351 results on '"Hasford, J."'
Search Results
2. Treatment and outcome of 2904 CML patients from the EUTOS population-based registry
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Hoffmann, V S, Baccarani, M, Hasford, J, Castagnetti, F, Di Raimondo, F, Casado, L F, Turkina, A, Zackova, D, Ossenkoppele, G, Zaritskey, A, Höglund, M, Simonsson, B, Indrak, K, Sninska, Z, Sacha, T, Clark, R, Bogdanovic, A, Hellmann, A, Griskevicius, L, Schubert-Fritschle, G, Sertic, D, Guilhot, J, Lejniece, S, Zupan, I, Burgstaller, S, Koskenvesa, P, Everaus, H, Costeas, P, Lindoerfer, D, Rosti, G, Saussele, S, Hochhaus, A, and Hehlmann, R
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- 2017
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3. Prognosis of long-term survival considering disease-specific death in patients with chronic myeloid leukemia
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Pfirrmann, M, Baccarani, M, Saussele, S, Guilhot, J, Cervantes, F, Ossenkoppele, G, Hoffmann, V S, Castagnetti, F, Hasford, J, Hehlmann, R, and Simonsson, B
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- 2016
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4. In-hospital fall-risk screening in 4,735 geriatric patients from the LUCAS project
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Neumann, L., Hoffmann, V.S., Golgert, S., Hasford, J., and von Renteln-Kruse, Wolfgang
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- 2013
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5. Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants
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Hehlmann, R, Lauseker, M, Saußele, S, Pfirrmann, M, Krause, S, Kolb, H J, Neubauer, A, Hossfeld, D K, Nerl, C, Gratwohl, A, Baerlocher, G M, Heim, D, Brümmendorf, T H, Fabarius, A, Haferlach, C, Schlegelberger, B, Müller, M C, Jeromin, S, Proetel, U, Kohlbrenner, K, Voskanyan, A, Rinaldetti, S, Seifarth, W, Spieß, B, Balleisen, L, Goebeler, M C, Hänel, M, Ho, A, Dengler, J, Falge, C, Kanz, L, Kremers, S, Burchert, A, Kneba, M, Stegelmann, F, Köhne, C A, Lindemann, H W, Waller, C F, Pfreundschuh, M, Spiekermann, K, Berdel, W E, Müller, L, Edinger, M, Mayer, J, Beelen, D W, Bentz, M, Link, H, Hertenstein, B, Fuchs, R, Wernli, M, Schlegel, F, Schlag, R, de Wit, M, Trümper, L, Hebart, H, Hahn, M, Thomalla, J, Scheid, C, Schafhausen, P, Verbeek, W, Eckart, M J, Gassmann, W, Pezzutto, A, Schenk, M, Brossart, P, Geer, T, Bildat, S, Schäfer, E, Hochhaus, A, and Hasford, J
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- 2017
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6. The EUTOS population-based registry: incidence and clinical characteristics of 2904 CML patients in 20 European Countries
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Hoffmann, V S, Baccarani, M, Hasford, J, Lindoerfer, D, Burgstaller, S, Sertic, D, Costeas, P, Mayer, J, Indrak, K, Everaus, H, Koskenvesa, P, Guilhot, J, Schubert-Fritschle, G, Castagnetti, F, Di Raimondo, F, Lejniece, S, Griskevicius, L, Thielen, N, Sacha, T, Hellmann, A, Turkina, A G, Zaritskey, A, Bogdanovic, A, Sninska, Z, Zupan, I, Steegmann, J-L, Simonsson, B, Clark, R E, Covelli, A, Guidi, G, and Hehlmann, R
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- 2015
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7. Safety and efficacy of imatinib in CML over a period of 10 years: data from the randomized CML-study IV
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Kalmanti, L, Saussele, S, Lauseker, M, Müller, M C, Dietz, C T, Heinrich, L, Hanfstein, B, Proetel, U, Fabarius, A, Krause, S W, Rinaldetti, S, Dengler, J, Falge, C, Oppliger-Leibundgut, E, Burchert, A, Neubauer, A, Kanz, L, Stegelmann, F, Pfreundschuh, M, Spiekermann, K, Scheid, C, Pfirrmann, M, Hochhaus, A, Hasford, J, and Hehlmann, R
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- 2015
