | Coeur d'Alene | Idaho | 83814 | United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60504-4206 | United States |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| University of Illinois Medical Center | Chicago | Illinois | 60612 | United States |
| Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago | Illinois | 60612 | United States |
| Eureka Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| InterCommunity Cancer Center of Western Illinois | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| Joliet Oncology Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Kewanee Hospital | Kewanee | Illinois | 61443 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| Edward Hospital Cancer Center | Naperville | Illinois | 60540 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615-7828 | United States |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria | Illinois | 61615-7828 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | United States |
| Valley Cancer Center | Spring Valley | Illinois | 61362 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Carle Clinic Association | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360-4358 | United States |
| Siouxland Hematology-Oncology Associates | Sioux City | Iowa | 51101-1733 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51101 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, P.A. - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas - Ottawa | Ottawa | Kansas | 66067 | United States |
| Cancer Center of Kansas, P.A. - Parsons | Parsons | Kansas | 67357 | United States |
| Pratt Cancer Center of Kansas | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | United States |
| Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health | Wichita | Kansas | 67203 | United States |
| Cancer Center of Kansas, P.A. - Wichita | Wichita | Kansas | 67214-3728 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Baton Rouge General Regional Cancer Center | Baton Rouge | Louisiana | 70821 | United States |
| Cancer Center at Medical Center of Louisiana - New Orleans | New Orleans | Louisiana | 70140-1015 | United States |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Josephine Ford Cancer Center at Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Mercy and Unity Hospitals | Fridley | Minnesota | 55432-2799 | United States |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Clinic | Saint Louis Park | Minnesota | 55416 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | 64128 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Great Falls Clinic | Great Falls | Montana | 59403 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195-9001 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| Mount Carmel West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Community Oncology Group - Independence | Independence | Ohio | 44131 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750-1635 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055-2899 | United States |
| Mercy Medical Center Oncology Unit | Springfield | Ohio | 45501 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | 57104 | United States |
| Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota | 57105-1080 | United States |
| Medical X-Ray Center | Sioux Falls | South Dakota | 57105 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234-6200 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236-5300 | United States |
| Center for Cancer Prevention and Care at Scott and White Clinic | Temple | Texas | 76508 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Logan Regional Hospital | Logan | Utah | 84341 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112-5550 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| Grays Harbor Community Hospital | Aberdeen | Washington | 98520 | United States |
| Auburn Regional Center for Cancer Care at Auburn Regional Medical Center | Auburn | Washington | 98001-4908 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland | Washington | 98034-3013 | United States |
| St. Clare Hospital | Lakewood | Washington | 98499-0998 | United States |
| Capital Medical Center | Olympia | Washington | 98502 | United States |
| Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | 98506 | United States |
| Olympic Medical Center | Port Angeles | Washington | 98362 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98371 | United States |
| Valley Medical Center | Renton | Washington | 98055 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| St. Joseph Medical Center at Franciscan Health System | Tacoma | Washington | 98405-3004 | United States |
| Allenmore Hospital | Tacoma | Washington | 98411-0414 | United States |
| Camden-Clark Memorial Hospital | Parkersburg | West Virginia | 26102 | United States |
| Eligible |
|
| Eligible and Began Protocol Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydroxyurea | Only eligible patients were included in the analyses. Patients received 20 mg/kg/day taken orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity was captured at baseline and is reported per NIH/OMB categorization. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Race of participant was collected at baseline and is reported per the NIH/OMB categorization. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | 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 | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed). | All eligible patients who started treatment were included in assessing response estimates. | Posted | Number | Participants | Patients treated for 2 years or progression. If responding can continue at physician's discretion. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal | Eligible patients who had received any hydroxyurea were included in the adverse event summaries. Any CTC 2.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. | Posted | Number | Participants with a given type of AE | Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months |
|
|
Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months.
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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 | Hydroxyurea | Patients received Hydroxyurea (20 mg/kg/day orally) up to 2 years in absence of progressive disease. | 0 | 28 | 28 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation/bowel obstruction | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue/malaise/lethargy | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection w/o 3-4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia/granulocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/light headedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Seizures | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weakness (motor neuropathy) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
Early termination leading to fewer than expected subjects analyzed. With 28 eligible patients estimate of response probability can be estimated to within +/- 19%.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | (206)667-4623 |
| ID | Term |
|---|---|
| D008579 | Meningioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006918 | Hydroxyurea |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Unconfirmed Partial Response (UPR) |
|
| No Response |
|
|