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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-3083 | Other Identifier | The GOG Foundation, Inc. | |
| ENGOT-EN20 | Other Identifier | European Network of Gynaecological Oncological Trial |
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| Name | Class |
|---|---|
| GOG Foundation | NETWORK |
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
| Belgian Gynaecological Oncology Group | OTHER |
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The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selinexor | Experimental | Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator assessed Progression Free Survival (PFS) per RECIST v1.1 | From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization to death due to any cause | Up to 34 months |
| Safety and tolerability of study drug (selinexor and placebo) | The safety and tolerability of study drug (selinexor and placebo) will be evaluated based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results, by means of the occurrence, nature, and severity of AEs via Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. |
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Inclusion Criteria: Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study:
Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible to participate in this study:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States | ||
| Honor Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40966692 | Derived | Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18. | |
| 38834399 | Derived | Makker V, Perez-Fidalgo JA, Valabrega G, Hamilton E, Van Gorp T, Sehouli J, Reginacova K, Richardson DL, Perri T, Oza AM, Miller DS, Alia EMG, De Giorgi U, Henry S, Spitz DL, Wimberger P, Bednarikova M, Chon HS, Martinez-Garcia J, Pisano C, Berek JS, Romero I, Scambia G, Farinas-Madrid L, Buscema J, Schochter F, Li K, Kalyanapu P, Walker CJ, Vergote I. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study. Gynecol Oncol. 2024 Jun;185:202-211. doi: 10.1016/j.ygyno.2024.05.016. Epub 2024 Jun 3. |
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| North Eastern German Society of Gynaecological Oncology |
| OTHER |
| The Central and Eastern European Gynecologic Oncology Group | OTHER |
| Israeli Society of Gynecologic Oncology | OTHER |
| Australia New Zealand Gynaecological Oncology Group | OTHER |
| Multicenter Italian Trials in Ovarian Cancer (MITO) | UNKNOWN |
| Grupo Español de Investigación en Cáncer de Ovario | OTHER |
| Hellenic Cooperative Oncology Group | OTHER |
| Cancer Trials Ireland (CTI) | UNKNOWN |
| Mario Negri Gynecologic Oncology group (MaNGO) | OTHER |
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Double blind placebo-controlled study
| Matching Placebo for selinexor | Drug | Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral |
|
| From start of study drug administration up to 34 months |
| Time to First Subsequent Therapy (TFST) | Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first | From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months) |
| Time to Second Subsequent Therapy (TSST) | Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first | From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months) |
| Progression-free survival after initiating a next-line treatment (PFS2) | Time from randomization until the progression event after initiating a next-line treatment or death due to any cause, whichever occurs first | From randomization until the next-line progression event or death due to any cause, up to 34 months |
| Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1 | From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months) |
| EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L) | EQ-5D-5L is a generic questionnaire that assesses health status as perceived by the patient across 5 categories (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and overall. | From baseline and at specified timepoints up to 34 months |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| UC DAVIS | Davis | California | 95616 | United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | United States |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | United States |
| UCLA - Women's Health Clinical Research Unit | Los Angeles | California | 90095 | United States |
| Long Beach Memorial Medical Center | Los Angeles | California | 90806 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| California Pacific Medical Center | San Francisco | California | 94109 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Advent Health | Orlando | Florida | 32804 | United States |
| Grady Hospital | Atlanta | Georgia | 30303 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Northwest Cancer Center | Dyer | Indiana | 46311 | United States |
| Goshen Health | Goshen | Indiana | 46526 | United States |
| St Vincent Hospital | Indianapolis | Indiana | 46260 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Our Lady of the Lake Hospital, Inc. | Baton Rouge | Louisiana | 70808 | United States |
| LSU Health Sciences Center New Orleans | New Orleans | Louisiana | 70119 | United States |
| Trials365, LLC | Shreveport | Louisiana | 71133 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| USON - Minnesota Oncology Hematology | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| St. Dominic's Gynecologic Oncology | Jackson | Mississippi | 39216 | United States |