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8. Velocity of early BCR-ABL transcript elimination as an optimized predictor of outcome in chronic myeloid leukemia (CML) patients in chronic phase on treatment with imatinib
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Hanfstein, B, Shlyakhto, V, Lauseker, M, Hehlmann, R, Saussele, S, Dietz, C, Erben, P, Fabarius, A, Proetel, U, Schnittger, S, Krause, S W, Schubert, J, Einsele, H, Hänel, M, Dengler, J, Falge, C, Kanz, L, Neubauer, A, Kneba, M, Stegelmann, F, Pfreundschuh, M, Waller, C F, Spiekermann, K, Baerlocher, G M, Pfirrmann, M, Hasford, J, Hofmann, W-K, Hochhaus, A, and Müller, M C
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- 2014
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9. Secondary malignancies in chronic myeloid leukemia patients after imatinib-based treatment: long-term observation in CML Study IV
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Miranda, M B, Lauseker, M, Kraus, M-P, Proetel, U, Hanfstein, B, Fabarius, A, Baerlocher, G M, Heim, D, Hossfeld, D K, Kolb, H-J, Krause, S W, Nerl, C, Brümmendorf, T H, Verbeek, W, Fauser, A A, Prümmer, O, Neben, K, Hess, U, Mahlberg, R, Plöger, C, Flasshove, M, Rendenbach, B, Hofmann, W-K, Müller, M C, Pfirrmann, M, Hochhaus, A, Hasford, J, Hehlmann, R, and Sauele, S
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- 2016
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10. Long-term outcome of patients with newly diagnosed chronic myeloid leukemia: a randomized comparison of stem cell transplantation with drug treatment
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Gratwohl, A, Pfirrmann, M, Zander, A, Kröger, N, Beelen, D, Novotny, J, Nerl, C, Scheid, C, Spiekermann, K, Mayer, J, Sayer, H G, Falge, C, Bunjes, D, Döhner, H, Ganser, A, Schmidt-Wolf, I, Schwerdtfeger, R, Baurmann, H, Kuse, R, Schmitz, N, Wehmeier, A, Th Fischer, J, Ho, A D, Wilhelm, M, Goebeler, M-E, Lindemann, H W, Bormann, M, Hertenstein, B, Schlimok, G, Baerlocher, G M, Aul, C, Pfreundschuh, M, Fabian, M, Staib, P, Edinger, M, Schatz, M, Fauser, A, Arnold, R, Kindler, T, Wulf, G, Rosselet, A, Hellmann, A, Schäfer, E, Prümmer, O, Schenk, M, Hasford, J, Heimpel, H, Hossfeld, D K, Kolb, H-J, Büsche, G, Haferlach, C, Schnittger, S, Müller, M C, Reiter, A, Berger, U, Sauele, S, Hochhaus, A, and Hehlmann, R
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- 2016
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11. Survival, prognostic factors and rates of leukemic transformation in 381 untreated patients with MDS and del(5q): A multicenter study
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Germing, U, Lauseker, M, Hildebrandt, B, Symeonidis, A, Cermak, J, Fenaux, P, Kelaidi, C, Pfeilstöcker, M, Nösslinger, T, Sekeres, M, Maciejewski, J, Haase, D, Schanz, J, Seymour, J, Kenealy, M, Weide, R, Lübbert, M, Platzbecker, U, Valent, P, Götze, K, Stauder, R, Blum, S, Kreuzer, K-A, Schlenk, R, Ganser, A, Hofmann, W-K, Aul, C, Krieger, O, Kündgen, A, Haas, R, Hasford, J, and Giagounidis, A
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- 2012
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12. Recommendations to meet statistical challenges arising from endpoints beyond overall survival in clinical trials on chronic myeloid leukemia
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Pfirrmann, M, Hochhaus, A, Lauseker, M, Saußele, S, Hehlmann, R, and Hasford, J
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- 2011
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13. Arzneimittelprüfung an nicht einwilligungsfähigen Erwachsenen: Kritische Bewertung der neuen gesetzlichen Regelung durch medizinische Ethikkommissionen in Deutschland [Critical evaluation of the new legal regulation of pharmaceutical trials with adults who lack decision-making capacity: a survey of human research ethics committees in Germany]
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Götz, S.C., Marckmann, G., Hasford, J., and Jox, R.J.
