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155. A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions

Author

Janssens, A. Cecile J.W., Gwinn, Marta, Bradley, Linda A., Oostra, Ben A., van Duijn, Cornelia M., and Khoury, Muin J.

Subjects
Genomics -- Research, Health risk assessment -- Genetic aspects, Meta-analysis -- Usage, Type 2 diabetes -- Genetic aspects, Biological sciences
Abstract

The scientific advantages of using predictive genetic profiling for providing personalized nutrition and health recommendations to the consumers are presented. The commercialization of genomic profiles is found to have no scientific significance for assessing health-risks or giving personalize health interventions to the patients.

Published
2008

158. When international avatars meet: intercultural language learning in virtual reality exchange

Author

LS Spaanse letterkunde en cultuur, UiL OTS L&E, ICON - Modern and Contemporary Literature, Jauregi Ondarra, M.K., Gruber, A., Canto, S., Frederiksen, Karen-Margrete, Larsen, Sanne, Bradley, Linda, Thouësny , Sylvie, LS Spaanse letterkunde en cultuur, UiL OTS L&E, ICON - Modern and Contemporary Literature, Jauregi Ondarra, M.K., Gruber, A., Canto, S., Frederiksen, Karen-Margrete, Larsen, Sanne, Bradley, Linda, and Thouësny , Sylvie

Published
2020

159. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas

Author

Simon, James A, Al-Hendy, Ayman, Archer, David F, Barnhart, Kurt T, Bradley, Linda D, Carr, Bruce R, Dayspring, Thomas, Feinberg, Eve C, Gillispie, Veronica, Hurtado, Sandra, Kim, JinHee, Liu, Ran, Owens, Charlotte D, Muneyyirci-Delale, Ozgul, Wang, Alice, Watts, Nelson B, Schlaff, William, Simon, James A, Al-Hendy, Ayman, Archer, David F, Barnhart, Kurt T, Bradley, Linda D, Carr, Bruce R, Dayspring, Thomas, Feinberg, Eve C, Gillispie, Veronica, Hurtado, Sandra, Kim, JinHee, Liu, Ran, Owens, Charlotte D, Muneyyirci-Delale, Ozgul, Wang, Alice, Watts, Nelson B, and Schlaff, William

Abstract

Objective: To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas. Methods: Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies. Results: From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}. Conclusion: Up to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagoli

Published
2020

160. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.

Author

Schlaff, William D., Ackerman, Ronald T., Al-Hendy, Ayman, Archer, David F., Barnhart, Kurt T., Bradley, Linda D., Carr, Bruce R., Feinberg, Eve C., Hurtado, Sandra M., Kim, JinHee, Liu, Ran, Mabey, R. Garn, Owens, Charlotte D., Poindexter, Alfred, Puscheck, Elizabeth E., Rodriguez-Ginorio, Henry, Simon, James A., Soliman, Ahmed M., Stewart, Elizabeth A., Watts, Nelson B., Muneyyirci-Delale, Ozgul, Schlaff, William D., Ackerman, Ronald T., Al-Hendy, Ayman, Archer, David F., Barnhart, Kurt T., Bradley, Linda D., Carr, Bruce R., Feinberg, Eve C., Hurtado, Sandra M., Kim, JinHee, Liu, Ran, Mabey, R. Garn, Owens, Charlotte D., Poindexter, Alfred, Puscheck, Elizabeth E., Rodriguez-Ginorio, Henry, Simon, James A., Soliman, Ahmed M., Stewart, Elizabeth A., Watts, Nelson B., and Muneyyirci-Delale, Ozgul

Abstract

BACKGROUND: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding. METHODS: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal "add-back" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone group was included to assess the impact of add-back therapy on the hypoestrogenic effects of elagolix. The primary end point was menstrual blood loss of less than 80 ml during the final month of treatment and at least a 50% reduction in menstrual blood loss from baseline to the final month; missing data were imputed with the use of multiple imputation. RESULTS: A total of 412 women in UF-1 and 378 women in UF-2 underwent randomization, received elagolix or placebo, and were included in the analyses. Criteria for the primary end point were met in 68.5% of 206 women in UF-1 and in 76.5% of 189 women in UF-2 who received elagolix plus add-back therapy, as compared with 8.7% of 102 women and 10% of 94 women, respectively, who received placebo (P CONCLUSIONS: Elagolix with add-back therapy was effective in reducing heavy menstrual bleeding in women with uterine fibroids. (Funded by AbbVie; Elaris UF-1 and Elaris UF-2 ClinicalTrials.gov numbers, NCT02654054 and NCT02691494.).

