Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2018-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2016-07-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2016-07-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2018-10-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2018-11-07"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2018-08-17"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2018-10-08"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2018-11-07",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.")\nover 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Up to 12 weeks"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale.\nThe EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL).\nThe aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.\nFor example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period.\nThen these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/measure",
"value": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
"value": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); "Over the past week, did you experience fatigue?") over 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
"value": "Baseline to up to 12 weeks"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "cloprinzi@mayo.edu",
"phone": "507/284-6026",
"title": "Charles L. Loprinzi, M.D.",
"organization": "Mayo Clinic"
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": false
}
},
"adverseEventsModule": {
"timeFrame": "Up to 12 weeks",
"description": "The descriptions & grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.\nEach CTCAE term in the current version is a unique representation of a specific event used for medical documentation & scientific analysis & is a single MedDRA Lowest Level Term (LLT).",
"eventGroups": [
{
"id": "EG000",
"title": "Arm I (Minocycline Hydrochloride)",
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"otherNumAtRisk": 22,
"deathsNumAtRisk": 22,
"otherNumAffected": 8,
"seriousNumAtRisk": 22,
"deathsNumAffected": 0,
"seriousNumAffected": 3
},
{
"id": "EG001",
"title": "Arm II (Placebo)",
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.",
"otherNumAtRisk": 23,
"deathsNumAtRisk": 23,
"otherNumAffected": 9,
"seriousNumAtRisk": 23,
"deathsNumAffected": 0,
"seriousNumAffected": 1
}
],
"otherEvents": [
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Lymphocyte count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 3,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Neutrophil count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Back pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 10,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 3,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Peripheral sensory neuropathy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Pruritus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Rash acneiform",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Rash maculo-papular",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 7,
"numAffected": 2
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Hypertension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
}
],
"seriousEvents": [
{
"term": "Lung infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Lymphocyte count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
},
{
"term": "Rash maculo-papular",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 22,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 23,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA 12"
}
],
"frequencyThreshold": "0"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "20",
"groupId": "OG000"
},
{
"value": "20",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Minocycline Hydrochloride)",
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
},
{
"id": "OG001",
"title": "Arm II (Placebo)",
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "96.0",
"groupId": "OG000",
"lowerLimit": "54.4",
"upperLimit": "100.0"
},
{
"value": "84.3",
"groupId": "OG001",
"lowerLimit": "46.5",
"upperLimit": "99.7"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.0186",
"groupIds": [
"OG000",
"OG001"
],
"statisticalMethod": "Wilcoxon (Mann-Whitney)",
"nonInferiorityType": "SUPERIORITY_OR_OTHER"
}
],
"paramType": "MEDIAN",
"timeFrame": "Up to 12 weeks",
"description": "Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.")\nover 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.",
"unitOfMeasure": "scores on a scale",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Patients who completed the Daily Post-Paclitaxel Questionnaire item 3 over 12 weeks were included in this analysis."
},
{
"type": "PRIMARY",
"title": "Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "21",
"groupId": "OG000"
},
{
"value": "20",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Minocycline Hydrochloride)",
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
},
{
"id": "OG001",
"title": "Arm II (Placebo)",
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "94.1",
"groupId": "OG000",
"lowerLimit": "58.7",
"upperLimit": "100.0"
},
{
"value": "89.4",
"groupId": "OG001",
"lowerLimit": "68.7",
"upperLimit": "98.3"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.1146",
"groupIds": [
"OG000",
"OG001"
],
"statisticalMethod": "Wilcoxon (Mann-Whitney)",
"nonInferiorityType": "SUPERIORITY_OR_OTHER"
}
],
"paramType": "MEDIAN",
"timeFrame": "Up to course 12",
"description": "Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale.\nThe EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL).\nThe aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.\nFor example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period.\nThen these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale.",
"unitOfMeasure": "scores on a scale",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Patients who completed the EORTC Chemotherapy-Induced Peripheral Neurophathy Module Sensory Neuropathy Subscale items over 12 weeks were included in this analysis."
},
{
"type": "PRIMARY",
"title": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "21",
"groupId": "OG000"
},
{
"value": "21",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Minocycline Hydrochloride)",
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
},
{
"id": "OG001",
"title": "Arm II (Placebo)",
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "76.7",
"groupId": "OG000",
"lowerLimit": "30.8",
"upperLimit": "90.0"
},
{
"value": "59.0",
"groupId": "OG001",
"lowerLimit": "29.4",
"upperLimit": "86.4"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.0243",
"groupIds": [
"OG000",
"OG001"
],
"statisticalMethod": "Wilcoxon (Mann-Whitney)",
"nonInferiorityType": "SUPERIORITY_OR_OTHER"
}
],
"paramType": "MEDIAN",
"timeFrame": "Baseline to up to 12 weeks",
"description": "Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); "Over the past week, did you experience fatigue?") over 12 weeks.\nScores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL).\nThe aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment.",
"unitOfMeasure": "scores on a scale",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Patients who completed the Acute Pain Syndrome Summary Questionnaire over 12 weeks are included in this analysis."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm I (Minocycline Hydrochloride)",
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
},
{
"id": "FG001",
"title": "Arm II (Placebo)",
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "23"
},
{
"groupId": "FG001",
"numSubjects": "24"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "22"
},
{
"groupId": "FG001",
"numSubjects": "23"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
}
],
"dropWithdraws": [
{
"type": "Canceled",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "22",
"groupId": "BG000"
},
{
"value": "23",
"groupId": "BG001"
},
{
"value": "45",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Arm I (Minocycline Hydrochloride)",
"description": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
},
{
"id": "BG001",
"title": "Arm II (Placebo)",
"description": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "54.8",
"spread": "10.1",
"groupId": "BG000"
},
{
"value": "55.0",
"spread": "11.8",
"groupId": "BG001"
},
{
"value": "54.9",
"spread": "10.9",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "22",
"groupId": "BG000"
},
{
"value": "23",
"groupId": "BG001"
},
{
"value": "45",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "22",
"groupId": "BG000"
},
{
"value": "23",
"groupId": "BG001"
},
{
"value": "45",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
}
]
}
}
}
]