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Adult ,Clinical Trials as Topic ,Decision Making ,Ethics Committees ,Ethics Committees, Research ,Germany ,Humans ,Informed Consent ,Surveys and Questionnaires ,Decision-making capacity ,Law on pharmaceutical products ,Research ethics ,Research ethics committees ,Research with indirect benefit ,humanities - Abstract
In Germany, the drug law was revised in 2016 to include new regulations on clinical drug trials with adults who lack decision-making capacity. For the first time, trials with a merely indirect benefit (benefit for other patients with similar characteristics) will be possible if several safeguards are respected. The ethical justification and practicality of this regulation are controversially discussed. (1) Eliciting the current pertinent practice of research ethics committees in Germany regarding research with indirect benefit on adults without decision-making capacity; (2) exploring the possibilities and difficulties of implementing the new law. Semiquantitative, anonymous questionnaire among 249 members of all 53 human research ethics committees in Germany. Eighty-four questionnaires were analyzed (response rate 34%). The participants disagreed on assigning research projects to the categories of research with direct benefit to the subject, with an indirect benefit, and without any benefit. Moreover, the criteria of minimum risk and minimum burden were interpreted heterogeneously. More than half of the participants judged the newly introduced research advance directive to be unnecessary, given the legal safeguards in place. The applicability of these directives was doubted because of the strict requirements for anticipatory informed consent and the restricted predictability of future research. In spite of the new legal regulation, significant ethical uncertainties remain concerning research with indirect benefit on adults without decision-making capacity. It remains an open question whether we need a better explanation of the law, additional legal regulation, practice evaluation, or a completely new law.
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- 2020
14. Cytogenetic response to prior treatment with interferon-α is predictive for survival after allogeneic hematopoietic stem cell transplantation in chronic myeloid leukemia
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Maywald, O, Pfirrmann, M, Berger, U, Breitscheidel, L, Gratwohl, A, Kolb, H-J, Beelen, D W, Tobler, A, Metzgeroth, G, Gnad, S U, Hochhaus, A, Hasford, J, Hehlmann, R, and Reiter, A
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- 2006
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15. Gender aspects in chronic myeloid leukemia: long-term results from randomized studies
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Berger, U, Maywald, O, Pfirrmann, M, Lahaye, T, Hochhaus, A, Reiter, A, Hasford, J, Heimpel, H, Hossfeld, D K, Kolb, H-J, Löffler, H, Pralle, H, Queisser, W, and Hehlmann, R
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- 2005
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16. Treatment intensity significantly influencing fibrosis in bone marrow independently of the cytogenetic response: meta-analysis of the long-term results from two prospective controlled trials on chronic myeloid leukemia
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Buesche, G, Freund, M, Hehlmann, R, Georgii, A, Ganser, A, Hecker, H, Heimpel, H, Fonatsch, C, Heinze, B, Pfirrmann, M, Holgado, S, Schmeil, A, Tobler, A, Hasford, J, Buhr, T, and Kreipe, H-H
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- 2004
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17. The German competence network ‘Acute and chronic leukemias’
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Hehlmann, R, Berger, U, Aul, C, Büchner, Th, Döhner, H, Ehninger, G, Ganser, A, Gökbuget, N, Hoelzer, D, Überla, K, Gassmann, W, Ludwig, W D, Rieder, H, Kneba, M, Hochhaus, A, Reiter, A, Hiddemann, W, Ottmann, O G, Germing, U, Adelhard, K, Dugas, M, Dirschedl, P, Messerer, D, Böhme, A, Harrison-Neu, E, Griesshammer, M, Kienast, J, Kolb, H J, Ho, A D, Hallek, M, Neubauer, A, Schlegelberger, B, Niederwieser, D, Heil, G, Müller, T, and Hasford, J
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- 2004
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18. Marrow fibrosis, indicator of therapy failure in chronic myeloid leukemia – prospective long-term results from a randomized-controlled trial