Published
2020

161. Preface – CALL for widening participation

Author

Frederiksen, Karen-Margrete, Larsen, Sanne, Bradley, Linda, Thouësny, Sylvie, Frederiksen, Karen-Margrete, Larsen, Sanne, Bradley, Linda, and Thouësny, Sylvie

Published
2020

162. CALL for widening participation: short papers from EUROCALL 2020

Author

Frederiksen, Karen-Margrete, Larsen, Sanne, Bradley, Linda, Thouësny, Sylvie, Frederiksen, Karen-Margrete, Larsen, Sanne, Bradley, Linda, and Thouësny, Sylvie

Abstract

Despite the Covid-19 pandemic, the EUROCALL society succeeded in holding the 28th EUROCALL conference, EUROCALL2020, on 20-21 August as an online, two-day gathering. The transition process required to make this happen was demanding and insightful for everyone involved, and, in many ways, a logical consequence of the core content and purpose of EUROCALL. Who would be better suited to transform an onsite conference into an online event than EUROCALL? CALL for widening participation was this year’s theme. We welcomed contributions from both theoretical and practical perspectives in relation to the many forms and contexts of CALL. We particularly welcomed longitudinal studies or studies that revisited earlier studies. The academic committee accepted 300 abstracts for paper presentations, symposia, workshops, and posters under this theme; 57 short papers are published in this volume. We hope you will enjoy reading this volume, the first one to reflect a one hundred percent online EUROCALL conference/Online Gathering.

Published
2020

168. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids

Author

Al-Hendy, Ayman, primary, Bradley, Linda, additional, Owens, Charlotte D., additional, Wang, Hui, additional, Barnhart, Kurt T., additional, Feinberg, Eve, additional, Schlaff, William D., additional, Puscheck, Elizabeth E., additional, Wang, Alice, additional, Gillispie, Veronica, additional, Hurtado, Sandra, additional, Muneyyirci-Delale, Ozgul, additional, Archer, David F., additional, Carr, Bruce R., additional, Simon, James A., additional, and Stewart, Elizabeth A., additional

Published
2021
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169. Abnormal uterine bleeding

Author

Bradley, Linda D.

Subjects
Uterine bleeding -- Diagnosis, Uterine bleeding -- Care and treatment, Health
Published
2005

178. Comparison between American Indian and non-Indian out-of-home placements

Author

Donald, Karen L., Bradley, Linda K., Day, Priscilla, Critchley, Ray, and Nuccio, Kathleen E.

Subjects
Child welfare -- History, Native Americans -- Laws, regulations and rules, Government regulation, Family and marriage, Sociology and social work, Indian Child Welfare Act of 1978, Child Welfare League of America -- History
Published
2003

179. Contributors

Author

Barber, Matthew D., primary, Bradley, Linda D., additional, Diwadkar, Gouri B., additional, Escobar, Pedro F., additional, Falcone, Tommaso, additional, Jelovsek, J. Eric, additional, Paraiso, Marie Fidela R., additional, Park, Amy J., additional, Ridgeway, Beri M., additional, Tizzano, Anthony P., additional, Uranga, Rebecca S., additional, Walters, Mark D., additional, Whiteside, James L., additional, Wieder, Devorah R., additional, Chen, Chi Chiung Grace, additional, Frick, Anna C., additional, Gebhart, John B., additional, Karram, Mickey, additional, Kho, Rosanne M., additional, Magrina, Javier F., additional, and Muir, Tristi W., additional

Published
2010
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181. Contributors

