- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01285609
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Cape Town, 남아프리카, 7925
- Local Institution
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Durban, 남아프리카, 4067
- Local Institution
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Gauteng
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Vereeniging, Gauteng, 남아프리카, 1939
- Local Institution
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Western CAPE
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Panorama,cape Town, Western CAPE, 남아프리카, 7500
- Local Institution
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Breda, 네덜란드, 4818 CK
- Local Institution
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Harderwijk, 네덜란드, 3844 DG
- Local Institution
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Hertogenbosch, 네덜란드, 5223 GZ
- Local Institution
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Nieuwegein, 네덜란드, 3435 CM
- Local Institution
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Changhua City, 대만, 500
- Local Institution
-
Chiayi, 대만, 61363
- Local Institution
-
Kaohsiung County, 대만, 83301
- Local Institution
-
Taichung, 대만, 404
- Local Institution
-
Taichung, 대만, 407.5
- Local Institution
-
Taipei, 대만, 112
- Local Institution
-
Taipei, 대만
- Local Institution
-
Taipei City, 대만, 100
- Local Institution
-
-
-
-
-
Busan, 대한민국, 602-739
- Local Institution
-
Daegu, 대한민국, 700-712
- Local Institution
-
Gyeonggi-do, 대한민국, 463-802
- Local Institution
-
Seoul, 대한민국, 110-744
- Local Institution
-
Seoul, 대한민국, 138-736
- Local Institution
-
Seoul, 대한민국, 134-791
- Local Institution
-
Seoul, 대한민국, 135-720
- Local Institution
-
Seoul, 대한민국, 136-705
- Local Institution
-
Seoul, 대한민국, 137-701
- Local Institution
-
Seoul, 대한민국, 156-755
- Local Institution
-
Suwon, 대한민국, 443-721
- Local Institution
-
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Chungcheongbuk-do
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Cheonju-si, Chungcheongbuk-do, 대한민국, 361-771
- Local Institution
-
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, 대한민국, 410-769
- Local Institution
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Suwon-si, Gyeonggi-do, 대한민국, 442-723
- Local Institution
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Kangnam-gu
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Seoul, Kangnam-gu, 대한민국, 135-710
- Local Institution
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Seodaemungu
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Seoul, Seodaemungu, 대한민국, 120-752
- Local Institution
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-
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Aalborg, 덴마크, 9000
- Local Institution
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Herlev, 덴마크, 2730
- Local Institution
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Hillerod, 덴마크, 3400
- Local Institution
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Naestved, 덴마크, 4700
- Local Institution
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Odense, 덴마크, 5000
- Local Institution
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-
-
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Bad Berka, 독일, 99437
- Local Institution
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Bochum, 독일, 44791
- Local Institution
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Darmstadt, 독일, 64283
- Local Institution
-
Dresden, 독일, 01307
- Local Institution
-
Frankfurt Am Main, 독일, 60590
- Local Institution
-
Gauting, 독일, 82131
- Local Institution
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Grosshandsdorf, 독일, 22927
- Local Institution
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Hamburg, 독일, D-21075
- Local Institution
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Heidelberg, 독일, 69126
- Local Institution
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Kassel, 독일, 34125
- Local Institution
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Lubeck, 독일, 23538
- Local Institution
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Mainz, 독일, 55131
- Local Institution
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Muenchen, 독일, 81925
- Local Institution
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Neumunster, 독일, 24534
- Local Institution
-
Nuernberg, 독일, 90419
- Local Institution
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Regensburg, 독일, 93049
- Local Institution
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Tuebingen, 독일, 72076
- Local Institution
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Ulm, 독일, 89081
- Local Institution
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Villingen-Schwenningen, 독일, 78052
- Local Institution
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-
-
-
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Chelyabinsk, 러시아 연방, 454087
- Local Institution
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Kazan, 러시아 연방, 420029
- Local Institution
-
Moscow, 러시아 연방, 115478
- Local Institution
-
Moscow, 러시아 연방, 125009
- Local Institution
-
Pyatigorsk, 러시아 연방, 357502
- Local Institution
-
Saint Petersburg, 러시아 연방, 197758
- Local Institution
-
St-Peterburg, 러시아 연방, 198255
- Local Institution
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St. Petersburg, 러시아 연방, 197022
- Local Institution
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Tula, 러시아 연방, 300053
- Local Institution
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-
-
-
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Bucharest, 루마니아, 030171
- Local Institution
-
Bucuresti, 루마니아, 010976
- Local Institution
-
Cluj Napoca, 루마니아, 400058
- Local Institution
-
Sibiu, 루마니아, 550245
- Local Institution
-
Suceava, 루마니아, 720237
- Local Institution
-
