title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).

acronym: COMPASS

summary:
The primary objectives of this study are:

To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

primary_purpose: Prevention

ReferenceCitation: Eikelboom JW, Bosch J, Connolly SJ, Tyrwitt J, Fox KAA, Muehlhofer E, Neumann C, Tasto C, Bangdiwala SI, Diaz R, Alings M, Dagenais GR, Leong DP, Lonn EM, Avezum A, Piegas LS, Widimsky P, Parkhomenko AN, Bhatt DL, Branch KRH, Probstfield JL, Lopez-Jaramillo P, Ryden L, Pogosova N, Keltai K, Keltai M, Ertl G, Stoerk S, Dans AL, Lanas F, Liang Y, Zhu J, Torp-Pedersen C, Maggioni AP, Commerford PJ, Guzik TJ, Vanassche T, Verhamme P, O'Donnell M, Tonkin AM, Varigos JD, Vinereanu D, Felix C, Kim JH, Ibrahim KS, Lewis BS, Metsarinne KP, Aboyans V, Steg PG, Hori M, Kakkar A, Anand SS, Lamy A, Sharma M, Yusuf S. Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):786-795. doi: 10.1093/ehjcvp/pvac023.

ReferenceCitation: Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-6736(17)32409-1. PMID:29132880

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32458-3. doi: 10.1016/S0140-6736(17)32458-3. PMID:29132879

ReferenceCitation: Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.

repository_institution: University College London - UCL Discovery

ReferenceCitation: Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lanius V, Yuan F, Misselwitz F, Chen E, Diaz R, Alings M, Lonn EM, Widimsky P, Hori M, Avezum A, Piegas LS, Bhatt DL, Branch KRH, Probstfield JL, Liang Y, Liu L, Zhu J, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Fox KAA, Kakkar A, Parkhomenko AN, Ertl G, Stork S, Keltai K, Keltai M, Ryden L, Dagenais GR, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Ha JW, Tonkin AM, Varigos JD, Lewis BS, Felix C, Yusoff K, Steg PG, Aboyans V, Metsarinne KP, Anand SS, Hart RG, Lamy A, Moayyedi P, Leong DP, Sharma M, Yusuf S. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial. Can J Cardiol. 2017 Aug;33(8):1027-1035. doi: 10.1016/j.cjca.2017.06.001. Epub 2017 Jun 8.

repository_institution: Monash University - Monash University Research Portal

repository_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: LIRIAS (KU Leuven);Pure (Denmark);eprints.gla.ac.uk;monash.edu;pure.ed.ac.uk;ruj.uj.edu.pl

repositories_institution: Aalborg Universitet - VBN Forskningsportal

repositories_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

repositories_institution: Monash University - Monash University Research Portal

repositories_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Braunwald E. An Important Step for Thrombocardiology. N Engl J Med. 2017 Oct 5;377(14):1387-1388. doi: 10.1056/NEJMe1710241. Epub 2017 Aug 27. No abstract available.

ReferenceCitation: Fauchier L, Bisson A, Angoulvant D. Rivaroxaban in Stable Cardiovascular Disease. N Engl J Med. 2018 Jan 26;378(4):395. doi: 10.1056/NEJMc1714934. No abstract available.

ReferenceCitation: Berger JS. Antithrombotic therapy in peripheral artery disease. Lancet. 2018 Jan 20;391(10117):183-184. doi: 10.1016/S0140-6736(17)32847-7. Epub 2017 Nov 10. No abstract available.

ReferenceCitation: Darmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, Bosch J, Branch KR, Connolly SJ, Dyal L, Eikelboom JW, Fox KAA, Keltai K, Probstfield J, Yusuf S, Abtan J, Sorbets E, Eagle KA, Ducrocq G, Steg PG. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018 Mar 1;39(9):750-757a. doi: 10.1093/eurheartj/ehx658.

ReferenceCitation: Verheugt FWA. Return of Oral Anticoagulation in Chronic Stable Coronary Disease. Circulation. 2018 Apr 17;137(16):1655-1657. doi: 10.1161/CIRCULATIONAHA.117.032916. No abstract available.

ReferenceCitation: Fox KAA, Eikelboom JW, Anand SS, Bhatt DL, Bosch J, Connolly SJ, Harrington RA, Steg PG, Yusuf S. Anti-thrombotic options for secondary prevention in patients with chronic atherosclerotic vascular disease: what does COMPASS add? Eur Heart J. 2019 May 7;40(18):1466-1471. doi: 10.1093/eurheartj/ehy347. No abstract available.

ReferenceCitation: Sharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casanova A, Eikelboom JW, Connolly SJ, Wong G, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KR, Probstfield JL, Kim JH, Ha JW, O'Donnell M, Vinereanu D, Fox KA, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Cook Bruns N, Berkowitz S, Yusuf S. Rationale, design, and baseline participant characteristics in the MRI and cognitive substudy of the cardiovascular outcomes for people using anticoagulation strategies trial. Int J Stroke. 2019 Apr;14(3):270-281. doi: 10.1177/1747493018784478. Epub 2018 Jul 30.

ReferenceCitation: Kruger PC, Eikelboom JW, Yusuf S. Rivaroxaban with or without aspirin for prevention of cardiovascular disease. Coron Artery Dis. 2018 Aug;29(5):361-365. doi: 10.1097/MCA.0000000000000605. No abstract available.

