Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1440 participants
INTERVENTIONAL
2004-02-29
2007-10-31
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
NONE
Interventions
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Gefitinib
Docetaxel
Eligibility Criteria
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Inclusion Criteria
* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
* Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
* WHO performance status (PS) 0-2
* Absolute Neutrophil Count (ANC) \>1.5 x 109/liter (L) and platelets \>100 x 109/L
* Life expectancy of at least 8 weeks
Exclusion Criteria
* Prior docetaxel treatment for NSCLC
* Less than 14 days since completion of prior radiotherapy
* Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
* Evidence of clinically active Interstitial Lung Disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
* Patients with pre existing peripheral neuropathy \>= grade 2 (NCI CTC criteria)
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Iressa Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Fountain Valley, California, United States
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Los Angeles, California, United States
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Santa Rosa, California, United States
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Stockton, California, United States
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Colorado Springs, Colorado, United States
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Norwich, Connecticut, United States
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Newark, Delaware, United States
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Boca Raton, Florida, United States
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Orlando, Florida, United States
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Macon, Georgia, United States
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Tucker, Georgia, United States
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Skokie, Illinois, United States
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Knoxville, Kentucky, United States
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Saint Louis Park, Minnesota, United States
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Great Neck, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Racine, Wisconsin, United States
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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El Palomar, , Argentina
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Mar del Plata, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Charleroi, , Belgium
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Edegem, , Belgium
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Genk, , Belgium
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Godinne, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Yvoir, , Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Surrey, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Saint Catherines, Ontario, Canada
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Toronto, Ontario, Canada
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York, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Beijing, , China
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Guangzhou, , China
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Shanghai, , China
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Split, , Croatia
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Zagreb, , Croatia
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Aalborg, , Denmark
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Arhus C, , Denmark
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Glostrup Municipality, , Denmark
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Herlev, , Denmark
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København Ø, , Denmark
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Vejle, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Blois, , France
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Boulogne-Billancourt, , France
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Caen, , France
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Grenoble, , France
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Le Mans, , France
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Lille, , France
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Nantes, , France
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Niort, , France
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Saint-Herblain, , France
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Vandœuvre-lès-Nancy, , France
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Vesoul, , France
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Heidelberg, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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Cottbus, Brandenburg, Germany
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Frankfurt am Main, Hesse, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
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Berlin, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Großhansdorf, , Germany
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Leverkusen, , Germany
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Löwenstein, , Germany
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Mannheim, , Germany
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München, , Germany
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Stuttgart, , Germany
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Wiesbaden, , Germany
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Hong Kong, , Hong Kong
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Jakarta, , Indonesia
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Yogyakarta, , Indonesia
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La Torretta, Ancona, Italy
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Bari, BA, Italy
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Bergamo, BG, Italy
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Bologna, BO, Italy
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Cuneo, CN, Italy
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Catania, CT, Italy
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Forlì, FO, Italy
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Melegnano, MI, Italy
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Rozzano, MI, Italy
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Modena, MO, Italy
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Parma, PR, Italy
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Roma, Roma, Italy
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Torino, TO, Italy
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Napoli, , Italy
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Riga, , Latvia
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Kampung Baharu Nilai, , Malaysia
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Kuala Lumpur, , Malaysia
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Torreón, , Mexico
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Manila, , Philippines
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Quezon City, , Philippines
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Singapore, , Singapore
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Ljubliana, , Slovenia
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Elche, Alicante, Spain
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Barcelona, Barcelona, Spain
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Girona, Gerona, Spain
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Madrid, Madrid, Spain
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Málaga, Málaga, Spain
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Seville, Sevilla, Spain
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Valencia, Valencia, Spain
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Vitoria-Gasteiz, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Luleå, , Sweden
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Örebro, , Sweden
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Östersund, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Sundsvall, , Sweden
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Umeå, , Sweden
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Västerås, , Sweden
Research Site
Bellinzona, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
Research Site
Chiang Mai, , Thailand
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Countries
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References
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Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.
Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.
Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.
Other Identifiers
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EudraCT No: 2004-002943-28
Identifier Type: -
Identifier Source: secondary_id
1839IL/0721
Identifier Type: -
Identifier Source: secondary_id
D791GC00001
Identifier Type: -
Identifier Source: org_study_id
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