Author

Abramson-Chen, Emily, primary, Agrusa, Jennifer E., additional, Aldrich, Jennifer L., additional, Ali, Asma, additional, Allison, Kelly C., additional, Antosh, Lucinda S., additional, Barsoum, Janine M., additional, Basha, Maureen E., additional, Bassaly, Renee M., additional, Belden, Katherine A., additional, Belden, Michael, additional, Berg, Dale, additional, Berg, Katherine, additional, Bienstock, Jessica L., additional, Blake, Gary D., additional, Boente, Matthew P., additional, Boswell, Stephanie B., additional, Bradley, Linda, additional, Brest, Norman A., additional, Brooks, Ari D., additional, Burke, James F., additional, Carney, Patricia I., additional, Chamchad, Dmitri, additional, Ciocca, Robin M., additional, Cook, Jonathan C., additional, Crutchlow, Michael F., additional, Curran, Diana, additional, Davenport, Deborah M., additional, Devon, Ronit K., additional, DiGiacomo III, Philip J., additional, Donnenfeld, Alan E., additional, Edelson, Mitchell I., additional, Edwards, Chad O., additional, Edwards, Michelle M., additional, Enzien, Ernest M., additional, Ferrell, Michael S., additional, Ferroni, Joseph S., additional, Fine, Sandra, additional, Finnegan, Mark O., additional, Fogel, Benjamin, additional, Gallup, Donald G., additional, Gerson, Andrew, additional, Gilbert, Brett C., additional, Gordon, Stephen E., additional, Hauge, Linnea S., additional, Heinzel, Randolph P., additional, Holtz, David, additional, Ingerman, Mark J., additional, Isaacson, Keith, additional, Isenberg, Gerald A., additional, Jacobson, Kirsten, additional, Kahn, Daron A., additional, Kakaty-Monzo, Joanne, additional, Kaplan, Richard D., additional, Keegan, Joan A., additional, Keiter, Carey L., additional, Krell, Stephen P., additional, Lande, Leah, additional, Lenhardt, Kimberly M., additional, Livornese,, Lawrence L., additional, Mann, Barry D., additional, Mann, Sara N., additional, Margolin, Gregory, additional, Maxwell, Pinckney J., additional, McCullen, Kristen M., additional, Megerian, Garo, additional, Minassian, Shahab S., additional, Miroshnichenko, Gennady G., additional, Montgomery, Benjamin E., additional, Mory, Jessica M., additional, Neofytos, Dionissios, additional, Nestel, Debra, additional, Nogami, Suzanne S., additional, Orris, John J., additional, Parva, Mehdi, additional, Peden, Gerald W., additional, Perez, Christian M., additional, Pfeffer, William H., additional, Port, Joel, additional, Robbins, Paul S., additional, Roberts, Nancy S., additional, Rosenblum, Norman G., additional, Ruiz, Camilo A., additional, Sae-Tia, Sutthichai, additional, Sagullo, Cynthia Carrole, additional, Sakhel, Khaled H., additional, Schwartz, Peter A., additional, Sciscione, Anthony C., additional, Seubert, David E., additional, Short, William R., additional, Silibovsky, Randi, additional, Smalls, Arlene, additional, Smith, Cynthia D., additional, Smith, Kaighn, additional, Squires, Kathleen E., additional, Stalburg, Caren M., additional, Stohl, Hindi E., additional, Sylvestre, Vonetta T., additional, Szymanski, Linda M., additional, Termuhlen, Paula M., additional, Toglia, Marc R., additional, Toh, Sue-Anne, additional, Tunkel, Allan R., additional, Vaughn, Beverly M., additional, Vichnin, Michelle, additional, Wadden, Thomas A., additional, Welling, Neelesh, additional, Walsh, Mary Grady, additional, White, Frank J., additional, Woodland, Mark B., additional, Yu, Anthony Lee, additional, and Zegel, Harry G., additional

Published
2010
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185. Contributors