ReferenceCitation: Ademi Z, Zomer E, Tonkin A, Liew D. Cost-effectiveness of rivaroxaban and aspirin compared to aspirin alone in patients with stable cardiovascular disease: An Australian perspective. Int J Cardiol. 2018 Nov 1;270:54-59. doi: 10.1016/j.ijcard.2018.06.091. Epub 2018 Jun 25.

ReferenceCitation: Bhagirath VC, Eikelboom JW, Anand SS. Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Future Cardiol. 2018 Nov;14(6):443-453. doi: 10.2217/fca-2018-0059. Epub 2018 Nov 12.

ReferenceCitation: Kruger PC, Anand SS, de Vries TAC, Eikelboom JW. Patients with Peripheral Artery Disease in the COMPASS Trial. Eur J Vasc Endovasc Surg. 2018 Dec;56(6):772-773. doi: 10.1016/j.ejvs.2018.08.010. Epub 2018 Sep 10. No abstract available.

ReferenceCitation: Boden WE, Bhatt DL. Will COMPASS Point to a New Direction in Thrombotic Risk Reduction in Patients With Stable Cardiovascular Disease? Circulation. 2018 Aug 28;138(9):858-860. doi: 10.1161/CIRCULATIONAHA.118.035405. No abstract available.

ReferenceCitation: Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J, Fox KAA, Zhu J, Lonn E, Dagenais G, Widimsky P, Branch KRH, Bhatt DL, Zheng Z, Straka Z, Dagenais F, Kong Y, Marsden T, Lee SF, Copland I, Yusuf S. Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study. J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048.

ReferenceCitation: Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakovska O, Ng KKH, Catanese L, Keltai K, Aboyans V, Alings M, Ha JW, Varigos J, Tonkin A, O'Donnell M, Bhatt DL, Fox K, Maggioni A, Berkowitz SD, Bruns NC, Yusuf S, Eikelboom JW. Stroke Outcomes in the COMPASS Trial. Circulation. 2019 Feb 26;139(9):1134-1145. doi: 10.1161/CIRCULATIONAHA.118.035864.

ReferenceCitation: Coppens M, Weitz JI, Eikelboom JWA. Synergy of Dual Pathway Inhibition in Chronic Cardiovascular Disease. Circ Res. 2019 Feb;124(3):416-425. doi: 10.1161/CIRCRESAHA.118.313141.

ReferenceCitation: Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Cook Bruns N, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar A, Parkhomenko AN, Ryden L, Pogosova N, Dans A, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik T, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne K, Fox KAA, Yusuf S; COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology. 2019 Aug;157(2):403-412.e5. doi: 10.1053/j.gastro.2019.04.041. Epub 2019 May 2.

ReferenceCitation: Fox KAA, Eikelboom JW, Shestakovska O, Connolly SJ, Metsarinne KP, Yusuf S. Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction: From the COMPASS Trial. J Am Coll Cardiol. 2019 May 14;73(18):2243-2250. doi: 10.1016/j.jacc.2019.02.048.

ReferenceCitation: Cairns JA, Eikelboom JW, Shestakovska O, Yusuf S, DeMets D. Monitoring Emerging Data From the COMPASS Trial of an Antithrombotic Agent. J Am Coll Cardiol. 2019 Jun 4;73(21):2769-2772. doi: 10.1016/j.jacc.2019.03.479. No abstract available.

ReferenceCitation: Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29.

ReferenceCitation: Kruger PC, Guzik TJ, Eikelboom JW. How can the results of the COMPASS trial benefit patients with coronary or peripheral artery disease in Poland? Kardiol Pol. 2019 Aug 23;77(7-8):661-669. doi: 10.33963/KP.14855. Epub 2019 May 30.

repository_institution: Jagiellonian University - Jagiellonian University Repository

repositories_institution: Jagiellonian University - Jagiellonian University Repository

ReferenceCitation: Branch KR, Probstfield JL, Eikelboom JW, Bosch J, Maggioni AP, Cheng RK, Bhatt DL, Avezum A, Fox KAA, Connolly SJ, Shestakovska O, Yusuf S. Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):529-537. doi: 10.1161/CIRCULATIONAHA.119.039609. Epub 2019 Jun 5.

ReferenceCitation: Darmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, Popovic B, Ohman EM, Rother J, Wilson PF, Montalescot G, Zeymer U, Bhatt DL, Steg PG; REACH Registry Investigators. Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients. J Am Coll Cardiol. 2019 Jul 2;73(25):3281-3291. doi: 10.1016/j.jacc.2019.04.046.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Anand SS, Eikelboom JW, Dyal L, Bosch J, Neumann C, Widimsky P, Avezum AA, Probstfield J, Cook Bruns N, Fox KAA, Bhatt DL, Connolly SJ, Yusuf S; COMPASS Trial Investigators. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. J Am Coll Cardiol. 2019 Jul 2;73(25):3271-3280. doi: 10.1016/j.jacc.2019.02.079.

ReferenceCitation: Fox KAA, Metra M, Morais J, Atar D. The myth of 'stable' coronary artery disease. Nat Rev Cardiol. 2020 Jan;17(1):9-21. doi: 10.1038/s41569-019-0233-y. Epub 2019 Jul 29.