Timisoara, 루마니아, 300239
- Local Institution
-
-
-
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Distrito Federal
-
Mexico, Distrito Federal, 멕시코, 06760
- Local Institution
-
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Jalisco
-
Zapopan, Jalisco, 멕시코, 45170
- Local Institution
-
-
Nuevo LEON
-
Monterrey, Nuevo LEON, 멕시코, 64060
- Local Institution
-
-
-
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California
-
San Diego, California, 미국, 92123
- Sharp Memorial Hospital
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Connecticut
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West Haven, Connecticut, 미국, 06516
- VA Connecticut Healthcare System
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Florida
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Boca Raton, Florida, 미국, 33486
- Lynn Cancer Institute Center For Hematology-Oncology
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Jacksonville, Florida, 미국, 32256
- Integrated Community Oncology Network
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago Medical Center
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Quincy, Illinois, 미국, 62301
- Quincy Medical Group
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Skokie, Illinois, 미국, 60076
- Presence Medical Group Hematology Oncology
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Springfield, Illinois, 미국, 62794-9678
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, 미국, 46237
- St. Francis Hospital & Health Centers
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New Albany, Indiana, 미국, 47150
- Floyd Memorial Cancer Center of Indiana
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Kentucky
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Hazard, Kentucky, 미국, 41701
- Kentucky Cancer Clinic
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Louisville, Kentucky, 미국, 40207
- Norton Cancer Institute
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Mount Sterling, Kentucky, 미국, 40353
- Montgomery Cancer Center
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Michigan
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Ypsilanti, Michigan, 미국, 48197
- St Joseph Mercy Hospital
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Missouri
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Kansas City, Missouri, 미국, 64131
- University of Kansas Cancer Center
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756-0001
- Dartmouth-Hitchcock Medical Center
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New York
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Lake Success, New York, 미국, 11042
- Clinical Research Alliance, Inc.
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North Carolina
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Durham, North Carolina, 미국, 27705
- Durham Va Medical Center (111g)
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Huntersville, North Carolina, 미국, 28078
- Carolina BioOncology Institute
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Lexington, North Carolina, 미국, 27295
- Novant Health Oncology Specialists
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Ohio
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Canton, Ohio, 미국, 44718
- Gabrail Cancer Center Research
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Oklahoma
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Tulsa, Oklahoma, 미국, 74146
- Oklahoma Oncology And Hematology, Pc Dba
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Oregon
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Portland, Oregon, 미국, 97227
- Kaiser Permanente Northwest Region
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Pennsylvania
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Sayre, Pennsylvania, 미국, 18840
- Guthrie Medical Group, P.C.
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South Carolina
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Columbia, South Carolina, 미국, 29209
- WJB Dorn VA Medical Center
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Greenville, South Carolina, 미국, 29615
- Cancer Center Of The Carolinas
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Tennessee
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Chattanooga, Tennessee, 미국, 37421
- Associated in Oncology and Hematology
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Knoxville, Tennessee, 미국, 37909
- Tennessee Cancer Specialists
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Knoxville, Tennessee, 미국, 37916
- Thompson Oncology Group
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Texas
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Austin, Texas, 미국, 78745
- Texas Oncology, PA - South Austin Cancer Center
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Virginia
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Blacksburg, Virginia, 미국, 24060
- Blue Ridge Cancer Care
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Wisconsin
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Madison, Wisconsin, 미국, 53705
- Wisconsin Institutes for Medical Research
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-
-
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Aalst, 벨기에, 9300
- Local Institution
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Liege, 벨기에, 4000
- Local Institution
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Sint Niklaas, 벨기에, 9100
- Local Institution
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Yvoir, 벨기에, 5530
- Local Institution
-
-
-
-
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Porto Alegre, 브라질, 90430
- Local Institution
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Ribeirao Preto, 브라질, 14015
- Local Institution
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Rio de Janeiro, 브라질, 20231-050