Author

Abdelmalak, Joseph B., primary, Abelson, Abby, additional, Absi, Ahmed, additional, Achkar, Edgar, additional, Adelstein, David J., additional, Adhami, Talal, additional, Adury, Kamal, additional, Advani, Anjali, additional, Al-Ashkar, Feyrouz, additional, AlMahameed, Amjad, additional, Amado, Antoine, additional, Armogida, Sheila, additional, Armstrong, Wendy S., additional, Arroliga, Mercedes E., additional, Arroliga, Alejandro C., additional, Ashton, Kathleen, additional, Askari, Arman, additional, Atanaskova, Natasha, additional, Attaran, Marjan, additional, Aucejo, Federico, additional, Austerman, Joseph, additional, Avery, Robin, additional, Aydin, H. Nail, additional, Barnes, David, additional, Bartholomew, John R., additional, Batur, Pelin, additional, Baz, Rachid, additional, Bergfeld, Wilma, additional, Bhatt, Deepak, additional, Bharadwaj, Swati, additional, Bianchi, Laura K., additional, Boike, Allan, additional, Bolooki, Michael H., additional, Bolwell, Brian, additional, Bott-Silverman, Corinne, additional, Boyle, Andrew, additional, Bradley, Linda, additional, Braun, William E., additional, Braver, Yvonne, additional, Brener, Sorin J., additional, Brethauer, Stacy, additional, Budev, Marie M., additional, Bunyard, Matthew, additional, Burke, Carol, additional, Butt, Saud, additional, Calabrese, Leonard, additional, Camisa, Charles, additional, Caldwell, Darwin L., additional, Carey, John, additional, Carey, William D., additional, Cesario, Karin, additional, Cevasco, Nathaniel, additional, Chapman, Jeffrey T., additional, Chatterjee, Soumya, additional, Chen, Michael C., additional, Cherian, Neil, additional, Chinnappa, Priya, additional, Choure, Anuja, additional, Chung, Jeffrey Y., additional, Collins, Gregory B., additional, Covington, Edward C., additional, Culver, Daniel A., additional, Curtin, Ronan, additional, Davis, Mellar, additional, Deitcher, Steven, additional, Demirjian, Sevag, additional, Dreicer, Robert, additional, Dresing, Thomas J., additional, Dweik, Raed A., additional, Eghtesad, Bijan, additional, Elder, Julie A., additional, Embi, Peter J., additional, Englund, Kristin, additional, Erzurum, Serpil, additional, Factora, Ronan, additional, Fairbanks, Kyrsten, additional, Faith-Fernandez, Esteban, additional, Falcone, Tatiana, additional, Falcone, Tommaso, additional, Falk, Gary W., additional, Fanning, Suzanne R., additional, Fatica, Richard, additional, Fattal, Omar, additional, Faulx, Michael, additional, File, Elizabeth, additional, Fleseriu, Maria, additional, Fouad-Tarazi, Fetnat, additional, Fowler, Adele, additional, Fox, Robert, additional, Franco, Kathleen N., additional, Fraser, Thomas G., additional, Freda, Benjamin J., additional, Freeman, Katherine, additional, Fung, John J., additional, Garcia, Jorge, additional, Gildea, Thomas R., additional, Golish, Joseph A., additional, Gopinath, Anil, additional, Gordon, Steven, additional, Grandinetti, Lisa, additional, Grasso, Adam, additional, Griffin, Brian, additional, Grimm, Richard, additional, Hajj-Ali, Rula A., additional, Hall, Philip, additional, Hamrahian, Amir H., additional, Harrison, Shannon, additional, Hermida, Teresa, additional, Hernández-Rodriguez, José, additional, Heyka, Robert, additional, Hoffman, Gary S., additional, Hobbs, Robert, additional, Hong, Sandra, additional, Hoogwerf, Byron, additional, Hsieh, Fred, additional, Huang, Julie, additional, Husni, M. Elaine, additional, Ioachimescu, Adriana G., additional, Ioachimescu, Octavian C., additional, Isaacson, Harry J., additional, Isada, Carlos M., additional, Issa, Naim, additional, Jaber, Wael A., additional, Jacob, Ron, additional, Jaeger, Fredrick J., additional, Jaeger, Fred, additional, Jin, Xian Wen, additional, Juvelekian, Georges, additional, Kashyap, Sangeeta, additional, Katzan, Irene, additional, Kaur, Gurjit, additional, Kavuru, Mani, additional, Keys, Thomas F., additional, Khalife, Sami, additional, Khalil, Mazen K., additional, Khasnis, Atul, additional, Kim, Esther