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

ReferenceCitation: de Vries TI, Eikelboom JW, Bosch J, Westerink J, Dorresteijn JAN, Alings M, Dyal L, Berkowitz SD, van der Graaf Y, Fox KAA, Visseren FLJ. Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial. Eur Heart J. 2019 Dec 7;40(46):3771-3778a. doi: 10.1093/eurheartj/ehz404.

ReferenceCitation: Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Ryden L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis. Circulation. 2019 Oct 29;140(18):1451-1459. doi: 10.1161/CIRCULATIONAHA.119.041949. Epub 2019 Sep 12.

ReferenceCitation: Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sharma M, Connolly SJ, Yusuf S, Bosch J, Eikelboom JW, Hart RG. Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial. JAMA Neurol. 2020 Jan 1;77(1):43-48. doi: 10.1001/jamaneurol.2019.2984.

ReferenceCitation: Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska O, Dagenais GR, Hart RG, Leong DP, O'Donnell M, Fox KAA, Bhatt DL, Cairns JA, Tasto C, Berkowitz SD, Cook Bruns N, Muehlhofer E, Diaz R, Maggioni AP, Yusuf S. Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin. J Am Coll Cardiol. 2019 Sep 24;74(12):1519-1528. doi: 10.1016/j.jacc.2019.07.065.

ReferenceCitation: Wurtz M, Olesen KKW, Thim T, Kristensen SD, Eikelboom JW, Maeng M. External applicability of the COMPASS trial: the Western Denmark Heart Registry. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):192-199. doi: 10.1093/ehjcvp/pvz013.

ReferenceCitation: Vanassche T, Verhamme P, Anand SS, Shestakovska O, Fox KA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial. Eur J Prev Cardiol. 2020 Feb;27(3):296-307. doi: 10.1177/2047487319882154. Epub 2019 Oct 15.

ReferenceCitation: Cowie MR, Lamy A, Levy P, Mealing S, Millier A, Mernagh P, Cristeau O, Bowrin K, Briere JB. Health economic evaluation of rivaroxaban in the treatment of patients with chronic coronary artery disease or peripheral artery disease. Cardiovasc Res. 2020 Sep 1;116(11):1918-1924. doi: 10.1093/cvr/cvz278.

ReferenceCitation: Welsh RC, Peterson ED, De Caterina R, Bode C, Gersh B, Eikelboom JW. Applying contemporary antithrombotic therapy in the secondary prevention of chronic atherosclerotic cardiovascular disease. Am Heart J. 2019 Dec;218:100-109. doi: 10.1016/j.ahj.2019.09.006. Epub 2019 Oct 23.

ReferenceCitation: Schiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

ReferenceCitation: Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch J, Fox KAA, Steg PG, Vinereanu D, Connolly DL, Berkowitz SD, Foody JM, Probstfield JL, Branch KR, Lewis BS, Diaz R, Muehlhofer E, Widimsky P, Yusuf S, Eikelboom JW, Bhatt DL; COMPASS Investigators. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI). Circulation. 2020 Apr 7;141(14):1141-1151. doi: 10.1161/CIRCULATIONAHA.119.044598. Epub 2020 Mar 17. Erratum In: Circulation. 2020 Jun 9;141(23):e905.

ReferenceCitation: Liang Y, Zhu J, Liu L, Anand SS, Connolly SJ, Bosch J, Guzik TJ, O'Donnell M, Dagenais GR, Fox KA, Shestakovska O, Berkowitz SD, Muehlhofer E, Keller L, Yusuf S, Eikelboom JW; COMPASS Investigators. Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease. Cardiovasc Res. 2021 Feb 22;117(3):942-949. doi: 10.1093/cvr/cvaa100. Erratum In: Cardiovasc Res. 2021 May 25;117(6):1577.

ReferenceCitation: Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anand SS, Verma S, Branch KRH, Probstfield J, Bosch J, Shestakovska O, Szarek M, Maggioni AP, Widimsky P, Avezum A, Diaz R, Lewis BS, Berkowitz SD, Fox KAA, Ryden L, Yusuf S; COMPASS Steering Committee and Investigators. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation. 2020 Jun 9;141(23):1841-1854. doi: 10.1161/CIRCULATIONAHA.120.046448. Epub 2020 Mar 28.

ReferenceCitation: Steffel J, Eikelboom JW, Anand SS, Shestakovska O, Yusuf S, Fox KAA. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48. doi: 10.1161/CIRCULATIONAHA.120.046048. Epub 2020 May 21. Erratum In: Circulation. 2020 Jul 7;142(1):e23.

ReferenceCitation: Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW, Connolly SJ, Dyal L, Reeh KW, Casanova A, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KRH, Probstfield JL, Kim JH, O'Donnell M, Vinereanu D, A A Fox K, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Berkowitz SD, Yusuf S. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy. Stroke. 2020 Oct;51(10):2901-2909. doi: 10.1161/STROKEAHA.120.029762. Epub 2020 Sep 21. Erratum In: Stroke. 2021 Jan;52(2):e90.

ReferenceCitation: Kaplovitch E, Eikelboom JW, Dyal L, Aboyans V, Abola MT, Verhamme P, Avezum A, Fox KAA, Berkowitz SD, Bangdiwala SI, Yusuf S, Anand SS. Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):21-29. doi: 10.1001/jamacardio.2020.4390. Erratum In: JAMA Cardiol. 2021 Feb 1;6(2):246.

