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Business objectives have changed.
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The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Advanced therapy-naive | Experimental |
| |
| Cohort 2 - Advanced therapy-exposed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12 | Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score:
The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components:
The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition. | At week 12 |
| Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 2 at Week 26 | Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score:
The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components:
The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition. | At week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A Treatment Emergent Adverse Event (TEAE) is an AE that meets any of the following:
Participants meeting any of these conditions are counted as having at least one TEAE. |
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Inclusion Criteria:
A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration
Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:
i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).
Report of a previous colonoscopy that documents extent of disease
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0048 | Dothan | Alabama | 36305-1156 | United States | ||
| Local Institution - 0206 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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Total 139 participants were enrolled and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Ozanimod Advanced Therapy Naïve | Advanced therapy naïve participants received ozanimod 0.92 mg daily |
| FG001 | Cohort 2: Ozanimod Advanced Therapy Exposed | Advanced therapy exposed participants received ozanimod 0.92 mg daily |
| 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 | Aug 22, 2022 |
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| From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, is a congenital anomaly/birth defect, requires in-patient hospitalization or causes prolongation of existing hospitalization, or results in persistent/significant disability/incapacity. Treatment Emergent Serious Adverse Event (TE SAE) is a SAE that meets any of the following:
Participants meeting any of these conditions are counted as having at least one TESAE. | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| Number of Participants With Treatment Emergent Adverse Event of Interest | This endpoint reports the number of participants who experienced Adverse Events of Interest (AEIs) during the study. AEIs include bradycardia, heart conduction abnormalities (second-degree and higher atrioventricular block), macular edema, malignancy, serious or opportunistic infection, pulmonary effects, hepatic effects, posterior reversible encephalopathy syndrome, progressive multifocal leukoencephalopathy (PML), and events associated with orthostatic hypotension (e.g., dizziness, lightheadedness, syncope, seizure). The Sponsor may request additional information for nonserious AEIs. A Treatment Emergent AEI is an AEI that starts after the first dose (or within 84 days after stopping), worsens relative to baseline in this period (or within 84 days after stopping), or has missing dates making the timing unclear. Participants meeting any of these conditions are counted as having at least one AEI. | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation | This endpoint measures the number of participants who experienced Treatment Emergent Adverse Events (TEAEs) that resulted in discontinuation of study treatment. An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A TEAE is an AE that: starts after the first dose (or within 84 days after stopping) and was not present before; or was preexisting but worsens after the first dose (or within 84 days after stopping); or has missing dates that prevent determining whether it occurred outside the treatment emergent period. | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| Number of Participants With Clinically Significant Changes in Laboratory Assessments | Number of participants experiencing clinically significant abnormalities in laboratory testing including hematology, chemistry and urinalysis. | From first dose of study medication through end of study (Up to approximately 728 days) |
| Percent of Participants Achieving Clinical Remission by Partial Mayo Score at Week 52 and 104 | Clinical remission is defined as a Partial Mayo Score of ≤ 2.5. The Partial Mayo Score is a tool that helps doctors measure how active ulcerative colitis is without using endoscopy. It combines three components:
The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity. A score of 2.5 or below suggests the disease is in remission. | At week 52 and week 104 |
| Percent of Participants Achieving Corticosteroid-free Clinical Remission by Partial Mayo Score at Week 52 and 104 | Corticosteroid-free Clinical Remission (Partial Mayo Score) is defined as:
The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components:
The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity | At week 52 and week 104 |
| Percent of Participants Achieving Clinical Response by Partial Mayo Score at Week 52 and 104 | Clinical Response by Partial Mayo Score is defined as:
The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components:
The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity. | At week 52 and week 104 |
| Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 1 at Week 12 | Clinical remission by Modified Mayo Score is defined as meeting all of the following criteria:
The Modified Mayo Score is the sum of the following components (Range: 0-9):
The total score ranges from 0 to 9, with lower scores meaning less disease activity and better clinical condition, and higher scores meaning more severe disease activity. | At week 12 |
| Percent of Participants Achieving Endoscopic Response for Cohort 1 at Week 12 | Endoscopic Response is defined as: • A decrease from baseline of ≥ 1 point in the Mayo Endoscopic Score (ES). Mayo Endoscopic Score: range 0-3
| At week 12 |
| Percent of Participants Achieving Endoscopic Improvement for Cohort 1 at Week 12 | Endoscopic Improvement is defined as: • Mayo Endoscopic Score (ES) ≤ 1 Mayo Endoscopic Score (ES): range 0-3
| At week 12 |
| Percent of Participants Achieving Histological Improvement for Cohort 1 at Week 12 | Histological Improvement is defined as: • Achieving a Geboes score < 3.1 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.
| At week 12 |
| Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 12 for Cohort 1 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring: Each question ranges from 1 ("worst") to 7 ("best"). Total score: 32-224, with higher scores indicating better quality of life (QOL). An increase from baseline reflects improved health-related quality of life (HRQOL). The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall HRQOL. | At baseline and week 12 |
| Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 12] for Cohort 1 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A change from baseline in total score of ≥16 points reflect meaningful IBDQ response. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | At baseline and week 12 |
| Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 1 at Week 12 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A total score of ≥170 points reflects IBDQ remission, meaning the participant reports very few symptoms and good overall quality of life. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | At week 12 |
| Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 2 at Week 26 | Clinical remission by Modified Mayo Score is defined as meeting all of the following criteria:
The Modified Mayo Score is the sum of the following components (Range: 0-9):
The total score ranges from 0 to 9, with lower scores meaning less disease activity and better clinical condition, and higher scores meaning more severe disease activity. | At week 26 |
| Percent of Participants Achieving Endoscopic Response for Cohort 2 at Week 26 | Endoscopic Response is defined as: • A decrease from baseline of ≥ 1 point in the Mayo Endoscopic Sub score (ES). This represents the percentage of treated participants who achieved a decrease from baseline of at least 1 point in the Mayo ES, indicating improvement in mucosal appearance during endoscopy. Mayo Endoscopic Subscore (ES): range 0-3
| At week 26 |
| Percent of Participants Achieving Endoscopic Improvement for Cohort 2 at Week 26 | Endoscopic Improvement is defined as: • Mayo Endoscopic Subscore (ES) ≤ 1 This represents the percentage of treated participants with Mayo ES ≤ 1, indicating mild or no inflammation. Mayo Endoscopic Subscore (ES): range 0-3
| At week 26 |
| Percent of Participants Achieving Endoscopic Remission for Cohort 2 at Week 26 | Endoscopic Remission is defined as: • Mayo Endoscopic Sub score (ES) = 0 This represents the percentage of treated participants with Mayo ES = 0, indicating complete mucosal healing. Mayo Endoscopic Sub score (ES): range 0-3
| At week 26 |
| Percent of Participants Achieving Histological Improvement for Cohort 2 at Week 26 | Histological Improvement is defined as: • Achieving a Geboes score < 3.1 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.
| At week 26 |
| Percent of Participants Achieving Histological Remission for Cohort 2 at Week 26 | Histological Remission is defined as: • Achieving a Geboes score < 2 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.
| At week 26 |
| Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 26 for Cohort 2 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring: Each question ranges from 1 ("worst") to 7 ("best"). Total score: 32-224, with higher scores indicating better quality of life (QOL). An increase from baseline reflects improved health-related quality of life (HRQOL). The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall HRQOL. | At baseline and week 26 |
| Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 26] for Cohort 2 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A change from baseline in total score of ≥16 points reflect meaningful IBDQ response. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | At baseline and week 26 |
| Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 2 at Week 26 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A total score of ≥170 points reflect IBDQ remission, meaning the participant reports very few symptoms and good overall quality of life. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | At week 26 |
| Percent of Participants Achieving Corticosteroid-free Clinical Remission by Modified Mayo Score for Cohort 2 at Week 26 | Corticosteroid-free Clinical Remission (modified mayo score) is defined as:
The Modified Mayo Score is the sum of the following components (Range: 0-9):
The total score ranges from 0 to 9, with:
| At week 26 |
| Percent of Participants Achieving Histo-endoscopic Mucosal Improvement (HEMI) for Cohort 2 at Week 26 | Histo-endoscopic Mucosal Improvement (HEMI) is defined as:
Mayo Endoscopic Subscore (ES): range 0-3
Geboes Score:
Meeting both criteria (ES ≤ 1 and Geboes < 3.1) shows improvement in both endoscopic appearance and microscopic tissue health. | At week 26 |
| Chandler |
| Arizona |
| 85224-1636 |
| United States |
| Local Institution - 0216 | Gilbert | Arizona | 85297-0425 | United States |
| Local Institution - 0125 | Sun City | Arizona | 85351-2867 | United States |
| Local Institution - 0195 | Tucson | Arizona | 85724-0001 | United States |
| Local Institution - 0045 | North Little Rock | Arkansas | 72117-2927 | United States |
| Local Institution - 0165 | Apple Valley | California | 92307-1329 | United States |
| Local Institution - 0162 | Camarillo | California | 93012-5156 | United States |
| Local Institution - 0014 | Lancaster | California | 93534-5856 | United States |
| OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California | 93534-5856 | United States |
| Local Institution - 0209 | Los Angeles | California | 90045-3119 | United States |
| Local Institution - 0002 | San Diego | California | 92103-5639 | United States |
| Local Institution - 0208 | San Diego | California | 92123-4207 | United States |
| Local Institution - 0185 | San Jose | California | 95116 | United States |
| Local Institution - 0178 | Littleton | Colorado | 80120-5641 | United States |
| Gastro Florida | Clearwater | Florida | 33756-3839 | United States |
| Local Institution - 0018 | Clearwater | Florida | 33756-3839 | United States |
| Local Institution - 0050 | Homestead | Florida | 33033 | United States |
| Local Institution - 0026 | Lighthouse PT | Florida | 33064-7058 | United States |
| Local Institution - 0167 | Miami | Florida | 33136-1002 | United States |
| Local Institution - 0049 | Miami Lakes | Florida | 33016-5861 | United States |
| Wellness Clinical Research-Miami Florida | Miami Lakes | Florida | 33016-5861 | United States |
| Gastroenterology Group of Naples | Naples | Florida | 34102-5449 | United States |
| Local Institution - 0003 | Naples | Florida | 34102-5449 | United States |
| Local Institution - 0058 | Orange Park | Florida | 32073-4752 | United States |
| Local Institution - 0205 | Orlando | Florida | 32806-1110 | United States |
| Local Institution - 0037 | Palm Harbor | Florida | 34684 | United States |
| Local Institution - 0179 | Wellington | Florida | 33414-3187 | United States |
| Local Institution - 0027 | Roswell | Georgia | 30076-4969 | United States |
| Local Institution - 0198 | Arlington Heights | Illinois | 60005 | United States |
| Local Institution - 0051 | Chicago | Illinois | 60611 | United States |
| Local Institution - 0098 | Gurnee | Illinois | 60031 | United States |
| Local Institution - 0192 | Kansas City | Kansas | 66160-8500 | United States |
| Local Institution - 0181 | Topeka | Kansas | 66606-1539 | United States |
| Local Institution - 0183 | Louisville | Kentucky | 40202 | United States |
| Local Institution - 0200 | Baton Rouge | Louisiana | 70809-2440 | United States |
| Local Institution - 0171 | Chevy Chase | Maryland | 20815-7313 | United States |
| Local Institution - 0191 | Glen Burnie | Maryland | 21061-9121 | United States |
| Local Institution - 0199 | Boston | Massachusetts | 02111 | United States |
| Local Institution - 0196 | Worcester | Massachusetts | 01655 | United States |
| Local Institution - 0174 | Plymouth | Minnesota | 55446-3661 | United States |
| Local Institution - 0184 | Ocean Springs | Mississippi | 39564-5803 | United States |
| Local Institution - 0024 | Chesterfield | Missouri | 63005-1248 | United States |
| Local Institution - 0213 | Weldon Spring | Missouri | 63304-9103 | United States |
| Local Institution - 0180 | Englewood | New Jersey | 07631-4141 | United States |
| Local Institution - 0084 | Brooklyn | New York | 11203-2054 | United States |
| Local Institution - 0187 | New York | New York | 10016-6821 | United States |
| Local Institution - 0059 | New York | New York | 10016-9401 | United States |
| NYU Langone Health -Inflammatory Bowel Disease Center | New York | New York | 10016-9401 | United States |
| Local Institution - 0176 | New York | New York | 10021 | United States |
| Local Institution - 0170 | Utica | New York | 13502 | United States |
| Carolina Digestive Diseases | Greenville | North Carolina | 27834-3761 | United States |
| Local Institution - 0005 | Cincinnati | Ohio | 45229-3019 | United States |
| University of Cincinnati Physicians Company | Cincinnati | Ohio | 45229-3019 | United States |
| Local Institution - 0188 | Columbus | Ohio | 43235-5424 | United States |
| Local Institution - 0061 | Mentor | Ohio | 44060-6521 | United States |
| Local Institution - 0060 | Providence | Rhode Island | 02905-3105 | United States |
| Local Institution - 0177 | Cordova | Tennessee | 38018-6362 | United States |
| Local Institution - 0168 | Nashville | Tennessee | 37211-4981 | United States |
| Local Institution - 0038 | Bellaire | Texas | 77401 | United States |
| Novel Research LLC | Bellaire | Texas | 77401 | United States |
| Local Institution - 0138 | Dallas | Texas | 75246 | United States |
| Local Institution - 0036 | Houston | Texas | 77024-2469 | United States |
| Local Institution - 0163 | Houston | Texas | 77024-2469 | United States |
| Ace Clinical Research Group: Digestive Health Associates | Houston | Texas | 77024 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Local Institution - 0052 | Houston | Texas | 77030 | United States |
| Local Institution - 0129 | Katy | Texas | 77494 | United States |
| Local Institution - 0161 | Lubbock | Texas | 79410-2014 | United States |
| GI Alliance: Mansfield - TDDC | Mansfield | Texas | 76063-6083 | United States |
| Local Institution - 0039 | Mansfield | Texas | 76063-6083 | United States |
| Local Institution - 0201 | San Antonio | Texas | 78229-3270 | United States |
| Local Institution - 0043 | San Antonio | Texas | 78229-4463 | United States |
| San Antonio Gastroenterology | San Antonio | Texas | 78229-4463 | United States |
| Local Institution - 0166 | San Marcos | Texas | 78666-7502 | United States |
| Local Institution - 0046 | Tyler | Texas | 75701-4464 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701-4464 | United States |
| Local Institution - 0091 | Webster | Texas | 77598 | United States |
| Local Institution - 0193 | Ogden | Utah | 84403-3294 | United States |
| Local Institution - 0169 | Salt Lake City | Utah | 84132-0001 | United States |
| Local Institution - 0197 | Lynchburg | Virginia | 24502 | United States |
| Local Institution - 0130 | Seattle | Washington | 98104-1356 | United States |
| Local Institution - 0189 | Tacoma | Washington | 98405-2318 | United States |
| Local Institution - 0017 | Madison | Wisconsin | 53705-1311 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Ozanimod Advanced Therapy Naïve | Advanced therapy naïve participants received ozanimod 0.92 mg daily |
| BG001 | Cohort 2: Ozanimod Advanced Therapy Exposed | Advanced therapy exposed participants received ozanimod 0.92 mg daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12 | Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score:
The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components:
The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition. | Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 12 |
|
|
| |||||||||||||||||||||||||||
| Primary | Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 2 at Week 26 | Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score:
The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components:
The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition. | Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A Treatment Emergent Adverse Event (TEAE) is an AE that meets any of the following:
Participants meeting any of these conditions are counted as having at least one TEAE. | Treated participants | Posted | Count of Participants | Participants | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, is a congenital anomaly/birth defect, requires in-patient hospitalization or causes prolongation of existing hospitalization, or results in persistent/significant disability/incapacity. Treatment Emergent Serious Adverse Event (TE SAE) is a SAE that meets any of the following:
Participants meeting any of these conditions are counted as having at least one TESAE. | Treated participants | Posted | Count of Participants | Participants | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Event of Interest | This endpoint reports the number of participants who experienced Adverse Events of Interest (AEIs) during the study. AEIs include bradycardia, heart conduction abnormalities (second-degree and higher atrioventricular block), macular edema, malignancy, serious or opportunistic infection, pulmonary effects, hepatic effects, posterior reversible encephalopathy syndrome, progressive multifocal leukoencephalopathy (PML), and events associated with orthostatic hypotension (e.g., dizziness, lightheadedness, syncope, seizure). The Sponsor may request additional information for nonserious AEIs. A Treatment Emergent AEI is an AEI that starts after the first dose (or within 84 days after stopping), worsens relative to baseline in this period (or within 84 days after stopping), or has missing dates making the timing unclear. Participants meeting any of these conditions are counted as having at least one AEI. | Treated participants | Posted | Count of Participants | Participants | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation | This endpoint measures the number of participants who experienced Treatment Emergent Adverse Events (TEAEs) that resulted in discontinuation of study treatment. An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A TEAE is an AE that: starts after the first dose (or within 84 days after stopping) and was not present before; or was preexisting but worsens after the first dose (or within 84 days after stopping); or has missing dates that prevent determining whether it occurred outside the treatment emergent period. | Treated participants | Posted | Count of Participants | Participants | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Laboratory Assessments | Number of participants experiencing clinically significant abnormalities in laboratory testing including hematology, chemistry and urinalysis. | Treated participants | Posted | Count of Participants | Participants | From first dose of study medication through end of study (Up to approximately 728 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving Clinical Remission by Partial Mayo Score at Week 52 and 104 | Clinical remission is defined as a Partial Mayo Score of ≤ 2.5. The Partial Mayo Score is a tool that helps doctors measure how active ulcerative colitis is without using endoscopy. It combines three components:
The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity. A score of 2.5 or below suggests the disease is in remission. | Treated participants with observed cases | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 52 and week 104 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving Corticosteroid-free Clinical Remission by Partial Mayo Score at Week 52 and 104 | Corticosteroid-free Clinical Remission (Partial Mayo Score) is defined as:
The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components:
The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity | Treated participants with observed cases | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 52 and week 104 |
| |||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving Clinical Response by Partial Mayo Score at Week 52 and 104 | Clinical Response by Partial Mayo Score is defined as:
The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components:
The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity. | Treated participants with observed cases | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 52 and week 104 |
| |||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 1 at Week 12 | Clinical remission by Modified Mayo Score is defined as meeting all of the following criteria:
The Modified Mayo Score is the sum of the following components (Range: 0-9):
The total score ranges from 0 to 9, with lower scores meaning less disease activity and better clinical condition, and higher scores meaning more severe disease activity. | Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 12 |
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| Secondary | Percent of Participants Achieving Endoscopic Response for Cohort 1 at Week 12 | Endoscopic Response is defined as: • A decrease from baseline of ≥ 1 point in the Mayo Endoscopic Score (ES). Mayo Endoscopic Score: range 0-3
| Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 12 |
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| Secondary | Percent of Participants Achieving Endoscopic Improvement for Cohort 1 at Week 12 | Endoscopic Improvement is defined as: • Mayo Endoscopic Score (ES) ≤ 1 Mayo Endoscopic Score (ES): range 0-3
| Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 12 |
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| Secondary | Percent of Participants Achieving Histological Improvement for Cohort 1 at Week 12 | Histological Improvement is defined as: • Achieving a Geboes score < 3.1 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.
| Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 12 |
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| Secondary | Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 12 for Cohort 1 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring: Each question ranges from 1 ("worst") to 7 ("best"). Total score: 32-224, with higher scores indicating better quality of life (QOL). An increase from baseline reflects improved health-related quality of life (HRQOL). The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall HRQOL. | Treated participants. Pre-specified to be reported for Cohort 1 only. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and week 12 |
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| Secondary | Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 12] for Cohort 1 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A change from baseline in total score of ≥16 points reflect meaningful IBDQ response. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At baseline and week 12 |
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| Secondary | Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 1 at Week 12 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A total score of ≥170 points reflects IBDQ remission, meaning the participant reports very few symptoms and good overall quality of life. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 12 |
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| Secondary | Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 2 at Week 26 | Clinical remission by Modified Mayo Score is defined as meeting all of the following criteria:
The Modified Mayo Score is the sum of the following components (Range: 0-9):
The total score ranges from 0 to 9, with lower scores meaning less disease activity and better clinical condition, and higher scores meaning more severe disease activity. | Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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| Secondary | Percent of Participants Achieving Endoscopic Response for Cohort 2 at Week 26 | Endoscopic Response is defined as: • A decrease from baseline of ≥ 1 point in the Mayo Endoscopic Sub score (ES). This represents the percentage of treated participants who achieved a decrease from baseline of at least 1 point in the Mayo ES, indicating improvement in mucosal appearance during endoscopy. Mayo Endoscopic Subscore (ES): range 0-3
| Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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| Secondary | Percent of Participants Achieving Endoscopic Improvement for Cohort 2 at Week 26 | Endoscopic Improvement is defined as: • Mayo Endoscopic Subscore (ES) ≤ 1 This represents the percentage of treated participants with Mayo ES ≤ 1, indicating mild or no inflammation. Mayo Endoscopic Subscore (ES): range 0-3
| Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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| Secondary | Percent of Participants Achieving Endoscopic Remission for Cohort 2 at Week 26 | Endoscopic Remission is defined as: • Mayo Endoscopic Sub score (ES) = 0 This represents the percentage of treated participants with Mayo ES = 0, indicating complete mucosal healing. Mayo Endoscopic Sub score (ES): range 0-3
| Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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| Secondary | Percent of Participants Achieving Histological Improvement for Cohort 2 at Week 26 | Histological Improvement is defined as: • Achieving a Geboes score < 3.1 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.
| Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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| Secondary | Percent of Participants Achieving Histological Remission for Cohort 2 at Week 26 | Histological Remission is defined as: • Achieving a Geboes score < 2 The Geboes score is a grading system used to assess inflammation in tissue samples under a microscope.
| Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
|
| ||||||||||||||||||||||||||||
| Secondary | Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 26 for Cohort 2 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring: Each question ranges from 1 ("worst") to 7 ("best"). Total score: 32-224, with higher scores indicating better quality of life (QOL). An increase from baseline reflects improved health-related quality of life (HRQOL). The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall HRQOL. | Treated participants. Pre-specified to be reported for Cohort 2 only. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and week 26 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 26] for Cohort 2 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A change from baseline in total score of ≥16 points reflect meaningful IBDQ response. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At baseline and week 26 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 2 at Week 26 | IBDQ is a tool to assess patient experience in inflammatory bowel diseases (Ulcerative Colitis [UC] and Crohn's Disease [CD]). It includes 32 questions across 4 dimensions:
Scoring:
A total score of ≥170 points reflect IBDQ remission, meaning the participant reports very few symptoms and good overall quality of life. The IBDQ is used in registrational studies to evaluate bowel symptoms, functional abdominal symptoms, and overall health-related quality of life (HRQOL). | Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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| Secondary | Percent of Participants Achieving Corticosteroid-free Clinical Remission by Modified Mayo Score for Cohort 2 at Week 26 | Corticosteroid-free Clinical Remission (modified mayo score) is defined as:
The Modified Mayo Score is the sum of the following components (Range: 0-9):
The total score ranges from 0 to 9, with:
| Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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| Secondary | Percent of Participants Achieving Histo-endoscopic Mucosal Improvement (HEMI) for Cohort 2 at Week 26 | Histo-endoscopic Mucosal Improvement (HEMI) is defined as:
Mayo Endoscopic Subscore (ES): range 0-3
Geboes Score:
Meeting both criteria (ES ≤ 1 and Geboes < 3.1) shows improvement in both endoscopic appearance and microscopic tissue health. | Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Posted | Number | 95% Confidence Interval | Percent of Participants | At week 26 |
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Participants were assessed for all-cause mortality from first dose to study completion (up to approximately 847 days). SAEs and Other AEs were assessed from first dose of study medication through post-medication follow-up visit (Up to approximately 812 days).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Ozanimod Advanced Therapy Naive | Advanced therapy naïve participants received ozanimod 0.92 mg daily | 1 | 99 | 7 | 99 | 28 | 99 |
| EG001 | Cohort 2: Ozanimod Advanced Therapy Exposed | Advanced therapy exposed participants received ozanimod 0.92 mg daily | 0 | 40 | 4 | 40 | 9 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Jan 7, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607776 | ozanimod |
Not provided
Not provided
Not provided
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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