S.H., additional, Kim, Richard, additional, Kim, Alice, additional, Koelsch, R., additional, Koening, Curry L., additional, Kooken, Ann R., additional, Kothari, Shakuntala, additional, Krasuski, Richard A., additional, Kunkel, Robert, additional, Lakin, Milton, additional, Lang, David M., additional, LaRosa, Steven P., additional, Lascano, Martin E., additional, Lashner, Bret, additional, Leung, Anthony K., additional, Lever, Harry, additional, Lever, David S., additional, Levin, Kerry H., additional, Lichtin, Alan, additional, Lifshitz, Oren H., additional, Lim, Li Ling, additional, Logan, Daniel, additional, Lucas, Jennifer, additional, Magrey, Marina, additional, Maier, Michael, additional, Malone, Donald, additional, Manzon, Judith, additional, Maroo, Anjli, additional, Mathews, Manu, additional, Mawhorter, Steven D., additional, Mayer, Mark, additional, Mayuga, Ken, additional, Mazzone, Peter J., additional, McAllister, Mark S., additional, McCarthy, Kevin, additional, Maksimowicz-McKinnonn, Kathleen, additional, Mehta, Adi, additional, Mehta, Atul C., additional, Mekhail, Tarek, additional, Miller, Charles M., additional, Moffa, Donald, additional, Moheet, Asma, additional, Molloy, Eamonn, additional, Moore, Halle, additional, Morledge, Thomas, additional, Mossad, Sherif B., additional, Muthusamy, Preetha, additional, Muzina, David J., additional, Nair, Dileep, additional, Nally, Joseph, additional, Nasr, Christian, additional, Noeller, Thomas P., additional, Novaro, Gian M., additional, Nurko, Saul, additional, O'Shea, Robert S., additional, Padmanabhan, Ravindran, additional, Paschall, Velma L., additional, Pien, Lily C., additional, Piliang, Melissa, additional, Pimental, Ronnie, additional, Poggio, Emilio D., additional, Potts, Jeannette M., additional, Pozuelo, Leo, additional, Procop, Gary W., additional, Qadeer, Mohammed, additional, Radojicic, Christine, additional, Rafey, Mohammed, additional, Ranes, Justin L., additional, Raymond, Russell, additional, Remzi, Feza, additional, Rice, Thomas, additional, Rodriguez, Cristina, additional, Rowney, Jess, additional, Sabella, Camille, additional, Sabecks, Ronald M., additional, Sachdeva, Mandi, additional, Foldvary-Schaefer, Nancy, additional, Schauer, Philip, additional, Scheetz, Raymond, additional, Schmitt, Steven, additional, Schrieber, Martin, additional, Seballos, Raul J., additional, Schweikert, Robert A., additional, Sekeres, Mikkael A., additional, Shen, Bo, additional, Shields, Jr., Robert W., additional, Shivadas, Anita, additional, Shoemaker, Laura, additional, Shrestha, Nabin K., additional, Shrestha, Rabin K., additional, Silver, Bernard J., additional, Singh, Rishi P., additional, Singh, Vivek, additional, Skugor, Mario, additional, Smith, Stephen, additional, Soffer, Edy, additional, Solaiman, Firas Al, additional, Sood, Apra, additional, Stephany, Brian R., additional, Stevens, Tyler, additional, Stevens, Glen H.J., additional, Stoller, James K., additional, Streem, David, additional, Sweeney, Patrick, additional, Swiencicki, James F., additional, Taege, Alan, additional, Taliercio, Rachel M., additional, Tallman, Thomas, additional, Tavee, Jinny, additional, Tavill, Anthony, additional, Taylor, David, additional, Taylor, James S., additional, Tesar, George E., additional, Thacker, Holly L., additional, Theil, Karl, additional, Thornton, Sharon Longshore, additional, Tomecki, Kenneth J., additional, Tomford, Walton J., additional, Tung, Rebecca, additional, Tungsiripat, Marisa, additional, Vidimos, Allison, additional, Vogel, Nicola M., additional, Wakim-Fleming, Jamile, additional, Boon Wee, Teo, additional, Whinney, Christopher, additional, Wieckowska, Anna, additional, Wiedemann, Herbert P., additional, Wilke, William, additional, Woodhouse, Justin G., additional, Wright, Bridget, additional, Yamani, Mohamad, additional, Zanotti, Kristine, additional, Zein, Claudia O., additional, Zimmerman, Robert, additional, and Zirwas, Matthew J., additional