ReferenceCitation: Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-Jaramillo P, Dyal L, Berkowitz SD, Muehlhofer E, Bhatt DL, Fox KAA, Yusuf S, Eikelboom JW. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial. J Am Coll Cardiol. 2021 Feb 9;77(5):511-525. doi: 10.1016/j.jacc.2020.11.061.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD, Yusuf S, Verhamme P, Vanassche T, Anand SS, Fox KAA, Eikelboom JW, Amerena J; COMPASS Trial Investigators. Risk stratification of cardiovascular complications using CHA2DS2-VASc and CHADS2 scores in chronic atherosclerotic cardiovascular disease. Int J Cardiol. 2021 Aug 15;337:9-15. doi: 10.1016/j.ijcard.2021.04.067. Epub 2021 May 3.

ReferenceCitation: Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V, Berkowitz SD, Bhatt DL, Connolly SJ, Fox KAA, Muehlhofer E, Probstfield JL, Widimsky P, Winkelmann BR, Yusuf S, Eikelboom JW. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease. Heart. 2021 Jul;107(14):1130-1137. doi: 10.1136/heartjnl-2020-318758. Epub 2021 May 21.

ReferenceCitation: Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686. Erratum In: JAMA Cardiol. 2021 Aug 18;:null.

ReferenceCitation: Vanassche T, Verhamme P, Anand SS, Shestakovska O, Leong DP, Fox KAA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Muehlhofer E, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Low-dose rivaroxaban plus aspirin in patients with polypharmacy and multimorbidity: an analysis from the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):462-473. doi: 10.1093/ehjcvp/pvab050.

ReferenceCitation: Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly SJ, Anand SS, Avezum A, Berkowitz SD, Branch KRH, Dagenais GR, Felix C, Guzik TJ, Hart RG, Maggioni AP, Muehlhofer E, Sharma M, Shestakovska O, Yusuf S. Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol. 2021 Jul 6;78(1):14-23. doi: 10.1016/j.jacc.2021.04.083.

ReferenceCitation: Anand SS, Hiatt W, Dyal L, Bauersachs R, Berkowitz SD, Branch KRH, Debus S, Fox KAA, Liang Y, Muehlhofer E, Nehler M, Haskell LP, Patel M, Szarek M, Yusuf S, Eikelboom J, Bonaca MP. Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials. Eur J Prev Cardiol. 2022 May 5;29(5):e181-e189. doi: 10.1093/eurjpc/zwab128.

ReferenceCitation: Kaplovitch E, Anand SS. The evolving treatment of peripheral arterial disease: preventing ischaemic events in the post-COMPASS era. Cardiovasc Res. 2019 Oct 1;115(12):e121-e124. doi: 10.1093/cvr/cvz170. No abstract available.

ReferenceCitation: Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S. The cost-effectiveness of rivaroxaban with or without aspirin in the COMPASS trial. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):502-510. doi: 10.1093/ehjqcco/qcac054.

ReferenceCitation: Catanese L, Eikelboom JW, Bosch J, Shestakovska O, Ng K, Nayar S, Perera KS, Shoamanesh A, Sharma M, Hart RG. Oral factor Xa inhibitors and risk of subdural hematoma: COMPASS trial results and meta-analysis. Neurology. 2020 Aug 4;95(5):e480-e487. doi: 10.1212/WNL.0000000000009826. Epub 2020 Jul 10.

ReferenceCitation: Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Stork S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10.

ReferenceCitation: Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10. Erratum In: Lancet. 2017 Dec 21;:

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

collaborators:
Population Health Research Institute
Janssen Research & Development, LLC

sponsor_collaborators:
Bayer
Population Health Research Institute
Janssen Research & Development, LLC

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
Malaysia
Philippines
Italy
Ecuador
United Kingdom
Sweden
Netherlands
Korea, Republic of
South Africa
Russian Federation
Israel


type: EudraCT Number

title: A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

summary: The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Robinson JG, Nedergaard BS, Rogers WJ, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014 May 14;311(18):1870-82. doi: 10.1001/jama.2014.4030.

ReferenceCitation: Robinson JG, Rogers WJ, Nedergaard BS, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R. Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2014 Apr;37(4):195-203. doi: 10.1002/clc.22252. Epub 2014 Jan 30.

ReferenceCitation: Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.

ReferenceCitation: Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.

ReferenceCitation: Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.

ReferenceCitation: Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.

ReferenceCitation: Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.

ReferenceCitation: Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.

ReferenceCitation: Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.

ReferenceCitation: Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.

ReferenceCitation: May HT, Muhlestein JB, Ma Y, Lopez JAG, Coll B, Nelson J. Effects of Evolocumab on the ApoA1 Remnant Ratio: A Pooled Analysis of Phase 3 Studies. Cardiol Ther. 2019 Jun;8(1):91-102. doi: 10.1007/s40119-019-0133-6. Epub 2019 Mar 9.

lead_sponsor: Amgen

location_country:
Germany
Australia
Czechia
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Grünenthal GmbH

summary: The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.

