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1. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures

Author

Bui, Cat, Emechebe, Nnadozie, Kamalakar, Rajesh, Papadopoulos, Elektra, Sail, Kavita, Sen, Rohini, Turner, Sean C, Cocks, Kim, Reijneveld, Jaap, Gerlinger, Christoph, Keating, Karen, Su, Yun, Wolf, Birgit, Ge, Miaomiao, Ingelgaard, Anders, Peil, Barbara, Voorhaar, Maarten, Wong, Brendon, Dekanic Arbanas, Gracia, Kuljanic, Karin, Petranovic, Duska, Rede, Ivana, Arraras, Juan, Coons, Stephen Joel, Eremenco, Sonya, Murray, Lindsey, Reeve, Bryce, De Vries, Corinne, Herold, Ralf, Pignatti, Francesco, Machingura, Abigirl, Martinelli, Francesca, Musoro, Jammbe, Piccart, Martine, Barriuso, Jorge, Cherny, Nathan, Dafni, Ourania, De Vries, Elisabeth, Gyawali, Bishal, Kiesewetter, Barbara, Oosting, Sjoukje, Roitberg, Felipe, Rumpold, Gerhard, Schoepf, Felix, Tschuggnall, Michael, Black, Jennifer, Sasseville, Maxime, Soltys, Katherine, Ferrer, Montserrat, Garin, Olatz, Vilagut, Gemma, Schürmann, Christoph, Thomas, Stefanie, Wieseler, Beate, Snyder, Claire, Alonso Abad, Ariel, Bogaerts, Kris, Brackx, Febe, Molenberghs, Geert, Verbeke, Geert, Frigolett Catalan, Cristián, Choi, Jan, Thomassen, Doranne, Geissler, Jan, Sauerbrei, Willi, Gross, Franziska, Pilz, Micha Johannes, Barbachano, Yolanda, Campbell, Lisa, Rantell, Khadija, Desplanques, Gregoire, Regnault, Antoine, Morgan, Kate, Plate, Ananda, ten Seldam, Silene, Terada, Mitsumi, Mizusawa, Junki, Mitchell, Sandra, Wilder Smith, Ashley, Reksten, Tove Ragna, Schiel, Anja, Hansen Joseph, Kenth Louis, Campbell, Alicyn, Cappelleri, Joseph, de Besi, Patrizia, Russell-Smith, Alexander, Sandin, Rickard, Mamolo, Carla, Brundage, Michael, Tu, Dongsheng, Groenvold, Mogens, Petersen, Morten, Cleeland, Charlie, Williams, Lori, Shelley Wang, Xin, Ringash, Jolie, Calvert, Melanie, Cruz Rivera, Samantha, Aiyegbusi, Olalekan Lee, Goetghebeur, Els, Liu, Limin, Van Lancker, Kelly, Boele, Florien, Gilbert, Alexandra, Peacock, Rosemary, Basch, Ethan, King, Madeleine, Rutherford, Claudia, Bhatnagar, Vishal, Fiero, Mallorie, Horodniceanu, Erica, Johnson, Laura Lee, Kluetz, Paul, Rodriguez, Lisa, Pe, Madeline, Alanya, Ahu, Falk, Ragnhild Sorum, Amdal, Cecilie Delphin, Bjordal, Kristin, Chang, Jane, Cislo, Paul, Coens, Corneel, Dirven, Linda, Speck, Rebecca M, Fitzgerald, Kristina, Galinsky, Jayne, Giesinger, Johannes M, Holzner, Bernhard, Le Cessie, Saskia, O'Connor, Daniel, Oliver, Kathy, Pawar, Vivek, Quinten, Chantal, Schlichting, Michael, Ren, Jinma, Roychoudhury, Satrajit, Taphoorn, Martin J B, Velikova, Galina, Wintner, Lisa M, Griebsch, Ingolf, and Bottomley, Andrew

Published
2023
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5. Patient-reported outcomes in the phase 3 BFORE trial of bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia

Author

Cortes, Jorge E., Gambacorti-Passerini, Carlo, Deininger, Michael W., Mauro, Michael J., Chuah, Charles, Kim, Dong-Wook, Milojkovic, Dragana, le Coutre, Philipp, Garcia-Gutierrez, Valentin, Crescenzo, Rocco, Mamolo, Carla, Reisman, Arlene, Hochhaus, Andreas, Brümmendorf, Tim H., and the BFORE Study Investigators

Published
2019
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6. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures

Author

Pe, Madeline, primary, Alanya, Ahu, additional, Falk, Ragnhild Sorum, additional, Amdal, Cecilie Delphin, additional, Bjordal, Kristin, additional, Chang, Jane, additional, Cislo, Paul, additional, Coens, Corneel, additional, Dirven, Linda, additional, Speck, Rebecca M, additional, Fitzgerald, Kristina, additional, Galinsky, Jayne, additional, Giesinger, Johannes M, additional, Holzner, Bernhard, additional, Le Cessie, Saskia, additional, O'Connor, Daniel, additional, Oliver, Kathy, additional, Pawar, Vivek, additional, Quinten, Chantal, additional, Schlichting, Michael, additional, Ren, Jinma, additional, Roychoudhury, Satrajit, additional, Taphoorn, Martin J B, additional, Velikova, Galina, additional, Wintner, Lisa M, additional, Griebsch, Ingolf, additional, Bottomley, Andrew, additional, Bui, Cat, additional, Emechebe, Nnadozie, additional, Kamalakar, Rajesh, additional, Papadopoulos, Elektra, additional, Sail, Kavita, additional, Sen, Rohini, additional, Turner, Sean C, additional, Cocks, Kim, additional, Reijneveld, Jaap, additional, Gerlinger, Christoph, additional, Keating, Karen, additional, Su, Yun, additional, Wolf, Birgit, additional, Ge, Miaomiao, additional, Ingelgaard, Anders, additional, Peil, Barbara, additional, Voorhaar, Maarten, additional, Wong, Brendon, additional, Dekanic Arbanas, Gracia, additional, Kuljanic, Karin, additional, Petranovic, Duska, additional, Rede, Ivana, additional, Arraras, Juan, additional, Coons, Stephen Joel, additional, Eremenco, Sonya, additional, Murray, Lindsey, additional, Reeve, Bryce, additional, De Vries, Corinne, additional, Herold, Ralf, additional, Pignatti, Francesco, additional, Machingura, Abigirl, additional, Martinelli, Francesca, additional, Musoro, Jammbe, additional, Piccart, Martine, additional, Barriuso, Jorge, additional, Cherny, Nathan, additional, Dafni, Ourania, additional, De Vries, Elisabeth, additional, Gyawali, Bishal, additional, Kiesewetter, Barbara, additional, Oosting, Sjoukje, additional, Roitberg, Felipe, additional, Rumpold, Gerhard, additional, Schoepf, Felix, additional, Tschuggnall, Michael, additional, Black, Jennifer, additional, Sasseville, Maxime, additional, Soltys, Katherine, additional, Ferrer, Montserrat, additional, Garin, Olatz, additional, Vilagut, Gemma, additional, Schürmann, Christoph, additional, Thomas, Stefanie, additional, Wieseler, Beate, additional, Snyder, Claire, additional, Alonso Abad, Ariel, additional, Bogaerts, Kris, additional, Brackx, Febe, additional, Molenberghs, Geert, additional, Verbeke, Geert, additional, Frigolett Catalan, Cristián, additional, Choi, Jan, additional, Thomassen, Doranne, additional, Geissler, Jan, additional, Sauerbrei, Willi, additional, Gross, Franziska, additional, Pilz, Micha Johannes, additional, Barbachano, Yolanda, additional, Campbell, Lisa, additional, Rantell, Khadija, additional, Desplanques, Gregoire, additional, Regnault, Antoine, additional, Morgan, Kate, additional, Plate, Ananda, additional, ten Seldam, Silene, additional, Terada, Mitsumi, additional, Mizusawa, Junki, additional, Mitchell, Sandra, additional, Wilder Smith, Ashley, additional, Reksten, Tove Ragna, additional, Schiel, Anja, additional, Hansen Joseph, Kenth Louis, additional, Campbell, Alicyn, additional, Cappelleri, Joseph, additional, de Besi, Patrizia, additional, Russell-Smith, Alexander, additional, Sandin, Rickard, additional, Mamolo, Carla, additional, Brundage, Michael, additional, Tu, Dongsheng, additional, Groenvold, Mogens, additional, Petersen, Morten, additional, Cleeland, Charlie, additional, Williams, Lori, additional, Shelley Wang, Xin, additional, Ringash, Jolie, additional, Calvert, Melanie, additional, Cruz Rivera, Samantha, additional, Aiyegbusi, Olalekan Lee, additional, Goetghebeur, Els, additional, Liu, Limin, additional, Van Lancker, Kelly, additional, Boele, Florien, additional, Gilbert, Alexandra, additional, Peacock, Rosemary, additional, Basch, Ethan, additional, King, Madeleine, additional, Rutherford, Claudia, additional, Bhatnagar, Vishal, additional, Fiero, Mallorie, additional, Horodniceanu, Erica, additional, Johnson, Laura Lee, additional, Kluetz, Paul, additional, and Rodriguez, Lisa, additional

Published
2023
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17. Humanistic and Economic Burden of Non-Muscle Invasive Bladder Cancer: Results of Two Systematic Literature Reviews