Published
2010
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186. Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids.

Author

Stewart, Elizabeth A., Archer, David F., Owens, Charlotte D., Barnhart, Kurt T., Bradley, Linda D., Feinberg, Eve C., Gillispie-Bell, Veronica, Imudia, Anthony N., Liu, Ran, Kim, Jin Hee, and Al-Hendy, Ayman

Subjects
STATISTICS, UTERINE fibroids, GONADOTROPIN releasing hormone, MENORRHAGIA, DATA analysis, CHEMICAL inhibitors
Abstract

Objective: To assess outcomes of women with uterine fibroids (UFs) and heavy menstrual bleeding (HMB) treated with 300 mg elagolix twice daily plus add-back therapy (E2 1 mg/NETA 0.5 mg once daily) or placebo who were not considered responders in pooled analysis of two phase 3, 6-month randomized clinical trials (Elaris UF-1 and UF-2). Methods: Responders were defined as women who met both primary end point bleeding criteria (<80 mL menstrual blood loss [MBL] during the final month and ≥50% reduction in MBL from baseline to the final month) and either completed the study or discontinued due to predefined reasons. Thus, women termed nonresponders who were analyzed in this study who met neither or one bleeding end point or met both criteria but prematurely discontinued treatment because of adverse events, perceived lack of efficacy, or required surgical or interventional treatment for UFs were analyzed in this study. This post hoc analysis assessed mean changes from baseline in MBL, as well as adverse events. Results: Among 367 women receiving elagolix with add-back with observed data, 89 (24%) were not considered responders. Within this subset, 17 (19%) women met both bleeding criteria but prematurely discontinued treatment for the reasons mentioned above, while 23 (26%) met one bleeding criterion and 49 (55%) met neither bleeding criteria, regardless of discontinuation status. Among all nonresponders, a numerical trend toward greater mean reductions in MBL was observed in those receiving elagolix with add-back, compared with placebo group nonresponders. No differences in adverse events were observed between responders and nonresponders. Conclusion: Forty of 89 (45%) women with HMB and UFs who were classified as nonresponders in the UF-1 or UF-2 trials may have had a clinically meaningful response to elagolix with add-back therapy because they met at least one of the objective bleeding criteria. Clinical Trial Registration: Clinicaltrials.gov, NCT02654054 and NCT02691494. (NEJM 2020; 382:328–340) DOI: 10.1056/NEJMoa1904351 [ABSTRACT FROM AUTHOR]

Published
2022
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199. Contributors

Author

Bradley, Linda D., primary, Falcone, Tommaso, additional, Andrews, Brenda, additional, Attaran, Marjan, additional, Bettocchi, Stefano, additional, Breitkopf, Daniel M., additional, Brill, Andrew I., additional, Ceci, Oronzo, additional, Dews, Teresa E., additional, Emery, Jonathan, additional, Farrell, Ruth M., additional, Fluharty, Sandra, additional, Goldberg, Jeffrey M., additional, Loffer, Franklin D., additional, Lukes, Andrea S., additional, Palter, Steven F., additional, Patel, Sejal Dharia, additional, Sardo, Attilio Di Spiezio, additional, and VanBlaricom, Amy, additional

Published
2009
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200. Preface

Author

BRADLEY, LINDA D., primary and FALCONE, TOMMASO, additional

Published
2009
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