ReferenceType: derived

ReferenceCitation: Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

title: Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain

source: euctr

location_country:
Italy
United Kingdom
Denmark
Brazil
Austria
Belgium
Spain
France


title: A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
United States
Spain
Korea, Republic of
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Regional Universitario de Malaga

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: The Pennsylvania State University-Penn State

location_facility: University of Nebraska Medical Center Eppley Cancer Center

location_facility: University of Cincinnati Cancer Institute

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Centre Hospitalier Regional Universitaire Besancon

location_facility: Washington University School of Medicine

location_facility: University of California, San Diego Medical Center

location_facility: Yale University School of Medicine-Yale Cancer Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Sharp Clinical Oncology Research-Sharp Memorial Hospital

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Indiana University Melvin and and Bren Simon Cancer Center

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: H. Lee Moffitt Cancer Center & Research Institute


type: Other Identifier

title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

acronym: RA-BEAM

summary: The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

ReferenceCitation: Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via OAI-PMH title and first author match)

host_type: repository

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;ora.ox.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

ReferenceCitation: van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2022 Feb;49(2):133-141. doi: 10.3899/jrheum.210346. Epub 2021 Sep 15.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum In: Arthritis Res Ther. 2020 Jul 2;22(1):166.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via OAI-PMH doi match)

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Schlueter M, Finn E, Diaz S, Dilla T, Inciarte-Mundo J, Fakhouri W. Cost-effectiveness analysis of baricitinib versus adalimumab for the treatment of moderate-to-severe rheumatoid arthritis in Spain. Clinicoecon Outcomes Res. 2019 Jun 6;11:395-403. doi: 10.2147/CEOR.S201621. eCollection 2019.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Michaud K, Pope JE, Emery P, Zhu B, Gaich CL, DeLozier AM, Zhang X, Dickson CL, Smolen JS. Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial. Rheumatol Ther. 2019 Sep;6(3):409-419. doi: 10.1007/s40744-019-0164-4. Epub 2019 Jun 21.

ReferenceCitation: Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.

ReferenceCitation: Bingham CO 3rd, Gaich CL, DeLozier AM, Engstrom KD, Naegeli AN, de Bono S, Banerjee P, Taylor PC. Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation. Trials. 2019 Mar 22;20(1):182. doi: 10.1186/s13063-019-3272-0. Erratum In: Trials. 2019 Jun 4;20(1):322.

ReferenceCitation: Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

ReferenceCitation: Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum In: J Rheumatol. 2019 Dec;46(12):1648-1649.

ReferenceCitation: Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.

ReferenceCitation: Wells AF, Greenwald M, Bradley JD, Alam J, Arora V, Kartman CE. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21.

ReferenceCitation: Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, Zamora JV, Cobos JAC, Rooney T, Bono S, Arora V, Linetzky B, Weinblatt ME. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017 Nov;76(11):1853-1861. doi: 10.1136/annrheumdis-2017-211259. Epub 2017 Aug 10.

ReferenceCitation: Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Germany
Poland
Argentina
Japan
Croatia
Czechia
Canada
France
Slovenia
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Romania
Belgium
China
Puerto Rico
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: (AOA) Arthritis & Osteoporosis Associates

location_facility: Rheumatology Associates of Central Florida

location_facility: Clinical Research Center of Reading, LLP

location_facility: Center for Arthritis and Rheumatic Diseases, PC

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Asheville Rheumatology & Osteoporosis Research Assoc, PA

location_facility: Carolina Rheumatology and Neurology Associates


title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

status: Terminated

ReferenceCitation: Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

evidence: open (via crossref license)

repositories_concat: PubMed Central

ReferenceCitation: McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.

ReferenceCitation: Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.

publisher_dissemination: Oxford University Press

ReferenceCitation: Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: Yes

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Poland
Portugal
Hungary
Australia
Netherlands
Austria
United States
Spain
Czechia
Canada
France

status_simplified: Unknown


title: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

summary:
The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study.

In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.

After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).

Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data.

The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Dreyling M, Morschhauser F, Bouabdallah K, Bron D, Cunningham D, Assouline SE, Verhoef G, Linton K, Thieblemont C, Vitolo U, Hiemeyer F, Giurescu M, Garcia-Vargas J, Gorbatchevsky I, Liu L, Koechert K, Pena C, Neves M, Childs BH, Zinzani PL. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. doi: 10.1093/annonc/mdx289.

repository_normalized: HAL

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

publisher_dissemination: Elsevier

ReferenceCitation: Panayiotidis P, Follows GA, Mollica L, Nagler A, Ozcan M, Santoro A, Stevens D, Trevarthen D, Hiemeyer F, Garcia-Vargas J, Childs BH, Zinzani PL, Dreyling M. Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma. Blood Adv. 2021 Feb 9;5(3):823-828. doi: 10.1182/bloodadvances.2020002910.

publisher_dissemination: American Society of Hematology

ipd_sharing: No

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Turkey
Canada
France
Portugal
Hungary
Hong Kong
United States
Belgium
Italy
United Kingdom
Singapore
Sweden
Austria
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Israel


lead_sponsor: Hoffmann-La Roche

summary: This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

ReferenceCitation: Lugtenburg P, Avivi I, Berenschot H, Ilhan O, Marolleau JP, Nagler A, Rueda A, Tani M, Turgut M, Osborne S, Smith R, Pfreundschuh M. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017 Nov;102(11):1913-1922. doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Hospital Universitario Dr. Peset; Servicio de Hematologia

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

location_facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

location_facility: Erasmus Mc - Locatie Centrum; Dept of Hematology

location_facility: University Hospital of Ioannina; Hematology

location_facility: Rus Med Academy for Postgraduate Education; Oncology Department

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia

location_facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Hospital de Sao Joao; Servico de Hematologia Clinica

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Tygerberg Hospital; Haematology Department

location_facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division

location_facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Haemek Medical Center; Hematology Department