Author

Lee, Lauren J, Kwon, Christina S, Forsythe, Anna, Mamolo, Carla M, Masters, Elizabeth T, and Jacobs, Ira A

Subjects
health-related quality of life, symptoms, costs, Review, NMIBC
Abstract

Purpose Non-muscle invasive bladder cancer (NMIBC) is a malignancy restricted to the inner lining of the bladder. Intravesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor is the mainstay first-line treatment for high-risk NMIBC patients. Two systematic literature reviews (SLRs) were conducted to further assess the current evidence on BCG use in NMIBC and the humanistic and economic burden of disease. Methods Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, Embase® and MEDLINE® were searched using the Ovid platform to identify interventional or real-world evidence studies on the health-related quality of life (HRQoL) and economic burden in NMIBC. Limited evidence was found from initial economic SLR searches in NMIBC, so additional targeted searches for bladder cancer were conducted to expand findings. Results Fifty-nine publications were included in the HRQoL SLR, of which 23 reported HRQoL and symptoms in NMIBC. At diagnosis, HRQoL was comparable with population norms but worsened considerably 2 years following diagnosis. Maintenance therapy with intravesical BCG was associated with reduced HRQoL, and treatment-related adverse events (AEs) resembled typical NMIBC symptoms. Twenty-two studies reported decreasing BCG compliance over time. Common AEs with BCG were frequent urination, lower urinary tract symptoms, pain, and hematuria. Forty-two publications were included in the economic SLR, of which nine assessed healthcare costs and resource use in NMIBC or bladder cancer. High-risk disease and high-intensity treatment were associated with increased healthcare costs. Conclusion NMIBC has a considerable symptomatic, HRQoL, and economic burden. Symptoms persisted and HRQoL worsened despite intravesical BCG treatment. NMIBC is a costly disease, with higher healthcare costs associated with increased risk of disease progression and recurrence. There is a high unmet need for safe and effective treatments that reduce the risk of disease progression and recurrence, provide symptomatic relief, and improve HRQoL for patients.

Published
2020

23. The Performance of Left-Handed Participants on a Preferential Reaching Test

Author

Mamolo, Carla M., Roy, Eric A., and Bryden, Pamela J.

Abstract

Previous research in our laboratory has examined the distribution of preferred hand (PH) reaches in working space with right-handed participants. In one study, we examined the effects of tool position and task demands on the frequency of PH reaches with right-handers (Mamolo, Roy, Bryden, & Rohr, 2004). We found that PH reaches were at a maximum within ipsilateral space, and predominated within contralateral space. This was mediated by the task demands, as shown by an increased frequency of PH reaches for the more skill demanding tasks. In the current study, we tested left-handed participants on the same procedure. Five different tools were placed in an array in front of the participant, who was required to reach for, and perform one of three tasks with the tool: Lift the tool; lift and Pantomime its use; or lift and Use the tool on its corresponding object. The results showed that PH reaches were at a maximum within ipsilateral space for all three tasks. Significantly fewer PH reaches were made for tools in contralateral space. In particular, almost no PH reaches were made for the Lift task at the most extreme contralateral position. This indicates the willingness of left-handers to use their non-preferred (i.e., right) hand. One possible explanation supported by these results is that left-handers have adapted to an environment designed for right-handers. (Contains 1 figure.)

Published
2005
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24. The Effects of Skill Demands and Object Position on the Distribution of Preferred Hand Reaches

Author

Mamolo, Carla M., Roy, Eric A., and Bryden, Pamela J.

Abstract

Performance-based measures of hand preference have been developed as an objective method of examining handedness. Previous research using this method by Bryden, Roy, and Mamolo (2003) showed that both skill demands and the position of the object in working space affect preferential hand reaching. Specifically, preferred hand reaches predominated in left hemispace, in spite of the biomechanical inefficiency involved in reaching across the body midline. This was mediated by the skill demands, with a higher frequency of preferred hand reaches for tasks requiring more skill. To further examine this issue, we increased the task skill demands. Twenty-two right-handed adults reached for five tools located in an array of five positions in front of them. Participants were required to pick up the tool, pick up and demonstrate how to use it, or pick up and actually use the tool on the materials provided. The results showed that the frequency of right hand reaches was greatest for the tool use condition. This effect was mediated by the position of the object in hemispace, with more right hand reaches occurring for the Use task in left hemispace than the other tasks, in support of our previous work (Bryden et al., 2003).

