QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
NCT ID: NCT01231347
Last Updated: 2024-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2011-04-07
2012-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo + gemcitabine
Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Placebo
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
AMG 479 12 mg/kg dose + gemcitabine
Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
AMG 479
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
AMG 479 20 mg/kg + gemcitabine
Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
AMG 479
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
Interventions
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AMG 479
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Placebo
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
AMG 479
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate hematologic, renal and liver function
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
* Central nervous system metastases
* External biliary drain
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
NantCell, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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NantKWest Clinical Review Team
Role: PRINCIPAL_INVESTIGATOR
ImmunityBio, Inc.
Locations
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Research Site
Fullerton, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Rancho Mirage, California, United States
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Redondo Beach, California, United States
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Santa Maria, California, United States
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Chicago, Illinois, United States
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Harvey, Illinois, United States
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Quincy, Illinois, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Durham, North Carolina, United States
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Bend, Oregon, United States
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Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
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Fort Worth, Texas, United States
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Paris, Texas, United States
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Abingdon, Virginia, United States
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Spokane Valley, Washington, United States
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Kogarah, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Kurralta Park, South Australia, Australia
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Woodville South, South Australia, Australia
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Bentleigh East, Victoria, Australia
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Parkville, Victoria, Australia
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Innsbruck, , Austria
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Salzburg, , Austria
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Steyr, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Libramont, , Belgium
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Salvador, Estado de Bahia, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Vancouver, British Columbia, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Herlev, , Denmark
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Odense, , Denmark
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Lahti, , Finland
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Tampere, , Finland
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Turku, , Finland
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Brest, , France
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Clermont-Ferrand, , France
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Pessac, , France
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Berlin, , Germany
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Dresden, , Germany
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Halle, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Marburg, , Germany
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Villingen-Schwenningen, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Kowloon, , Hong Kong
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Shatin, , Hong Kong
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Tuenmen, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Miskolc, , Hungary
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Genova, , Italy
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Messina, , Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Kashiwa, Chiba, Japan
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Yokohama, Kanagawa, Japan
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Mitaka, Tokyo, Japan
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Tokyo, , Japan
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Leiden, , Netherlands
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Gdansk, , Poland
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Konin, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Barreiro, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Sibiu, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Poprad, , Slovakia
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Ljubljana, , Slovenia
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Ljubljana, , Slovenia
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Santander, Cantabria, Spain
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Badalona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Barcelona, Cataluña, Spain
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Elche, Valencia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Eskilstuna, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Geneva, , Switzerland
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Winterthur, , Switzerland
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Taipei City, Taipei, Taiwan
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Belfast, , United Kingdom
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Birmingham, , United Kingdom
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Cottingham, , United Kingdom
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Leicester, , United Kingdom
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Manchester, , United Kingdom
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Northampton, , United Kingdom
Countries
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References
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Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Related Info
Other Identifiers
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20060540
Identifier Type: -
Identifier Source: secondary_id
GAMMA
Identifier Type: -
Identifier Source: secondary_id
QUILT-2.014
Identifier Type: OTHER
Identifier Source: secondary_id
20060540
Identifier Type: -
Identifier Source: org_study_id
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