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

location_facility: Hospital de Donostia; Servicio de Hematologia

location_facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Meander Medisch Centrum; Locatie Lichtenberg

location_facility: Diskapi Research And Training Hospital; hematology

location_facility: Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde

location_facility: City Clinical Hospital #15; Hematology department

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hospital de Cruces; Servicio de Hematologia

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Hematología

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Shaare Zedek Medical Center; Hematology Dept.

location_facility: Georgios Papanikolaou Hospital; Hematology Department

location_facility: Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica

location_facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine

location_facility: Centre ONCOGARD - Institut de Cancerologie du Gard

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: Clinical Center Kragujevac;Center for Hematology

location_facility: Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

location_facility: Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny

location_facility: Military Medical Academy; Hematology And Oncology

location_facility: Southlake Regional Health Center; Community Care Clinic / Oncology

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: Hospital Costa del Sol; Servicio de Hematologia

location_facility: Periph. University General Hospital of Heraklion; Hematology

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: Az. Osp. Sant'Andrea; U.O. C. Ematologia

location_facility: Instituto de Oncologia y Hematologia UCV

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku SUM

location_facility: Hopital Yves Le Foll; Hematologie Oncologie

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

location_facility: Hospital Punta Europa; Servicio de Hematologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Gaziantep Uni Medical School; Hematology

location_facility: Saint-Petersburg SHI City Clinical Hospital #31

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Hematologia

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Hospital de Cabueñes; Servicio de Hematología y Hemoterapia

location_facility: Hospital Lucus Augusti; Servicio de Hematologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo

location_facility: Theagenio Anticancer Hospital; Dept. of Haematology

location_facility: Maxima Medisch Centrum; Inwendige Geneeskunde

location_facility: University Hospital Sv.Georgi Clnic of Hematology; Hematology

location_facility: Hia Sainte Anne; Medecine Interne Oncologie

location_facility: St James' Hospital; Cancer Clinical Trials Office

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Swietokrzyskie Centrum Onkologii; Onkologia Ogolna

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Ospedale Di Circolo E Fondazione Macchi; Ematologia

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Regional health authority A vitalite health network

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

location_facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: University General Hospital of Alexandroupolis; Haemotology

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

location_facility: Hopital Hautepierre; Hematologie Oncologie

title: A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

location_country:
Finland
Ireland
Poland
Argentina
Algeria
Brazil
Thailand
Turkey
Canada
Serbia
France
Colombia
Portugal
Ukraine
Belgium
Peru
Italy
United Kingdom
Venezuela
Netherlands
Saudi Arabia
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel


title: A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

summary: The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

oa_colors: green other

evidence: oa repository (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Diabetes Association

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
Germany
Italy
Lithuania
Guatemala
Poland
New Zealand
Australia
Mexico
United States
Latvia
Spain
Georgia
South Africa
Ukraine
Canada
Estonia
Russian Federation
France

location_facility: 1276.10.11017 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37203 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37201 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11048 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50201 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11026 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.61002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11011 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11035 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11028 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37102 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11036 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99506 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11022 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11040 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37101 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11055 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11029 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11043 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11013 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.64001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99505 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11042 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50203 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11034 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11010 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11030 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99504 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11016 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11031 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11050 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20010 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11049 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11044 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11058 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11018 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99502 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50202 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99503 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50204 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11051 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33014 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11047 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99501 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11024 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37202 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37204 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.64002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11015 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11020 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.52004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11012 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11041 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50205 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.61001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11033 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70009 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.27005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37104 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33011 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37103 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11027 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33006 Boehringer Ingelheim Investigational Site


title: A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

summary: This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Australia
Brazil
Japan
Canada
France
Czech Republic
Hungary
Hong Kong
United States
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: Washington University School of Medicine Regulatory

location_facility: Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA

location_facility: California Cancer Care Marian Speciality

location_facility: Northwest Georgia Oncology Center NW Georgia Onc

location_facility: Northwest Cancer Specialists Vancouver Loc

location_facility: University of Texas Southwestern Medical Center Harry Hines

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: University of Oklahoma Health Sciences Center OUHSC 2

location_facility: Arizona Oncology Associates Dept of Oncology

location_facility: H. Lee Moffitt Cancer Center & Research Institute SC

location_facility: University of New Mexico Cancer Research Center Dept of Univ New Mexico

location_facility: Rocky Mountain Cancer Centers RMCC Hale Pkwy

location_facility: University of Kansas Cancer Center Univ Kansas 2

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp


title: A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.

summary: Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Garcia-Manero G, Almeida A, Giagounidis A, Platzbecker U, Garcia R, Voso MT, Larsen SR, Valcarcel D, Silverman LR, Skikne B, Santini V. Design and rationale of the QUAZAR Lower-Risk MDS (AZA-MDS-003) trial: a randomized phase 3 study of CC-486 (oral azacitidine) plus best supportive care vs placebo plus best supportive care in patients with IPSS lower-risk myelodysplastic syndromes and poor prognosis due to red blood cell transfusion-dependent anemia and thrombocytopenia. BMC Hematol. 2016 May 3;16:12. doi: 10.1186/s12878-016-0049-5. eCollection 2016.