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Buesche, G, Hehlmann, R, Hecker, H, Heimpel, H, Heinze, B, Schmeil, A, Pfirrmann, M, Gomez, G, Tobler, A, Herrmann, H, Kappler, M, Hasford, J, Buhr, T, Kreipe, H-H, and Georgii, A
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- 2003
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19. Chronic myeloid leukemia in the elderly: long-term results from randomized trials with interferon α
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Berger, U, Engelich, G, Maywald, O, Pfirrmann, M, Hochhaus, A, Reiter, A, Metzgeroth, G, Gnad, U, Hasford, J, Heinze, B, Heimpel, H, Hossfeld, D K, Kolb, H-J, Löffler, H, Pralle, H, Queisser, W, and Hehlmann, R
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- 2003
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20. Randomized comparison of interferon α and hydroxyurea with hydroxyurea monotherapy in chronic myeloid leukemia (CML-study II): prolongation of survival by the combination of interferon α and hydroxyurea
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Hehlmann, R, Berger, U, Pfirrmann, M, Hochhaus, A, Metzgeroth, G, Maywald, O, Hasford, J, Reiter, A, Hossfeld, D K, Kolb, H-J, Löffler, H, Pralle, H, Queißer, W, Griesshammer, M, Nerl, C, Kuse, R, Tobler, A, Eimermacher, H, Tichelli, A, Aul, C, Wilhelm, M, Fischer, J T, Perker, M, Scheid, C, Schenk, M, Weiß, J, Meier, C R, Kremers, S, Labedzki, L, Schmeiser, T, Lohrmann, H-P, and Heimpel, H
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- 2003
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21. German Multicenter Study Group for Adult ALL (GMALL): recruitment in comparison to ALL incidence and its impact on study results
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Dugas, M., Messerer, D., Hasford, J., Haferlach, T., Heinze, B., Ludwig, W., Rieder, H., Schoch, R., Schwartz, S., and Thiel, E.
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- 2003
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22. Lenalidomide does not increase AML progression risk in RBC transfusion-dependent patients with Low- or Intermediate-1-risk MDS with del(5q): a comparative analysis
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Kuendgen, A, Lauseker, M, List, AF, Fenaux, P, Giagounidis, AA, Brandenburg, NA, Backstrom, J, Glasmacher, A, Hasford, J, and Germing, U
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- 2013
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23. A population-based European cohort study of persistence in newly diagnosed hypertensive patients
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Hasford, J, Mimran, A, and Simons, W R
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- 2002
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24. Early molecular and cytogenetic response is predictive for long-term progression-free and overall survival in chronic myeloid leukemia (CML)
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Hanfstein, B, Müller, M C, Hehlmann, R, Erben, P, Lauseker, M, Fabarius, A, Schnittger, S, Haferlach, C, Göhring, G, Proetel, U, Kolb, H-J, Krause, S W, Hofmann, W-K, Schubert, J, Einsele, H, Dengler, J, Hänel, M, Falge, C, Kanz, L, Neubauer, A, Kneba, M, Stegelmann, F, Pfreundschuh, M, Waller, C F, Branford, S, Hughes, T P, Spiekermann, K, Baerlocher, G M, Pfirrmann, M, Hasford, J, Sauele, S, and Hochhaus, A
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- 2012
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25. Clinical trials underestimate the age of chronic myeloid leukemia (CML) patients. Incidence and median age of Ph/BCR-ABL-positive CML and other chronic myeloproliferative disorders in a representative area in Germany
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Rohrbacher, M, Berger, U, Hochhaus, A, Metzgeroth, G, Adam, K, Lahaye, T, Saussele, S, Müller, M C, Hasford, J, Heimpel, H, and Hehlmann, R
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- 2009
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26. PREVENTABILITY OF ADVERSE DRUG REACTIONS LEADING TO HOSPITAL ADMISSION — ASSESSMENT OF INTER-RATER VARIABILITY WITHIN THE NETWORK OF REGIONAL PHARMACOVIGILANCE CENTERS: 5
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Schmiedl, S., Szymanski, J., Rottenkolber, M., Drewelow, B., Siegmund, W., Hippius, M., Farker, K., Hasford, J., and Thürmann, P. A.
