std/msgpack/testdata/4.json
2023-07-10 12:09:49 +09:00

381 lines
11 KiB
JSON

{
"metadata": {
"Designs": ["Randomized Controlled Trial"],
"Types": [],
"BriefSummary": "To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4\n weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The\n dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a\n calibrator.",
"Abstract": "To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4\n weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The\n dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a\n calibrator.",
"Acronym": null,
"ArticleId": "Qy3gwKWSoaWRmbmFEQA",
"Authors": null,
"CochraneID": null,
"Confidential": false,
"CorporateAuthor": null,
"Country": "Bulgaria, Canada, Hungary, Israel, Norway, Slovakia, United Kingdom, United States",
"CustomData": null,
"DatabaseType": "ClinicalTrials.gov",
"DOI": null,
"EmbaseAccessionNumber": null,
"Emtree": null,
"ErrataText": null,
"FullTextURL": null,
"Institution": null,
"ISSN": null,
"Issue": null,
"JournalTitle": null,
"MedlineID": null,
"MeSH": "Hypercholesterolemia|Antibodies, Monoclonal",
"Pages": null,
"ParentChildStatus": null,
"ParentID": null,
"PublicationDate": "March 21, 2017",
"PublicationYear": 2017,
"PubType": null,
"ReferenceStudy": null,
"SecondarySourceID": null,
"Source": "Regeneron Pharmaceuticals",
"SourceReferenceId": "NCT01926782",
"TaStudyDesign": "Randomized",
"Title": "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia",
"TrialOutcome": null,
"Volume": null,
"Id": 179246831,
"Created": "2020-04-10T14:48:20.4384957Z",
"VersionNo": 2,
"ExtractData": null,
"Digitized": true,
"IsRapidExtract": false,
"IsUploaded": false
},
"design": "Randomized Controlled Trial",
"conditions": [{ "label": "Cholesterol Total Increased", "id": "SUE_c" }],
"phase": 3,
"name": "NCT01926782",
"trialIds": ["NCT01926782"],
"acronyms": [],
"outcomeCount": 156,
"id": 179246831,
"groups": [
{
"Id": "4r",
"RefId": "B5|O2~Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin",
"OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin",
"N": 37,
"age": 59.3,
"ageSD": 11.3,
"male": 37.83783783783784,
"Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"], ["SUNUVb"]] }],
"analyzeAs": "Alirocumab",
"analyzableScore": 1.0717734625362931,
"matchingScore": 0
},
{
"Id": "zB",
"RefId": "B6|O3~Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin",
"OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin",
"N": 146,
"age": 59.2,
"ageSD": 10.8,
"male": 45.205479452054796,
"Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"]] }],
"analyzeAs": "Statins",
"analyzableScore": 1.0717734625362931,
"matchingScore": 0
},
{
"Id": "3!",
"RefId": "B4|O1~Placebo Q2W Without Concomitant Statin",
"OriginalName": "Placebo Q2W Without Concomitant Statin",
"N": 73,
"age": 59.4,
"ageSD": 10.2,
"male": 54.794520547945204,
"Interventions": [{ "termIds": [["SUGeLS"], ["SUBYEL", "SUB_Oc"]] }],
"analyzeAs": "Control",
"analyzableScore": 1.2020833333333334,
"matchingScore": 0
},
{
"Id": "tv",
"RefId": "E3",
"OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W",
"Interventions": [{ "termIds": [["SUCO54", "SUNUVb"]] }]
},
{
"Id": "jt",
"RefId": "B3|O3~Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin",
"OriginalName": "Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin",
"N": 312,
"age": 61.6,
"ageSD": 10,
"male": 60.8974358974359,
"Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"]] }]
},
{
"Id": "5!",
"RefId": "E2",
"OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W",
"Interventions": [{ "termIds": [["SUNUVb"]] }]
},
{
"Id": "4E",
"RefId": "B2|O2~Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin",
"OriginalName": "Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin",
"N": 78,
"age": 60.7,
"ageSD": 9.1,
"male": 65.38461538461539,
"Interventions": [{ "termIds": [["SUBYEL", "SUB_Oc"], ["SUNUVb"]] }]
},
{
"Id": "i4",
"Interventions": [
{
"Id": "Ya",
"Name": 178613599,
"Treatments": [{ "Id": "((", "Phase": "k)" }],
"Type": "Drug",
"termIds": [["SUGeLS"], ["SUNUVb"]],
"terms": [["Placebo"], ["Alirocumab"]]
},
{
"Id": "o)",
"Name": 2159990,
"Treatments": [{ "Id": "1$", "Phase": "k)" }],