| Midwest Ventures Group HCA MId America Division | Kansas City | Missouri | 64132 | United States |
| Intermountain Health St. Vincent Regional Hospital | Billings | Montana | 59101 | United States |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89106 | United States |
| Center Of Hope | Reno | Nevada | 89511 | United States |
| Hackensack Meridian Health Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Women's Cancer Care Associates, LLC | Albany | New York | 12208 | United States |
| NYU Langone Hospital-Long Island | Mineola | New York | 11501 | United States |
| Northwell Health - Zuckerberg Cancer Center | New Hyde Park | New York | 11042 | United States |
| Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Northwell Health - Queens Cancer Center | Rego Park | New York | 11374 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Atrium Health Levine Cancer Institute | Charlotte | North Carolina | 28209 | United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| MetroHealth | Cleveland | Ohio | 44109 | United States |
| Zangmeister Cancer Center | Columbus | Ohio | 43219 | United States |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Cancer Specialists and Research Institute, LLC | Tulsa | Oklahoma | 74146 | United States |
| Oncology Associates of Oregon | Eugene | Oregon | 97401 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Alliance Cancer Specialists | Langhorne | Pennsylvania | 19047 | United States |
| Magee - Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Allegheny Health Network - West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Avera | Sioux Falls | South Dakota | 57105 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38103 | United States |
| USON - Texas Oncology, Austin Central | Austin | Texas | 78731 | United States |
| Parkland Health & Hospital System | Dallas | Texas | 75235 | United States |
| Texas Oncology - Dallas | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Texas Oncology - San Antonio | San Antonio | Texas | 78240 | United States |
| Texas Oncology - The Woodlands | The Woodlands | Texas | 77380 | United States |
| Texas Oncology, PC, Tyler | Tyler | Texas | 75702 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Border Medical Oncology & Haematology | Albury | New South Wales | 2640 | Australia |
| Macarthur Cancer Therapy Centre | Campbelltown | New South Wales | 2560 | Australia |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Central Coast LHD - Gosford & Wyong Hospitals | Gosford | New South Wales | 2250 | Australia |
| Newcastle Private Hospital | New Lambton Heights | New South Wales | 2305 | Australia |
| Royal North Shore Hospital | Saint Leonards | New South Wales | Australia |
| Westmead Hospital | Wentworthville | New South Wales | 2145 | Australia |
| ICON Cancer Centre Southport | Southport | Queensland | 4215 | Australia |
| Toowoomba Hospital | Toowoomba | Queensland | 4350 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Box Hill Hospital - Eastern Health (Oncology) | Box Hill | Victoria | 3128 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| Cabrini Health | Malvern | Victoria | 3144 | Australia |
| The Royal Adelaide Hospital | Southport | 5000 | Australia |
| Cliniques Universitaires St. Luc | Brussels | 1200 | Belgium |
| AZ Sint Lucas | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU Ambroise Pare | Mons | 7000 | Belgium |
| CHU UCL Namur, Site Sainte-Elisabeth | Namur | 5000 | Belgium |
| Tom Baker Cancer Centre | Calgary | Alberta | T3H2G5 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Nova Scotia Health / QEII Health Sciences Centre / Atlantic Clinical Cancer Research Unit | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Princess Margaret | Toronto | Ontario | M5G 2M9 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | M9L 2H9 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 0C1 | Canada |
| McGill University Health Centre (MUHC) | Montreal | Quebec | H4A3J1 | Canada |
| Hospital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| University Hospital Brno | Brno | 60200 | Czechia |
| University Hospital Ostrava | Ostrava | 70852 | Czechia |
| UH Královské Vinohrady | Prague | 10034 | Czechia |
| General University Hospital in Prague | Prague | 12851 | Czechia |
| Hospital Na Bulovce | Prague | 18100 | Czechia |
| High Technology Hospital Medcenter | Batumi | 6000 | Georgia |
| Todua Clinic | Tbilisi | 0112 | Georgia |
| LTD New Hospitals | Tbilisi | 0114 | Georgia |
| Tbilisi Cancer Center | Tbilisi | 0156 | Georgia |
| JSC - K.Eristavi National Center of Experimental and Clinical Surgery | Tbilisi | 0159 | Georgia |
| Caucasus Medical Centre | Tbilisi | 0186 | Georgia |
| LTD Innova Medical Center | Tbilisi | 0186 | Georgia |
| Multiprofile Clinic "Consilium Medulla" | Tbilisi | 0186 | Georgia |
| Charite Berlin Universitatsmedizin | Berlin | 13353 | Germany |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| University Hospital Dresden | Kiel | 01307 | Germany |
| Universitatsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Helios Klinikum Krefeld | Krefeld | 47805 | Germany |
| Universitätsklinik Leipzig | Leipzig | 04103 | Germany |
| Universitätsfrauenklinik Mainz | Mainz | 55131 | Germany |
| Universitätsmedizin Mannheim | Mannheim | 68167 | Germany |
| Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern | Munich | 80337 | Germany |
| Klinikum Südstadt Rostock | Rostock | 18059 | Germany |
| Universitätsfrauenklinik Ulm | Ulm | 89075 | Germany |
| IASO Hospital | Marousi | Athens | 151 23 | Greece |
| Alexandra Hospital | Athens | 11528 | Greece |
| Hygeia Hospital | Athens | 15123 | Greece |
| Euromedica General Clinic | Thessaloniki | 54645 | Greece |
| Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen | Debrecen | 4032 | Hungary |
| Petz Aladár University Teaching Hospital | Győr | 9024 | Hungary |
| St. Vincent's University Hospital | Dublin | Elm Park | D04 T6F4 | Ireland |
| Cork University Hospital | Cork | T12 DC4A | Ireland |
| St. James Hospital | Dublin | D08 NHY1 | Ireland |
| Galway University | Galway | H91 YR71 | Ireland |
| University Hospital Waterford | Waterford | X91 ER8E | Ireland |
| Hillel-Yaffe Medical Center | Hadera | 38100 | Israel |
| Wolfson Medical Center | Holon | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| IRCCS Azienda Ospedaliero Universitaria di Bologna | Bologna | 40138 | Italy |
| ASST Spedali Civili Di Brescia | Brescia | 25123 | Italy |
| IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L. | Meldola | 47014 | Italy |
| San Raffaele Hospital | Milan | 20132 | Italy |
| Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica | Milan | 20133 | Italy |
| Instituto Europeo di Oncologia | Milan | 20141 | Italy |
| Humanitas San Pio X Hospital | Milan | 20159 | Italy |
| Ospedale San Gerardo - Asst Monza | Monza | 20900 | Italy |
| "Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica" | Naples | 20133 | Italy |
| Istituto Oncologico Veneto | Padova | 35128 | Italy |
| Universita di Pisa | Pisa | 56127 | Italy |
| Nuovo Ospedale di Prato | Prato | 59100 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli - ROMA | Roma | 00168 | Italy |
| Ospedale Ostetrico Ginecologico Sant'Anna | Torino | 10124 | Italy |
| AO Ordine Mauriziano | Torino | 10128 | Italy |
| St. Elisabeth Cancer Institute | Bratislava | 81250 | Slovakia |
| UH Bratislava | Bratislava | 82606 | Slovakia |
| National Cancer Institute | Bratislava | 83310 | Slovakia |
| UH Trenčín | Trenčín | 91101 | Slovakia |
| Soon Chun Hyang University Hospital Cheonan | Cheonan | Chungcheongnam-do | 31151 | South Korea |
| Severance Hospital (Yonsei University Health System) | Seoul | Seongbuk | 50-1 | South Korea |
| Samsung Changwon Hospital | Changwon | 51353 | South Korea |
| National Cancer Center (NCC) | Goyang-si | 323 | South Korea |
| CHA University/Bundang CHA General Hospital | Seongnam-si | 59 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Seoul National University Bundang Hospital | Seoul | 101 | South Korea |
| Korea University Anam Hospital | Seoul | 73 | South Korea |
| Asan Medical Center | Seoul | 88 | South Korea |
| Hospital Universitario Donostia | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
| Hospital Clínico Universitario Lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |
| ICO Badalona | Badalona | 08916 | Spain |
| Hospital Universitari Vall d' Hebrón | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Institut Catala d'Oncologia Hospitalet | Barcelona | 08908 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Institut Catala d'Oncologia de Girona | Girona | 17007 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| MD Anderson Cancer Center Madrid | Madrid | 28033 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| H 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitatrio Virgen de la Victoria | Málaga | 29010 | Spain |
| Virgen de la Arrixaca University Clinical Hospital | Murcia | 30120 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital LaFe Uacenlia | Valencia | 46026 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833401 | Taiwan |
| TaiChung Veterans General Hospital | Taichung | 407219 | Taiwan |
| Chi Mei Medical Center | Tainan | 71004 | Taiwan |
| Mackay Memorial Hospital | Taipei | 104217 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare | Taipei | 23561 | Taiwan |
| Chang Gung Memorial Hospital | Taoyuan City | 333 | Taiwan |
| Ankara Baskent Hospital | Çankaya | Ankara | 34093 | Turkey (Türkiye) |
| Çukurova University | Adana | 01330 | Turkey (Türkiye) |
| Adana Baskent Hospital | Adana | 34920 | Turkey (Türkiye) |
| Hacettepe University Oncology Hospital | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hospital | Ankara | 06520 | Turkey (Türkiye) |
| Cerrahpasa University | Istanbul | 34098 | Turkey (Türkiye) |
| Acibadem Atakent Hospital | Istanbul | 34303 | Turkey (Türkiye) |
| 38627035 | Derived | Vergote I, Perez Fidalgo A, Valabrega G, Monk BJ, Herzog T, Cibula D, Colombo N, Pothuri B, Sehouli J, Korach J, Barlin J, Papadimitriou CA, van Gorp T, Richardson D, McCarthy M, Antill Y, Mirza MR, Li K, Kalyanapu P, Slomovitz B, Coleman RL. ENGOT-EN20/GOG-3083/XPORT-EC-042 - A phase III, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced, or recurrent endometrial carcinoma: rationale, methods, and trial design. Int J Gynecol Cancer. 2024 Aug 5;34(8):1283-1289. doi: 10.1136/ijgc-2024-005412. |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
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| ID | Term |
|---|---|
| C585161 | selinexor |
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