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- 2009
27. PATIENT SELF-MEDICATION AND SERIOUS ADVERSE DRUG REACTIONS (ADRS): 3
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Farker, K., Rottenkolber, M., Drewelow, B., Hippius, M., Siegmund, W., Thürmann, P., and Hasford, J.
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- 2009
28. MODULATORS FOR ELECTRONIC RISK PREDICTION OF ADVERSE DRUG EVENTS - PATIENT CHARACTERISTICS IN DRUG-DRUG INTERACTIONS AND DOSE ADJUSTMENTS: 80
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Senger, C., Seidling, H. M., W. Schmitt, S. P., Bertsche, T., Szymanski, J., Schmiedl, S., Rottenkolber, M., Kaltschmidt, J., Drewelow, B., Siegmund, W., Hippius, M., Farker, K., Hasford, J., Thürmann, P. A., and Haefeli, W. E.
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- 2009
29. A THRESHOLD VALUE TO INCREASE THE CLINICAL RELEVANCE OF OVERDOSE ALERTS: 79
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Seidling, H. M., Senger, C., Szymanski, J., Bertsche, T., Kaltschmidt, J., Schmiedl, S., Thürmann, P. A., Farker, K., Drewelow, B., Hippius, M., Siegmund, W., Hasford, J., and Haefeli, W. E.
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- 2009
30. Oral insulin therapy for primary prevention of type 1 diabetes in infants with high genetic risk: the GPPAD-POInT (global platform for the prevention of autoimmune diabetes primary oral insulin trial) study protocol
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Ziegler, A, Achenbach, P, Berner, R, Casteels, K, Danne, T, Gündert, M, Hasford, J, Hoffmann, V, Kordonouri, O, Lange, K, Elding Larsson, H, Lundgren, M, Snape, M, Szypowska, A, Todd, J, Bonifacio, E, and Group, Gppad Study
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Administration, Oral ,030209 endocrinology & metabolism ,Placebo ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Diabetes mellitus ,Internal medicine ,Clinical Trials ,General Diabetes ,Paediatric Endocrinology ,Outcome Assessment, Health Care ,medicine ,Protocol ,Humans ,Hypoglycemic Agents ,Insulin ,Genetic Predisposition to Disease ,Family history ,030304 developmental biology ,Autoantibodies ,Randomized Controlled Trials as Topic ,0303 health sciences ,Type 1 diabetes ,clinical trials ,business.industry ,Incidence (epidemiology) ,general diabetes ,Autoantibody ,Infant ,General Medicine ,medicine.disease ,3. Good health ,ddc ,Clinical trial ,Europe ,Primary Prevention ,Diabetes and Endocrinology ,Diabetes Mellitus, Type 1 ,Female ,business ,paediatric endocrinology - Abstract
IntroductionThe POInT study, an investigator initiated, randomised, placebo-controlled, double-blind, multicentre primary prevention trial is conducted to determine whether daily administration of oral insulin, from age 4.0 months to 7.0 months until age 36.0 months to children with elevated genetic risk for type 1 diabetes, reduces the incidence of beta-cell autoantibodies and diabetes.Methods and analysisInfants aged 4.0 to 7.0 months from Germany, Poland, Belgium, UK and Sweden are eligible if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies as determined by genetic risk score or family history and human leucocyte antigen genotype. Infants are randomised 1:1 to daily oral insulin (7.5 mg for 2 months, 22.5 mg for 2 months, 67.5 mg until age 36.0 months) or placebo, and followed for a maximum of 7 years. Treatment and follow-up is stopped if a child develops diabetes. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies or diabetes. Other outcomes are: (1) Any persistent confirmed beta-cell autoantibody (glutamic acid decarboxylase (GADA), IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4) Abnormal glucose tolerance or diabetes.Ethics and disseminationThe study is approved by the ethical committees of all participating clinical sites. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the trial.Trial registration numberNCT03364868.