Published
2004
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32. Matching-adjusted indirect comparison of bosutinib, dasatinib and nilotinib effect on survival and major cytogenetic response in treatment of second-line chronic phase chronic myeloid leukemia

Author

Cortes, Jorge E., primary, Muresan, Bogdan, additional, Mamolo, Carla, additional, Cappelleri, Joseph C., additional, Crescenzo, Rocco J., additional, Su, Yun, additional, Gambacorti-Passerini, Carlo, additional, Heeg, Bart, additional, and Douglas Smith, B., additional

Published
2019
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35. Impact of Diarrhea on Health-Related Quality of Life: Analysis of the Phase 3 BFORE Trial of Bosutinib Vs Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Author

Brümmendorf, Tim H, primary, Mamolo, Carla M., additional, Reisman, Arlene, additional, Bushmakin, Andrew G, additional, Cappelleri, Joseph C, additional, Crescenzo, Rocco J., additional, DeAnnuntis, Liza, additional, Viquiera, Andrea, additional, and Cortes, Jorge E., additional

Published
2018
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38. Long-term patient-reported outcomes from an open-label safety and efficacy study of bosutinib in Philadelphia chromosome-positive chronic myeloid leukemia patients resistant or intolerant to prior therapy

Author

Kantarjian, Hagop M., primary, Mamolo, Carla M., additional, Gambacorti-Passerini, Carlo, additional, Cortes, Jorge E., additional, Brümmendorf, Tim H., additional, Su, Yun, additional, Reisman, Arlene L., additional, Shapiro, Mark, additional, and Lipton, Jeff H., additional

Published
2017
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39. Additional file 1: of Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial

Author

Papp, Kim, Bissonnette, Robert, Gooderham, Melinda, Feldman, Steven, Iversen, Lars, Soung, Jennifer, Draelos, Zoe, Mamolo, Carla, Purohit, Vivek, Cunshan Wang, and Ports, William

Abstract

Figure S1. Change from baseline in DLQI through Week 16. Table S1. Serious adverse events by treatment group. Table S2. Number and percent of plasma tofacitinib concentration samples (pre-dose and post-dose) by concentration range â available data mild/moderate - post hoc. Table S3. Summary of plasma tofacitinib pharmacokinetic parameters - available data at week 4 - mild/moderate - post hoc. (DOCX 238Â kb)

Published
2016
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42. Tofacitinib improves pruritus and health-related quality of life up to 52 weeks: Results from 2 randomized phase III trials in patients with moderate to severe plaque psoriasis

Author

Feldman, Steven R., primary, Thaçi, Diamant, additional, Gooderham, Melinda, additional, Augustin, Matthias, additional, de la Cruz, Claudia, additional, Mallbris, Lotus, additional, Buonanno, Marjorie, additional, Tatulych, Svitlana, additional, Kaur, Mandeep, additional, Lan, Shuping, additional, Valdez, Hernan, additional, and Mamolo, Carla, additional

Published
2016
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44. Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial

Author

Papp, Kim A., primary, Bissonnette, Robert, additional, Gooderham, Melinda, additional, Feldman, Steven R., additional, Iversen, Lars, additional, Soung, Jennifer, additional, Draelos, Zoe, additional, Mamolo, Carla, additional, Purohit, Vivek, additional, Wang, Cunshan, additional, and Ports, William C., additional

Published
2016
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45. Validation of the Itch Severity Item as a Measurement Tool for Pruritus in Patients with Psoriasis: Results from a Phase 3 Tofacitinib Program.

Author

STÄNDER, Sonja, LUGER, Thomas A., CAPPELLERI, Joseph C., BUSHMAKIN, Andrew G., MAMOLO, Carla, ZIELINSKI, Michael A., TALLMAN, Anna M., and YOSIPOVITCH, Gil

Subjects
ITCHING, SEVERITY of illness index, PSORIASIS, JANUS kinases, PSYCHOMETRICS, PATIENTS, THERAPEUTICS
Abstract

Tofacitinib is an oral Janus kinase inhibitor. This post-hoc analysis aimed to investigate the psychometric properties of the Itch Severity Item (ISI), a numeric rating scale from 0 (no itching) to 10 (worst possible itching) for pruritus in psoriasis, and review the effect of tofacitinib on pruritus in patients with psoriasis participating in Phase 3 studies (N = 3,641). The ISI showed high test-retest reliability (intra-class correlation coefficient: 0.84). The clinically important difference was defined as a 1.48-point change, using Patient Global Assessment as an anchor. Mean changes from baseline in ISI scores with tofacitinib were significantly greater than placebo by Day 2 and exceeded the clinically important difference by Week 4 and Week 2 for tofacitinib 5 and 10 mg twice daily, respectively. The sound psychometric properties of the ISI as an assessment tool for pruritus in psoriasis were confirmed. Tofacitinib provided clinically meaningful improvements in psoriatic pruritus versus placebo. [ABSTRACT FROM AUTHOR]

Published
2018
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