- Local Institution
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Sao Paulo, 브라질, 01224-010
- Local Institution
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Sao Paulo, 브라질, 04039-901
- Local Institution
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Ceara
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Fortaleza, Ceara, 브라질, 60160-230
- Local Institution
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Minas Gerais
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Belo Horizonte, Minas Gerais, 브라질, 30150-270
- Local Institution
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Parana
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Curitiba, Parana, 브라질, 81520-060
- Local Institution
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RIO Grande DO SUL
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Passo Fundo, RIO Grande DO SUL, 브라질, 99010260
- Local Institution
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SAO Paulo
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Barretos, SAO Paulo, 브라질, 14784
- Local Institution
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Sao Jose dos Campos, SAO Paulo, 브라질, 12245
- Local Institution
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-
-
-
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Gothenburg, 스웨덴, 413 45
- Local Institution
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Lund, 스웨덴, 221 85
- Local Institution
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Stockholm, 스웨덴, 17176
- Local Institution
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Umea, 스웨덴, SE-901 85
- Local Institution
-
-
-
-
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Basel, 스위스, 4031
- Local Institution
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Winterthur, 스위스, 8401
- Local Institution
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-
-
-
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Avila, 스페인, 05004
- Local Institution
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Benidorm-alicante, 스페인, 03501
- Local Institution
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Castellon, 스페인, 12002
- Local Institution
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Madrid, 스페인, 28041
- Local Institution
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Madrid, 스페인, 28033
- Local Institution
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Manresa, 스페인, 08243
- Local Institution
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Ourense, 스페인, 32005
- Local Institution
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Valencia, 스페인, 46014
- Local Institution
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Valencia, 스페인, 46015
- Local Institution
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Vizcaya
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Barakaldo, Vizcaya, 스페인, 48903
- Local Institution
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-
-
-
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Singapore, 싱가포르, 308433
- Local Institution
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-
-
-
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Cordoba, 아르헨티나, X5006HBF
- Local Institution
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Cordoba, 아르헨티나, X5006IKK
- Local Institution
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Mendoza, 아르헨티나, M5500AYB
- Local Institution
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Santa Fe, 아르헨티나, S3000FFU
- Local Institution
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Buenos Aires
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Quilmes, Buenos Aires, 아르헨티나, B1878DVB
- Local Institution
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Santa FE
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Rosario, Santa FE, 아르헨티나, S2000DSV
- Local Institution
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Tucuman
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San Miguel De Tucuman, Tucuman, 아르헨티나, 4000
- Local Institution
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-
-
-
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Dublin, 아일랜드, 24
- Local Institution
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Dublin, 아일랜드, 4
- Local Institution
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Dublin, 아일랜드, 8
- Local Institution
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Galway, 아일랜드
- Local Institution
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-
-
-
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Nottingham, 영국, NG51PB
- Local Institution
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Sheffield, 영국, S10 2SJ
- Local Institution
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Angus/forfarshire
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Dundee, Angus/forfarshire, 영국, DD1 9SY
- Local Institution
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Cornwall
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Truro, Cornwall, 영국, TR1 3LJ
- Local Institution
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Hampshire
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Southampton, Hampshire, 영국, SO16 6YD
- Local Institution
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-
-
-
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Graz, 오스트리아, 8036
- Local Institution
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Linz, 오스트리아, 4020
- Local Institution
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Salzburg, 오스트리아, 5020
- Local Institution
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-
-
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Beer Sheva, 이스라엘, 84101
- Local Institution
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Haifa, 이스라엘, 31096