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- 2019
31. How long will chronic myeloid leukemia patients treated with imatinib mesylate live?
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Hasford, J, Pfirrmann, M, and Hochhaus, A
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- 2005
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32. Abstract
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Mache, Ch., Urban, Ch., Sauer, H., Brandesky, G., Meßner, H., Grienberger, H., Becker, H., Slave, I., Hauer, Ch., Pakisch, B., Oberbauer, R., Mokry, M., Ebner, F., Kleinert, R., Schiller, D., Kasparu, H., Schneider, G., Sega, W., Lutz, D., Mader, R. M., Steger, G. G., Sieder, A. E., Ovissi, L., Roth, E., Hamilton, G., Jakesz, R., Rainer, H., Schenk, T., Kornek, G., Schulz, F., Depisch, D., Rosen, H., Sebesta, Ch., Scheithauer, W., Locker, G. J., Czernin, J., Derfler, K., Gnant, M., Schiessel, R., Petru, E., Pickel, H., Heydarfadai, M., Lahousen, M., Haas, J., Sagaster, P., Flamm, J., Umek, H., Essl, R., Teich, G., Micksche, M., Ludwig, H., Ambros, P. F., Lestou, V., Strehl, S., Mann, G., Gadner, H., Eibl, B., Greiter, E., Grünewald, K., Gastl, G., Thaler, J., Aulitzky, W., Lion, T., Henn, T., Gaiger, A., Hofmann, J., Wolf, A., Spitaler, M., Ludescher, Christof, Grunicke, H., Mitterbauer, G., Stangl, E., Geissler, K., Jäger, U., Lechner, K., Mannhalter, C., Haas, Oskar A., Tirita, Anthi, Kahls, P., Haas, O., Hinterberger, W., Linkesch, W., Pober, Michael, Fae, Ingrid, Kyrle, Alexander, Neumeister, Andrea, Panzer, Simon, Kandioler, D., End, A., Grill, R., Karlic, H., Inhauser, T., Chott, A., Pirc-Danoewinata, H., Klepetko, W., Heinz, R., Hopfinger-Limberger, G., Koller, E., Schneider, B., Pittermann, E., Lorber, C., Eichinger, S., Neumann, E., Weidinger, J., Gisslinger, H., Bedford P., Jones D., Cawley J., Catovsky D., Bevan P., Scherrer, R., Bettelheim, P., Knöbl, P., Kyrie, P. A., Lazcika, K., Schwarzinger, I., Sillaber, C., Watzke, H., Dávid, M., Losonczy, H., Matolcsy, A., Papp, M., Prischl, F. C., Schwarzmeier, J. D., Zoubek, Andreas, Harbott, Jochen, Ritterbach, Jutta, Ritter, Jörg, Sillaber, Ch., Agis, H., Spanblöchl, E., Sperr, W. R., Valent, P., Czerwenka, K., Virgolini, I., Li, S. R., Müller, M., Wrann, M., Gaggl, S., Fasching, B., Herold, M., Geissler, D., Nachbaur, D., Huber, Ch., Schwaighofer, H., Pichl, M., Niederwieser, D., Gilly, B., Weissel, H., Lorber, Ch., Schwarzmeier, J., Gasché, C., Reinisch, W., Hilgarth, M., Keil, F., Thomssen, C., Kolb, H. J., Holler, E., Wilmanns, W., Tilg, H., Gächter, A., Panzer-Grümayer, E. R., Majdic, O., Kersey, J. H., Petzer, A. L., Bilgeri, R., Zilian, U., Geisen, F. H., Haun, M., Konwalinka, G., Fuchs, D., Zangerle, R., Artner-Dworzak, E., Weiss, G., Fritsch, P., Tilz, G. P., Dierich, M. P., Wachter, H., Schüller, J., Czejka, M. J., Jäger, W., Meyer, B., Weiss, C., Schernthaner, G., Marosi, Ch., Onderka, E., Schlögl, B., Maca, T., Hanak, R., Mannhalter, Ch., Brenner, B., Mayer, R., Langmann, A., Langmann, G., Slave, J., Poier, E., Stücklschweiger, G., Hackl, A., Fritz, A., Pabinger, I., Willfort, A., Groiss, E., Bernhart, M., Waldner, R., Krieger, O., Nowotny, H., Strobl, H., Michlmayr, G., Mistrik, M., lstvan, L., Kapiotis, S., Laczika, K., Speiser, W., Granena, A., Hermans, J., Zwaan, F., Gratwohl, A., Labar B., Mrsić M., Nemet D., Bogdanić V., Radman I., Zupančić-Šalek Silva, Kovačević-Metelko Jasna, Aurer I., Forstinger, C., Scholten, C., Kier, P., Kalhs, P., Schwinger, W., Slavc, I., Lackner, H., Nussbaumer, W., Fritsch, E., Fink, M., Zechner, O., Kührer, I., Kletter, V., Frey, S., Leitgeb, C., Fritz, E., Silly, H., Brezinschek, R., Kuss, I., Stöger, H., Schmid, M., Samonigg, H., Wilders-Truschnig, M., Schmidt, F., Bauernhofer, T., Kasparek, A. K., Ploner, F., Stoeger, H., Moser, R., Leikauf, W., Klemm, F., Pfeffel, F., Niessner, H., Poschauko, H., Pojer, E., Locker, G. J., Braun, J., Gnant, M. F. X., Michl, I., Pirker, R., Liebhard, A., Zielinski, C., Dittrich, C., Bernát, S. I., Pongrácz, E., Kastner, J., Raderer, M., Jorbenyi, Z., Yilmaz, A., Suardet, L., Lahm, H., Odartchenko, N., Varga, Gy., Sréter, L. A., Oberberg, D., Berdel, W. E., Budiman, R., Brand, C., Berkessy, S., Radványi, G., Pauker, Zs., Nagy, Zs., Karádi, Å., Serti, S., Hainz, R., Kirchweger, P., Prager, C., Prada, J., Neifer, S., Bienzle, U., Kremsner, P., Kämmerer, B., Vetterlein, M., Pohl, W., Letnansky, K., Imre, S. 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P., Liu, E., Ritter, M., de Kant, E., Brendel, C., He, M., Dodge, R., George, S., Davey, F., Silver, R., Schiffer, C., Mayer, R., Ball, E., Bloomfield, C., Ramschak, H., Tiran, A., Truschnig-Wilders, M., Nizze, H., Bühring, U., Oelschlägel, U., Jermolow, M., Oertel, J., Weisbach, V., Zingsem, J., Wiens, M., Jessen, J., Osthoff, K., Timm, H., Wilborn, F., Bodak, K., Langmach, K., Bechstein, W., Blumhardt, G., Neuhaus, P., Olek, K., Ottinger, H., Kozole, G., Belka, C., Meusers, P., Hense, J., Papadileris, Stefan, Pasternak, G., Pasternak, L., Karsten, U., Pecherstorfer, M., Zimmer-Roth, I., Poloskey, A., Petrasch, S., Kühnemund, O., Uppenkamp, M., Lütticken, R., Kosco, M., Schmitz, J., Petrides, Petro E., Dittmann, Klaus H., Krieger, O., Pflueger, K. -H., Grueber, A., Schoeneberger, J., Wenzel, E., Havemann, K., Pies, A., Kneba, M., Edel, G., Pohl, S., Bulgay-Mörschel, M., Polzin, R., Issing, W., Clemm, Ch., Schorn, K., