Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2018-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
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},
{
"op": "replace",
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},
{
"op": "replace",
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},
{
"op": "replace",
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{
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},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
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},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
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},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
"value": "Vitamin D"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
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{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
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{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
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},
{
"op": "replace",
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{
"op": "add",
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},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes"
},
{
"op": "remove",
"path": "/annotationSection"
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{
"op": "replace",
"path": "/hasResults",
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},
{
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"phone": "802-656-5452",
"title": "Marie E. Wood, M.D",
"organization": "University of Vermont"
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"term": "Diarrhea",
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"groupId": "EG000",
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}
],
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{
"term": "Gastroesophageal reflux disease",
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"term": "Nausea",
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{
"term": "Vomiting",
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},
{
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{
"groupId": "EG000",
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{
"groupId": "EG001",
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}
],
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},
{
"term": "Appendicitis perforated",
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{
"groupId": "EG000",
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"numAffected": 0
},
{
"groupId": "EG001",
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}
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{
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{
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}
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},
{
"term": "GGT increased",
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"numAffected": 1
},
{
"groupId": "EG001",
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}
],
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},
{
"term": "Hypercalcemia",
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{
"groupId": "EG000",
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{
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}
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{
"term": "Hyperglycemia",
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{
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{
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}
],
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},
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"term": "Pain in extremity",
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}
],
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{
"term": "Intracranial hemorrhage",
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{
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},
{
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}
],
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{
"term": "Dyspnea",
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{
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],
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{
"term": "Rash acneiform",
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{
"groupId": "EG000",
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{
"groupId": "EG001",
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}
],
"organSystem": "Skin and subcutaneous tissue disorders",
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},
{
"term": "Hematoma",
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"groupId": "EG000",
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},
{
"groupId": "EG001",
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],
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},
{
"term": "Hot flashes",
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{
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"title": "Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms",
"denoms": [
{
"units": "Participants",
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"groupId": "OG000"
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{
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}
]
}
],
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{
"id": "OG001",
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}
],
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{
"categories": [
{
"measurements": [
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"value": "-3.4",
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{
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}
]
}
]
}
],
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"description": "To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.\nThe percent change in breast density will be reported here.",
"unitOfMeasure": "percent change",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
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}
]
},
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"type": "STARTED",
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"groupId": "FG001",
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{
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],
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"groupId": "BG000",
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}
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}
],
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{
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{
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{
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},
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{
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}
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}
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},
{
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{
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{
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"groupId": "BG002"
}
]
},
{
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{
"value": "124",
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{
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}
]
},
{
"title": "Unknown or Not Reported",
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{
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{
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}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race (NIH/OMB)",
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{
"categories": [
{
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{
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{
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"groupId": "BG002"
}
]
},
{
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{
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{
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]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
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{
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{
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]
},
{
"title": "Black or African American",
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{
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},
{
"value": "35",
"groupId": "BG002"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "124",
"groupId": "BG000"
},
{
"value": "114",
"groupId": "BG001"
},
{
"value": "238",
"groupId": "BG002"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "4",
"groupId": "BG001"
},
{
"value": "5",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "5",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "150",
"groupId": "BG000"
},
{
"value": "150",
"groupId": "BG001"
},
{
"value": "300",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
}
],
"populationDescription": "All patients were used for baseline analysis"
}
}
}
]