mirror of
https://github.com/denoland/std.git
synced 2024-11-22 04:59:05 +00:00
381 lines
11 KiB
JSON
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,
|
|
"unit": "%",
|
|
"group": "zB",
|
|
"varType": "se",
|
|
"N": 141,
|
|
"se": 1.4,
|
|
"sd": 16.62
|
|
}
|
|
],
|
|
"time": {
|
|
"Id": 67122069,
|
|
"Low": { "Value": "Baseline" },
|
|
"High": { "Number": 12, "Unit": "wk" },
|
|
"Type": "Total",
|
|
"days": 84,
|
|
"description": "12wk"
|
|
},
|
|
"score": 2.08,
|
|
"matchingTerm": "SUF0R",
|
|
"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,
|
|
"unit": "%",
|
|
"group": "4E",
|
|
"varType": "se",
|
|
"N": 75,
|
|
"se": 2.8,
|
|
"sd": 24.25
|
|
},
|
|
{
|
|
"number": -58,
|
|
"unit": "%",
|
|
"group": "jt",
|
|
"varType": "se",
|
|
"N": 302,
|
|
"se": 1.4,
|
|
"sd": 24.33
|
|
}
|
|
],
|
|
"time": {
|
|
"Id": 67122069,
|
|
"Low": { "Value": "Baseline" },
|
|
"High": { "Number": 12, "Unit": "wk" },
|
|
"Type": "Total",
|
|
"days": 84,
|
|
"description": "12wk"
|
|
},
|
|
"score": 2.08,
|
|
"matchingTerm": "SUF0R",
|
|
"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
|
|
}
|