NCT00691678
Version 6 to 7 · Dawn L. Hershman
Patch inspector
Manual review pending.
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Change in WOMAC Score
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria, which provides a combined assessment of changes in pain, function, and the patient's global assessment of disease status.
This is to demonstrate improvement in knee and/or joint pain and/or stiffness. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 24 weeks
Baseline and 24 weeks
/protocolSection/armsInterventionsModule/interventions/0/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. 400mg chondroitin TID for twenty-four weeks
400mg chondroitin three times a day (TID) for twenty-four weeks
/protocolSection/eligibilityModule/eligibilityCriteria eligibility_criteria_change Eligibility criteria changes can alter the studied population. <p>Inclusion Criteria:</p><ul><li>Age >21 years.</li><li>Postmenopausal status defined as cessation of menses for >1 year or FSH >20 mIU/mL or bilateral oophorectomy.</li><li>History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.</li><li>Currently taking a third-generation aromatase inhibitor for at least 3 months.</li><li>Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry.</li><li>Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.</li><li>Patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study.</li><li>If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose. Patients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.</li><li>ECOG performance status 0-2.</li><li>Hemoglobin A1c <8 within the last year.</li><li>Signed informed consent.</li></ul><p>Exclusion Criteria:</p><ul><li>Use of glucosamine or chondroitin within the past three (3) months.</li><li>Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy.</li><li>History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).</li><li>History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.</li><li>Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.</li><li>History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.</li><li>Allergy to, or history of significant clinical or laboratory adverse experience associated with acetaminophen, glucosamine or chondroitin sulfate.</li><li>Allergy to shellfish.</li><li>Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.</li><li>Inability to understand the study procedures and/or give written informed consent.</li><li>Alcohol use in excess of 3 mixed drinks/day.</li><li>Corticosteroid treatment was used or administered.</li><li>Aspirin (up to 325 mg/day) for cardiovascular reasons may be continued.</li><li>Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.</li><li>Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of baseline visit or during the study.</li><li>Implementation of any other medical therapy for arthritis within one month prior to entry.</li><li>Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month. In addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.</li><li>Participation in another clinical study with an investigational agent within the last 4 weeks.</li><li>Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of Baseline Visit.</li><li>Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry.</li><li><p>Concurrent use of the following medications and dietary supplements.</p><ul><li>Chronic therapy with tetracycline or tetracycline derivatives.</li><li>Other new complementary or alternative regimens for the treatment of osteoarthritis, including, but not limited to, acupuncture, topical creams, oral agents, and magnets.</li></ul></li></ul>
<p>Inclusion Criteria:</p><ul><li>Age >21 years.</li><li>Postmenopausal status defined as cessation of menses for >1 year or follicle-stimulating hormone (FSH) >20 milli-international units per milliliter or bilateral oophorectomy.</li><li>History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.</li><li>Currently taking a third-generation aromatase inhibitor for at least 3 months.</li><li>Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry.</li><li>Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.</li><li>Patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study.</li><li>If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose. Patients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status 0-2.</li><li>Hemoglobin A1c <8 within the last year.</li><li>Signed informed consent.</li></ul><p>Exclusion Criteria:</p><ul><li>Use of glucosamine or chondroitin within the past three (3) months.</li><li>Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy.</li><li>History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).</li><li>History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.</li><li>Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.</li><li>History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.</li><li>Allergy to, or history of significant clinical or laboratory adverse experience associated with acetaminophen, glucosamine or chondroitin sulfate.</li><li>Allergy to shellfish.</li><li>Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.</li><li>Inability to understand the study procedures and/or give written informed consent.</li><li>Alcohol use in excess of 3 mixed drinks/day.</li><li>Corticosteroid treatment was used or administered.</li><li>Aspirin (up to 325 mg/day) for cardiovascular reasons may be continued.</li><li>Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.</li><li>Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of baseline visit or during the study.</li><li>Implementation of any other medical therapy for arthritis within one month prior to entry.</li><li>Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month. In addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.</li><li>Participation in another clinical study with an investigational agent within the last 4 weeks.</li><li>Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of Baseline Visit.</li><li>Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry.</li><li><p>Concurrent use of the following medications and dietary supplements.</p><ul><li>Chronic therapy with tetracycline or tetracycline derivatives.</li><li>Other new complementary or alternative regimens for the treatment of osteoarthritis, including, but not limited to, acupuncture, topical creams, oral agents, and magnets.</li></ul></li></ul>
/protocolSection/statusModule/statusVerifiedDate 2017-06
2022-10
/protocolSection/statusModule/lastUpdateSubmitDate 2017-06-15
2022-10-14
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2017-06-19
2022-11-08
/protocolSection/statusModule/resultsFirstSubmitDate 2021-07-13
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"description": "This is to demonstrate improvement in knee and/or joint pain and/or stiffness.\nThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.\nIt is a self-administered questionnaire consisting of 24 items divided into 3 subscales.\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.\nThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\nThe sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96.\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.",
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"value": "<p>Inclusion Criteria:</p><ul><li>Age >21 years.</li><li>Postmenopausal status defined as cessation of menses for >1 year or follicle-stimulating hormone (FSH) >20 milli-international units per milliliter or bilateral oophorectomy.</li><li>History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.</li><li>Currently taking a third-generation aromatase inhibitor for at least 3 months.</li><li>Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry.</li><li>Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.</li><li>Patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study.</li><li>If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose.\nPatients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status 0-2.</li><li>Hemoglobin A1c <8 within the last year.</li><li>Signed informed consent.</li></ul><p>Exclusion Criteria:</p><ul><li>Use of glucosamine or chondroitin within the past three (3) months.</li><li>Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy.</li><li>History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).</li><li>History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.</li><li>Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.</li><li>History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.</li><li>Allergy to, or history of significant clinical or laboratory adverse experience associated with acetaminophen, glucosamine or chondroitin sulfate.</li><li>Allergy to shellfish.</li><li>Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.</li><li>Inability to understand the study procedures and/or give written informed consent.</li><li>Alcohol use in excess of 3 mixed drinks/day.</li><li>Corticosteroid treatment was used or administered.</li><li>Aspirin (up to 325 mg/day) for cardiovascular reasons may be continued.</li><li>Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.</li><li>Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of baseline visit or during the study.</li><li>Implementation of any other medical therapy for arthritis within one month prior to entry.</li><li>Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month.\nIn addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.</li><li>Participation in another clinical study with an investigational agent within the last 4 weeks.</li><li>Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of Baseline Visit.</li><li>Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry.</li><li><p>Concurrent use of the following medications and dietary supplements.</p><ul><li>Chronic therapy with tetracycline or tetracycline derivatives.</li><li>Other new complementary or alternative regimens for the treatment of osteoarthritis, including, but not limited to, acupuncture, topical creams, oral agents, and magnets.</li></ul></li></ul>"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "dlh23@cumc.columbia.edu",
"phone": "212-305-1945",
"title": "Dawn L. Hershman, MD",
"organization": "Columbia University"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
"timeFrame": "Up to 24 weeks",
"eventGroups": [
{
"id": "EG000",
"title": "Chondroitin and Glucosamine",
"description": "<p>Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.</p><p>Chondroitin: 400mg chondroitin TID for twenty-four weeks</p><p>Glucosamine: 500mg glucosamine TID for twenty-four weeks</p>",
"otherNumAtRisk": 53,
"deathsNumAtRisk": 53,
"otherNumAffected": 51,
"seriousNumAtRisk": 53,
"deathsNumAffected": 0,
"seriousNumAffected": 0
}
],
"otherEvents": [
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 9,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Dyspepsia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 9,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Flatulence",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Heartburn",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Gastrointestinal disorder",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Abdominal distension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Gastritis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Hiccough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Stomach Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Weight gain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 14,
"numAffected": 14
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Allergic reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Immune system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
},
{
"term": "Bleeding at the biopsy site",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 53,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT"
}
],
"frequencyThreshold": "0"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Change in WOMAC Score",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "39",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Chondroitin and Glucosamine",
"description": "<p>Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.</p><p>Chondroitin: 400mg chondroitin TID for twenty-four weeks</p><p>Glucosamine: 500mg glucosamine TID for twenty-four weeks</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "24.9",
"spread": "21.4",
"groupId": "OG000"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.004",
"groupIds": [
"OG000"
],
"paramType": "Mean Difference (Final Values)",
"ciNumSides": "TWO_SIDED",
"paramValue": "-13.3",
"groupDescription": "This statistical analysis measures whether there is a statistically significant change, at the 5% significance level, between the mean WOMAC score among study participants at baseline and at week 24.",
"statisticalMethod": "t-test, 2 sided",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEAN",
"timeFrame": "Baseline and 24 weeks",
"description": "This is to demonstrate improvement in knee and/or joint pain and/or stiffness.\nThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.\nIt is a self-administered questionnaire consisting of 24 items divided into 3 subscales.\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.\nThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\nThe sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96.\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.",
"unitOfMeasure": "Score on a scale",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"populationDescription": "At completion of the study, there were 39 evaluable subjects (this excludes participants who were not available for follow-up) out of the 53 enrolled."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Chondroitin and Glucosamine",
"description": "<p>Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.</p><p>Chondroitin: 400mg chondroitin three times a day (TID) for twenty-four weeks</p><p>Glucosamine: 500mg glucosamine TID for twenty-four weeks</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "53"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "37"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "16"
}
]
}
],
"dropWithdraws": [
{
"type": "Adverse Event",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "5"
}
]
},
{
"type": "life events, pain",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "11"
}
]
}
]
}
],
"recruitmentDetails": "53 women were enrolled in this study at baseline, 16 dropped out before the week 24 assessment. in total, there were 39 evaluable participants.",
"preAssignmentDetails": "Of the 16 participants that dropped out of the study, 5 did so because of the number of pills, 8 due to adverse events and uncontrolled pain, and 3 dropped out due to other life events.\n40 participants completed the 12 week assessment; 27 participants completed the 24 week assessment."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "53",
"groupId": "BG000"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Chondroitin and Glucosamine",
"description": "<p>Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.</p><p>Chondroitin: 400mg chondroitin TID for twenty-four weeks</p><p>Glucosamine: 500mg glucosamine TID for twenty-four weeks</p>"
}
],
"measures": [
{
"title": "Age, Customized",
"classes": [
{
"title": "18 - 58 years",
"categories": [
{
"measurements": [
{
"value": "23",
"groupId": "BG000"
}
]
}
]
},
{
"title": "59 - 78 years",
"categories": [
{
"measurements": [
{
"value": "24",
"groupId": "BG000"
}
]
}
]
},
{
"title": "> or = 79",
"categories": [
{
"measurements": [
{
"value": "6",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "53",
"groupId": "BG000"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Ethnicity (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "20",
"groupId": "BG000"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "33",
"groupId": "BG000"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "American Indian or Alaska Native",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "1",
"groupId": "BG000"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Black or African American",
"measurements": [
{
"value": "14",
"groupId": "BG000"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "38",
"groupId": "BG000"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "53",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
}
}
]