- Local Institution
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Jerusalem, 이스라엘, 91120
- Local Institution
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Nahariya, 이스라엘, 22100
- Local Institution
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Petah-Tikva, 이스라엘, 49100
- Local Institution
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Rehovot, 이스라엘, 76100
- Local Institution
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Tel Aviv, 이스라엘, 64239
- Local Institution
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Tel-aviv, 이스라엘, 69710
- Local Institution
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Tel-hashomer, 이스라엘, 52621
- Local Institution
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Zerifin, 이스라엘, 70300
- Local Institution
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-
-
-
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Benevento, 이탈리아, 82100
- Local Institution
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Bologna, 이탈리아, 40138
- Local Institution
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Lido Di Camaiore, 이탈리아, 55041
- Local Institution
-
Lucca, 이탈리아, 55100
- Local Institution
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Monza, 이탈리아, 20052
- Local Institution
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Padova, 이탈리아, 35128
- Local Institution
-
Perugia, 이탈리아, 06156
- Local Institution
-
Siena, 이탈리아, 53100
- Local Institution
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Sondrio, 이탈리아, 23100
- Local Institution
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Terni, 이탈리아, 05100
- Local Institution
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Treviglio, 이탈리아, 24047
- Local Institution
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-
-
-
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Akashi, Hyogo, 일본, 6738558
- Local Institution
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Fukuoka, 일본, 8128582
- Local Institution
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Matsuyama, Ehime, 일본, 791-0280
- Local Institution
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Osakasayama-city, 일본, 5898511
- Local Institution
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Sapporo Hokkaido, 일본, 003-080
- Local Institution
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Sapporo, Hokkaido, 일본, 0608648
- Local Institution
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Sendai, Miyagi, 일본, 980-0873
- Local Institution
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Takatsuki, 일본, 569-8686
- Local Institution
-
Tokyo, 일본, 135-8550
- Local Institution
-
-
Aichi
-
Nagoya, Aichi, 일본, 4648681
- Local Institution
-
Nagoya-shi, Aichi, 일본, 4600001
- Local Institution
-
-
Chiba
-
Kashiwa, Chiba, 일본, 277-8577
- Local Institution
-
-
Ishikawa
-
Kanazawa-shi, Ishikawa, 일본, 9208641
- Local Institution
-
-
Kanagawa
-
Yokohama-Shi, Kanagawa, 일본, 2360051
- Local Institution
-
Yokohama-shi, Kanagawa, 일본, 2408555
- Local Institution
-
-
Miyagi
-
Natori-shi, Miyagi, 일본, 9811293
- Local Institution
-
Sendai, Miyagi, 일본, 9808574
- Local Institution
-
-
Okayama
-
Kurashiki-shi, Okayama, 일본, 7010192
- Local Institution
-
Kurashiki-shi, Okayama, 일본, 710-8602
- Local Institution
-
-
Osaka
-
Hirakata-shi, Osaka, 일본, 5731191
- Local Institution
-
Osaka-shi, Osaka, 일본, 5340021
- Local Institution
-
-
Shizuoka
-
Sunto-gun, Shizuoka, 일본, 411-8777
- Local Institution
-
-
Tokyo
-
Chuo-ku, Tokyo, 일본, 104-0045
- Local Institution
-
-
Yamaguchi
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Ube-shi, Yamaguchi, 일본, 7550241
- Local Institution
-
-
-
-
-
Beijing, 중국, 100032
- Local Institution
-
Beijing, 중국, 100071
- Local Institution
-
Beijing, 중국, 100142
- Local Institution
-
Beijing, 중국, 100853
- Local Institution
-
Santiago, 중국, 7630370
- Local Institution
-
Shanghai, 중국, 200030
- Local Institution
-
Shanghai, 중국, 200433
- Local Institution
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510060
- Local Institution
-
Guanzhou, Guangdong, 중국, 510080
- Local Institution
-
Shantou, Guangdong, 중국, 515041
- Local Institution
-
-
Hubei
-
Wuhan, Hubei, 중국, 430023
- Local Institution
-
-
Jiangsu
-
Nanjing, Jiangsu, 중국, 210002
- Local Institution
-
Nanjing, Jiangsu, 중국, 210009
- Local Institution
-
Suzhou, Jiangsu, 중국, 215006
- Local Institution
-
-
Jilin
-
Changchun, Jilin, 중국, 130012
- Local Institution
-
-
Shaanxi
-
Xi'an, Shaanxi, 중국, 710038
- Local Institution
-
Xi'an, Shaanxi, 중국, 710061
- Local Institution
-
-
Xinjiang
-
Urumqi, Xinjiang, 중국, 830011
- Local Institution
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310016
- Local Institution
-
-
-
-
-
Prague 2, 체코, 12808
- Local Institution
-
Praha 5, 체코, 150 06
- Local Institution
-
Praha 8, 체코, 180 81
- Local Institution
-
Pribram V-Zdabor, 체코, 26195
- Local Institution
-
Usti Nad Labem, 체코, 401 13
- Local Institution
-
Znojmo, 체코, 669 02
- Local Institution
-
-
Poruba
-
Ostrava, Poruba, 체코, 70852
- Local Institution
-
-
-
-
Metropolitana
-
Santiago, Metropolitana, 칠레, 7520378
- Local Institution
-
Santiago, Metropolitana, 칠레, 8380455
- Local Institution
-
-
Valparaiso
-
Vina Del Mar, Valparaiso, 칠레, 2540364
- Local Institution
-
-
-
-
-
Oshawa, 캐나다, L1G 2B9
- Local Institution
-
-
Quebec
-
Montreal, Quebec, 캐나다, H2W 1S6
- Local Institution
-
Montreal, Quebec, 캐나다, H3T 1E2
- Local Institution
-
Montreal, Quebec, 캐나다, H4J 1C5
- Local Institution
-
-
-
-
Cordoba
-
Monteria, Cordoba, 콜롬비아
- Local Institution
-
-
Risaralda
-
Pereira, Risaralda, 콜롬비아
- Local Institution
-
-
-
-
-
Bangkok, 태국, 10400
- Local Institution
-
Bangkok, 태국, 10700
- Local Institution
-
Bangkok, 태국, 10330
- Local Institution
-
Chiang Mai, 태국, 50200
- Local Institution
-
Songkhla, 태국, 90110
- Local Institution
-
-
Tungpayathai
-
Bangkok, Tungpayathai, 태국, 10400
