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The primary objective of the study is to assess the safety and tolerability of multiple infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Andecaliximab | Experimental | Participants will receive andecaliximab every 2 weeks for a total of 3 infusions. |
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| Placebo to match andecaliximab | Placebo Comparator | Participants will receive placebo to match andecaliximab every 2 weeks for a total of 3 infusions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Andecaliximab | Drug | 400 mg andecaliximab administered intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to Day 29 plus 30 days | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant. | First dose date up to Day 29 plus 30 days |
| Percentage of Participants Who Developed Anti-andecaliximab Antibodies | The presence of anti-andecaliximab antibodies in serum samples was determined using an electrochemiluminescent (ECL) assay that detects antibodies that bind to andecaliximab. | Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter of Andecaliximab: AUClast for Days 1, 15 and 29 | AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Pharma CR, LLC | Miami | Florida | 33136 | United States | ||
| Elite Research Institute |
33 participants were screened.
Participants were enrolled at study sites in United States. The first participant was screened on 11 March 2014. The last study visit occurred on 27 October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Andecaliximab | Participants received intravenous (IV) infusion of andecaliximab (400 mg) once every 2 weeks for a total of 3 infusions. |
| FG001 | Placebo | Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo to match Andecaliximab | Drug | Placebo to match andecaliximab administered intravenously |
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| Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
| PK Parameter of Andecaliximab: AUCinf for Day 1 | AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
| PK Parameter of Andecaliximab: %AUCexp for Day 1 | %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
| PK Parameter of Andecaliximab: Cmax for Days 1, 15 and 29 | Cmax is defined as the maximum observed plasma concentration of drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
| PK Parameter of Andecaliximab: Tmax for Days 1, 15 and 29 | Tmax is defined as the time (observed time point) of Cmax. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
| PK Parameter of Andecaliximab: Clast for Days 1, 15 and 29 | Clast is defined as the last observable concentration of drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
| PK Parameter of Andecaliximab: Tlast for Days 1, 15 and 29 | Tlast is defined as the time (observed time point) of Clast. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
| PK Parameter of Andecaliximab: λz for Day 1 | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
| PK Parameter of Andecaliximab: CL for Day 1 | Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
| PK Parameter of Andecaliximab: Vz for Day 1 | Vz is defined as the volume of distribution of the drug after intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
| PK Parameter of Andecaliximab: Vss for Day 1 | Vss is defined as the volume of distribution of the drug at steady state after intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
| PK Parameter of Andecaliximab: t1/2 for Day 1 | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
| Miami |
| Florida |
| 33169 |
| United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| University at Buffalo CTRC | Buffalo | New York | 14203 | United States |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Andecaliximab | Participants received IV infusion of andecaliximab 400 mg once every 2 weeks for a total of 3 infusions. |
| BG001 | Placebo | Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo). | Posted | Number | percentage of participants | First dose date up to Day 29 plus 30 days |
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| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to Day 29 plus 30 days |
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| Primary | Percentage of Participants Who Developed Anti-andecaliximab Antibodies | The presence of anti-andecaliximab antibodies in serum samples was determined using an electrochemiluminescent (ECL) assay that detects antibodies that bind to andecaliximab. | The immunogenicity analysis set included participants who received any amount of andecaliximab. | Posted | Number | percentage of participants | Day 43 |
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| Secondary | Pharmacokinetic (PK) Parameter of Andecaliximab: AUClast for Days 1, 15 and 29 | AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | The PK analysis set included all participants in the safety analysis set who have an evaluable PK profile. | Posted | Mean | Standard Deviation | day*ug/mL | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: AUCinf for Day 1 | AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day*ug/mL | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: %AUCexp for Day 1 | %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of AUC | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: Cmax for Days 1, 15 and 29 | Cmax is defined as the maximum observed plasma concentration of drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ug/mL | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: Tmax for Days 1, 15 and 29 | Tmax is defined as the time (observed time point) of Cmax. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: Clast for Days 1, 15 and 29 | Clast is defined as the last observable concentration of drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ug/mL | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: Tlast for Days 1, 15 and 29 | Tlast is defined as the time (observed time point) of Clast. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. Data for Day 15 was generated based on the data collected from Day 15 through Day 29. Data for Day 29 was generated based on the data collected from Day 29 through Day 43. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day3, Day 8, Day 15 (pre-infusion; and 30 minutes post end of infusion), Day 29 (pre-infusion; and 30 minutes post end of infusion), Day 36 and Day 43; Infusion duration = 30 to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: λz for Day 1 | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | 1/day | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: CL for Day 1 | Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mL/day | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: Vz for Day 1 | Vz is defined as the volume of distribution of the drug after intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mL | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: Vss for Day 1 | Vss is defined as the volume of distribution of the drug at steady state after intravenous administration. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mL | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
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| Secondary | PK Parameter of Andecaliximab: t1/2 for Day 1 | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Data for Day 1 was generated based on the data collected from Day 1 through Day 15. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day | Day 1 (pre-infusion; 30 minutes and 4 hours post end of infusion), Day 3, Day 8, and Day 15 (pre-infusion); Infusion duration = 30 minutes to 35 minutes |
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First dose date up to Day 29 plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 infusion of study drug (andecaliximab or placebo).
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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 | Andecaliximab | Participants received IV infusion of andecaliximab 200 mg once every 2 weeks for a total of 3 infusions. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG001 | Placebo | Participants received IV infusion of placebo once every 2 weeks for a total of 3 infusions. | 0 | 3 | 0 | 3 | 1 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Periorbital contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Platelet count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000621903 | andecaliximab |
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| Male |
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| White |
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| Not Hispanic or Latino |
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