ReferenceCitation: Garcia-Manero G, Santini V, Almeida A, Platzbecker U, Jonasova A, Silverman LR, Falantes J, Reda G, Buccisano F, Fenaux P, Buckstein R, Diez Campelo M, Larsen S, Valcarcel D, Vyas P, Giai V, Oliva EN, Shortt J, Niederwieser D, Mittelman M, Fianchi L, La Torre I, Zhong J, Laille E, Lopes de Menezes D, Skikne B, Beach CL, Giagounidis A. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes. J Clin Oncol. 2021 May 1;39(13):1426-1436. doi: 10.1200/JCO.20.02619. Epub 2021 Mar 25.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Tor Vergata University - Cineca Institutional Research Information System

repository_institution: University of Florence - Florence Research

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;art.torvergata.it;flore.unifi.it;ora.ox.ac.uk;www.repositoriosalud.es

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Celgene

location_country:
Finland
Germany
Poland
Australia
Brazil
Turkey
Czechia
Canada
France
Portugal
Denmark
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Israel

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: VA Commonwealth University - Massey Cancer Center

location_facility: Weill Cornell Medical College - New York - Presbyterian Hospital

location_facility: University Hospitals of Cleveland Case Medical Center

location_facility: Icahn School of Medicine at Mount Sinai Medical Center

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: University of Southern California Norris Cancer Center

location_facility: Hematology And Oncology Specialists, Llc

location_facility: Phoebe Cancer Center of Phoebe Putney Memorial Hospital

location_facility: University of Louisville, J.G. Brown Cancer Center

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: Robert H Lurie Comprehensive Cancer Center NW Univ

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Tower Hematology/Oncology Medical Group and Tower Cancer Research Found

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

status_simplified: Ongoing


title: AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

summary: This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

ReferenceCitation: Stelljes M, Advani AS, DeAngelo DJ, Wang T, Neuhof A, Vandendries E, Kantarjian H, Jabbour E. Time to First Subsequent Salvage Therapy in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin in the Phase III INO-VATE Trial. Clin Lymphoma Myeloma Leuk. 2022 Sep;22(9):e836-e843. doi: 10.1016/j.clml.2022.04.022. Epub 2022 Apr 27.

ReferenceCitation: Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

ReferenceCitation: Kantarjian HM, Stock W, Cassaday RD, DeAngelo DJ, Jabbour E, O'Brien SM, Stelljes M, Wang T, Paccagnella ML, Nguyen K, Sleight B, Vandendries E, Neuhof A, Laird AD, Advani AS. Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy, and Safety by Baseline CD22. Clin Cancer Res. 2021 May 15;27(10):2742-2754. doi: 10.1158/1078-0432.CCR-20-2399. Epub 2021 Feb 18.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Stock W, Martinelli G, Stelljes M, DeAngelo DJ, Gokbuget N, Advani AS, O'Brien S, Liedtke M, Merchant AA, Cassaday RD, Wang T, Zhang H, Vandendries E, Jabbour E, Marks DI, Kantarjian HM. Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia. Cancer. 2021 Mar 15;127(6):905-913. doi: 10.1002/cncr.33321. Epub 2020 Nov 24.

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: Wiley

ReferenceCitation: DeAngelo DJ, Advani AS, Marks DI, Stelljes M, Liedtke M, Stock W, Gokbuget N, Jabbour E, Merchant A, Wang T, Vandendries E, Neuhof A, Kantarjian H, O'Brien S. Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden. Blood Cancer J. 2020 Aug 7;10(8):81. doi: 10.1038/s41408-020-00345-8.

ReferenceCitation: Jabbour E, Gokbuget N, Advani A, Stelljes M, Stock W, Liedtke M, Martinelli G, O'Brien S, Wang T, Laird AD, Vandendries E, Neuhof A, Nguyen K, Dakappagari N, DeAngelo DJ, Kantarjian H. Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial. Leuk Res. 2020 Jan;88:106283. doi: 10.1016/j.leukres.2019.106283. Epub 2019 Nov 25.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Fujishima N, Uchida T, Onishi Y, Jung CW, Goh YT, Ando K, Wang MC, Ono C, Matsumizu M, Paccagnella ML, Sleight B, Vandendries E, Fujii Y, Hino M. Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Int J Hematol. 2019 Dec;110(6):709-722. doi: 10.1007/s12185-019-02749-0. Epub 2019 Nov 13.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gokbuget N, O'Brien SM, Jabbour E, Wang T, Liang White J, Sleight B, Vandendries E, Advani AS. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019 Jul 15;125(14):2474-2487. doi: 10.1002/cncr.32116. Epub 2019 Mar 28.

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Jabbour EJ, DeAngelo DJ, Stelljes M, Stock W, Liedtke M, Gokbuget N, O'Brien S, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS, Kantarjian HM. Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Cancer. 2018 Apr 15;124(8):1722-1732. doi: 10.1002/cncr.31249. Epub 2018 Jan 30.