- Local Institution
-
-
-
-
-
Arequipa, 페루
- Local Institution
-
Cercado, 페루
- Local Institution
-
Lima, 페루, LIMA 11
- Local Institution
-
-
LA Libertad
-
Trujillo, LA Libertad, 페루
- Local Institution
-
-
-
-
-
Lisboa, 포르투갈, 1099023
- Local Institution
-
Lisboa, 포르투갈, 1769-001
- Local Institution
-
Porto, 포르투갈, 4200-072
- Local Institution
-
Santa Maria Da Feira, 포르투갈, 4520211
- Local Institution
-
Vila Nova De Gaia, 포르투갈, 4434-502
- Local Institution
-
-
Coimbra
-
Sao Martinho Do Bispo, Coimbra, 포르투갈, 3041801
- Local Institution
-
-
-
-
-
Elblag, 폴란드, 82-300
- Local Institution
-
Gdansk, 폴란드, 80-952
- Local Institution
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Gdansk- Zaspa, 폴란드, 80-462
- Local Institution
-
Grudziadz, 폴란드, 86-300
- Local Institution
-
Olsztyn, 폴란드, 10-357
- Local Institution
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Otwock, 폴란드, 05-400
- Local Institution
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Poznan, 폴란드, 60 569
- Local Institution
-
Szczecin, 폴란드, 70-891
- Local Institution
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Torun, 폴란드, 87-100
- Local Institution
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Warsaw, 폴란드, 02-781
- Local Institution
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-
-
-
-
Caen Cedex 05, 프랑스, 14076
- Local Institution
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Marseille Cedex 20, 프랑스, 13915
- Local Institution
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Paris, 프랑스, 75014
- Local Institution
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Poitiers, 프랑스, 86000
- Local Institution
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Rennes Cedex 9, 프랑스, 35033
- Local Institution
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Toulouse Cedex 9, 프랑스, 31059
- Local Institution
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Vandoeuvre-les-nancy, 프랑스, 54511
- Local Institution
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-
-
-
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Budapest, 헝가리, 1121
- Local Institution
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Budapest, 헝가리, 1125
- Local Institution
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Deszk, 헝가리, 6772
- Local Institution
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Farkasgyepu, 헝가리, 8582
- Local Institution
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Gyula, 헝가리, 5703
- Local Institution
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Matrahaza, 헝가리, 3233
- Local Institution
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Nyiregyhaza, 헝가리, 4400
- Local Institution
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Pecs, 헝가리, 7602
- Local Institution
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Sopron, 헝가리, 9400
- Local Institution
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Szekesfehervar, 헝가리, 8000
- Local Institution
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Szolnok, 헝가리, 5000
- Local Institution
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South Australia
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Bedford Park, South Australia, 호주, 5042
- Local Institution
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Victoria
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Box Hill, Victoria, 호주, 3128
- Local Institution
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Frankston, Victoria, 호주, 3199
- Local Institution
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Heidelberg, Victoria, 호주, 3084
- Local Institution
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Wodonga, Victoria, 호주, 3690
- Local Institution
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-
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Hong Kong, 홍콩, 8525
- Local Institution
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Hong Kong, 홍콩
- Local Institution
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New Territories, 홍콩, 8520
- Local Institution
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Non small cell lung cancer (NSCLC) - squamous cell
- Stage IV or recurrent NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Brain Metastases
- Autoimmune diseases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Ipilimumab + Paclitaxel and Carboplatin
Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
다른 이름들:
다른 이름들:
다른 이름들:
|
위약 비교기: Placebo + Paclitaxel and Carboplatin
Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
다른 이름들:
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
기간: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
|
Overall Survival (OS) was defined as the time from randomization to the date of death.
Participants that had not died were censored at last known date alive.
Median OS time was calculated using Kaplan-Meier Estimates.
Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
|
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
기간: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
|
Overall Survival (OS) was defined as the time from randomization to the date of death.
Participants that had not died were censored at last known date alive.
Median OS time was calculated using Kaplan-Meier Estimates.
Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
|
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
|
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
기간: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
|
Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first.
A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death.
For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
|
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
위약에 대한 임상 시험
-
AJU Pharm Co., Ltd.OM Pharma SA모병
-
University Hospital, Strasbourg, France모집하지 않고 적극적으로