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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00130055 | Other Identifier | University of Michigan |
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The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of palbociclib (Ibrance) plus carboplatin in patients with metastatic head and neck squamous cell cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palbociclib and Carboplatin | Experimental | Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days Carboplatin (IV), dose= AUC 5, day= 1, cycle length: 21 days Maintenance Palbociclib after 6 cycles Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days Maintenance Palbociclib: Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Disease Control Rate (DCR) | The primary clinical objective of this trial is to estimate disease control rate (DCR) at 12 weeks in patients with metastatic head and neck squamous cell cancer treated with carboplatin and palbociclib. DCR will be defined as either CR (Complete Response: Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.), PR (Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.) or SD (Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.) at 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival Time | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. Estimated using a Kaplan-Meier analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Swiecicki, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
| University of Michigan Comprehensive Cancer Center |
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One enrolled patient withdrew prior to starting study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Palbociclib and Carboplatin | Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Oct 4, 2018 |
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| Carboplatin | Drug | Carboplatin (IV), dose= AUC 5, day= 1, cycle length: 21 days |
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| Up to 2 Years |
| Median Overall Survival Time | Overall survival is defined as the time from study enrollment to death from any cause. Estimated using a Kaplan-Meier analysis. | Up to 2 Years |
| Number of Treatment-related Toxicities | Number of adverse events believed to be related (i.e., possibly, probably, or definitely) to palbociclib in combination with carboplatin, reported by grade according to the Common Terminology for Adverse Events version 4.0 (CTCAE v4). | Up to 2 years |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Vanderbilt University | Nashville | Tennessee | 37203 | United States |
| Received Palbociclib and Carboplatin | One participant received carboplatin but never received palbociclib |
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| COMPLETED | Evaluable for response |
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| NOT COMPLETED |
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21 patients enrolled; 18 were evaluable for response. One patient was not started on therapy after enrollment due to abrupt decline in performance status, another received carboplatin but never received palbociclib. A third patient was removed from study prior to imaging per physician discretion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Palbociclib and Carboplatin | Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ECOG Performance Status | 18 patients evaluable for response | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Disease Control Rate (DCR) | The primary clinical objective of this trial is to estimate disease control rate (DCR) at 12 weeks in patients with metastatic head and neck squamous cell cancer treated with carboplatin and palbociclib. DCR will be defined as either CR (Complete Response: Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.), PR (Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.) or SD (Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.) at 12 weeks. | Patients were considered evaluable for response if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
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| Secondary | Median Progression Free Survival Time | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. Estimated using a Kaplan-Meier analysis. | Patients were evaluable for survival if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib. | Posted | Median | Full Range | months | Up to 2 Years |
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| Secondary | Median Overall Survival Time | Overall survival is defined as the time from study enrollment to death from any cause. Estimated using a Kaplan-Meier analysis. | Patients were evaluable for survival if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib. | Posted | Median | Full Range | months | Up to 2 Years |
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| Secondary | Number of Treatment-related Toxicities | Number of adverse events believed to be related (i.e., possibly, probably, or definitely) to palbociclib in combination with carboplatin, reported by grade according to the Common Terminology for Adverse Events version 4.0 (CTCAE v4). | Patients were evaluable for treatment-related toxicities if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib. | Posted | Count of Participants | Participants | Up to 2 years |
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Adverse events were collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. All-cause mortality data was collected during entire study; 29 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 | Palbociclib and Carboplatin | Treatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-14 + Carboplatin AUC 5 IV, day 1; cycle length 21 days. Maintenance Palbociclib after 6 cycles: Palbociclib (Ibrance) 125 mg PO daily, days 1-21; cycle length 28 days. | 16 | 19 | 14 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Ataxia | Nervous system disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Infections and infestations - other | Infections and infestations | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Nervous system disorders - other | Nervous system disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Weight loss | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Eye disorders - Other, specify | Eye disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Flu like symptoms | General disorders | Systematic Assessment |
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| Gastrointestinal disorders - Other | Gastrointestinal disorders | Systematic Assessment |
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| General disorders and administration site conditions - Other | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nervous system disorders - Other, specify | Nervous system disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Weight loss | Investigations | Systematic Assessment |
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| White blood cell decreased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Swiecicki, M.D. | University of Michigan Rogel Cancer Center | 734-647-1017 | pswiecic@med.umich.edu |
| Jan 16, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 1 (Minor impairment) |
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