ReferenceCitation: Kebriaei P, Cutler C, de Lima M, Giralt S, Lee SJ, Marks D, Merchant A, Stock W, van Besien K, Stelljes M. Management of important adverse events associated with inotuzumab ozogamicin: expert panel review. Bone Marrow Transplant. 2018 Apr;53(4):449-456. doi: 10.1038/s41409-017-0019-y. Epub 2018 Jan 12.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Advani AS, Stelljes M, Kebriaei P, Cassaday RD, Merchant AA, Fujishima N, Uchida T, Calbacho M, Ejduk AA, O'Brien SM, Jabbour EJ, Zhang H, Sleight BJ, Vandendries ER, Marks DI. Hepatic adverse event profile of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukaemia: results from the open-label, randomised, phase 3 INO-VATE study. Lancet Haematol. 2017 Aug;4(8):e387-e398. doi: 10.1016/S2352-3026(17)30103-5. Epub 2017 Jul 4.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gokbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Finland
Germany
Poland
Argentina
Australia
Japan
Czechia
Canada
France
Hungary
United States
China
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: Nottingham University Hospitals NHS Trust

location_facility: New York Presbyterian Hospital-Weill Cornell Medical College

location_facility: Zentralapotheke des Universitaetsklinikums Muenster

location_facility: University of Colorado Hospital, Cancer Center Infusion Center

location_facility: IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center

location_facility: CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique

location_facility: West Virginia University Hospitals Pharmaceutical Services

location_facility: Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital

location_facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center

location_facility: U.O. Ematologia, Ospedale S. Maria delle Croci

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Investigational Drug Service, Emory University Clinic

location_facility: Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center

location_facility: Stanford University Hospital and Clinics

location_facility: UCLA Drug Information/Investigation Drug

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Yale-New Haven Hospital & Smilow Cancer Center

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika

location_facility: Martha Hamilton, Investigational Drug Services, Dept of Pharmacy

location_facility: C.H.U. de Grenoble, Hopital Albert Michallon

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Eastern Clinical Research Unit, Box Hill Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,

location_facility: A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto

location_facility: University of Chicago Medical Center, Dept. of Pharmacy

location_facility: Interni Hematologicka a Onkologicka Klinika

location_facility: UT Southwestern University Hospital- Zale Lipshy

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: Freidenrich Center for Translational Research (CTRU), Stanford University

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Penn State Milton S. Hershey Medical Center,

location_facility: Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)

location_facility: National University Hospital/National University Cancer Institute Singapore (NCIS)

location_facility: MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy

location_facility: Investigational Drug Services - UC San Diego Moores Cancer Center

location_facility: University of Texas Southwestern Universtiy Hospital - William P Clements Jr.

location_facility: Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles

location_facility: Chang Gung Medical Foundation, Kaohsiung Branch

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Hospital General Universitario Jose Maria Morales Meseguer

location_facility: Stony Brook University Medical Center, The Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliera Brotzu CTMO P.O. Businco

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Northwestern Medicine Developmental Therapeutics Institute

location_facility: Division of Hematology/Oncology, Stony Brook University Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: UNC Hospitals - The University of North Carolina at Chapel Hill

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;

location_facility: Winship Cancer Institute, Emory University

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Universitätsklinikum Köln, Klinik I für Innere Medizin

location_facility: Chonnam National University, Hwasun Hospital


title: POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)

acronym: PASCO II

summary: The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Pfizer

collaborators: Hospira, now a wholly owned subsidiary of Pfizer

location_country:
Finland
Germany
Ireland
Italy
United Kingdom
Denmark
Sweden
Spain
Greece
Croatia
Bulgaria
France

location_facility: Njurmedicinska kliniken, Danderyds sjukhus

location_facility: Märkische Kliniken GmbH Klinikum Lüdenscheid

location_facility: Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)

location_facility: Dipartimento di Nefrologia- Ospedale Mazzoni

location_facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi

location_facility: General Hospital of Komotini Sismanogleio

location_facility: Dutchmed Dialysis Clinic (in the building of 5 DCC)

location_facility: Hopital de Rangueil, service de nephrologie

location_facility: U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese

location_facility: Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,

location_facility: Deutsche Klinik fuer Diagnostik Department of Nephrology

location_facility: Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala

location_facility: U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"

location_facility: ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI

location_facility: Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi

location_facility: Office of Eleni Stefanopoulou/Private Physician

location_facility: Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi

location_facility: Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital

location_facility: Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale

location_facility: U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli

location_facility: Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi

location_facility: "Presidio Ospedaliero" di Soverato - Servizio Dialisi

location_facility: U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Gemeinschaftspraxis Schuerfeld Moeller Henrich

location_facility: CHU Amiens-Picardie Site Sud,, service de Nefrologie

location_facility: Nephrologisches- und Dialysezentrum Niebüll

location_facility: Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG

location_facility: 35 Nephrologie Centre Medico Chirurgical de l'Europe

location_facility: Presidio ospesdaliero G.CRISCUOLI - UO DIALISI

location_facility: Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH

location_facility: U.O.C. Nefrologia e Dialisi Azienda Ospedaliera

location_facility: Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin

location_facility: Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo

location_facility: Gemeinschaftspraxis Dr. Gööck & Dr. Anger

location_facility: Hospital Gabriel Montpied, Centre de Dialyse

location_facility: Dipartimento di Medicina -DIMED- Policlinico Padova

location_facility: Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"

location_facility: Ospedale Martini - S.C. Nefrologia E Dialisi

location_facility: Hospital Universitario Central de Asturias

location_facility: Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI

location_facility: A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto

location_facility: Nephrologische Gemeinschaftspraxis und Dialysezentrum

location_facility: Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica

location_facility: UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa

location_facility: Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH

location_facility: Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge

location_facility: ze:ro Dialysezentren und Gemeinschaftspraxis

location_facility: OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi

location_facility: A.O. MONALDI- Dept nephrology and Dialysis

location_facility: University General Hospital of Alexandroupoli