"Type": "Drug",
"termIds": [["SUBYEL"]],
"terms": [["Statins"]]
}
],
"RefId": "E1|Placebo Q2W",
"OriginalName": "Placebo Q2W"
},
{
"Id": "Ls",
"RefId": "B1|O1~Placebo Q2W With Concomitant Statin",
"OriginalName": "Placebo Q2W With Concomitant Statin",
"N": 157,
"age": 61.6,
"ageSD": 9.7,
"male": 64.3312101910828,
"Interventions": [{ "termIds": [["SUGeLS"], ["SUBYEL", "SUB_Oc"]] }]
}
],
"hasDocData": true,
"hasRapidExtract": false,
"N": 803,
"queryScore": 1.4868329805051381,
"matchingScore": 7.960635921410255,
"score": 22.084654254966498,
"outcomes": [
{
"id": "179246387",
"type": "Change",
"unit": "%",
"termIds": [["SUF0R", "SUBskP"]],
"quantifiers": [],
"name": "Calculated LDL-C in Not Receiving Concomitant Statin Therapy - On-Treatment Analysis",
"cells": [
{
"number": -0.4,
"unit": "%",
"group": "3!",
"varType": "se",
"N": 70,
"se": 2,
"sd": 16.73
},
{
"number": -54.6,
"unit": "%",
"group": "4r",
"varType": "se",
"N": 37,
"se": 2.8,
"sd": 17.03
},
{
"number": -59.4,
"unit": "%",
"group": "zB",
"varType": "se",
"N": 141,
"se": 1.4,
"sd": 16.62
}
],
"time": {
"Id": 67122072,
"Low": { "Value": "Baseline" },
"High": { "Number": 24, "Unit": "wk" },
"Type": "Total",
"days": 168,
"description": "24wk"
},
"score": 2.08,
"matchingTerm": "SUF0R",
"suggestedPositive": false,
"sourceUnit": "%"
},
{
"id": "179246389",
"type": "Change",
"unit": "%",
"termIds": [["SUF0R", "SUBskP"]],
"quantifiers": [],
"name": "Calculated LDL-C in Receiving Concomitant Statin Therapy - On-Treatment Analysis",
"cells": [
{
"number": -0.3,
"unit": "%",
"group": "Ls",
"varType": "se",
"N": 151,
"se": 2.1,
"sd": 25.81
},
{
"number": -55.1,
"unit": "%",
"group": "4E",
"varType": "se",
"N": 75,
"se": 3,
"sd": 25.98
},
{
"number": -62.3,
"unit": "%",
"group": "jt",
"varType": "se",
"N": 302,
"se": 1.5,
"sd": 26.07
}
],
"time": {
"Id": 67122072,
"Low": { "Value": "Baseline" },
"High": { "Number": 24, "Unit": "wk" },
"Type": "Total",
"days": 168,
"description": "24wk"
},
"score": 2.08,
"matchingTerm": "SUF0R",
"suggestedPositive": false,
"sourceUnit": "%"
},
{
"id": "179246393",
"type": "Change",
"unit": "%",
"termIds": [["SUF0R", "SUBskP"]],
"quantifiers": [],
"name": "Calculated LDL-C in Not Receiving Concomitant Statin Therapy - On-Treatment Analysis",
"cells": [
{
"number": -0.5,
"unit": "%",
"group": "3!",
"varType": "se",
"N": 70,
"se": 2,
"sd": 16.73
},
{
"number": -53.9,
"unit": "%",
"group": "4r",
"varType": "se",
"N": 37,
"se": 2.7,
"sd": 16.42
},
{
"number": -60,
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"group": "zB",
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"se": 1.4,
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}
],
"time": {
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"Low": { "Value": "Baseline" },
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"Type": "Total",
"days": 84,
"description": "12wk"
},
"score": 2.08,
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"suggestedPositive": false,
"sourceUnit": "%"
},
{
"id": "179246394",
"type": "Change",
"unit": "%",
"termIds": [["SUF0R", "SUBskP"]],
"quantifiers": [],
"name": "Calculated LDL-C in Receiving Concomitant Statin Therapy - On-Treatment Analysis",
"cells": [
{
"number": 1.4,
"unit": "%",
"group": "Ls",
"varType": "se",
"N": 151,
"se": 1.9,
"sd": 23.35
},
{
"number": -47.3,
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"se": 2.8,
"sd": 24.25
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{
"number": -58,
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"se": 1.4,
"sd": 24.33
}
],
"time": {
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"Low": { "Value": "Baseline" },
"High": { "Number": 12, "Unit": "wk" },
"Type": "Total",
"days": 84,
"description": "12wk"
},
"score": 2.08,
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"suggestedPositive": false,
"sourceUnit": "%"
}
],
"characteristics": [
{
"id": "179246354",
"type": "Binary",
"isCharacteristic": true,
"termIds": [["SUE_c", "SUCbN", "SUyJj"]],
"quantifiers": [],
"name": "Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk",
"cells": [],
"number": 100
}
],
"outcomesScore": 18.97947630112307
}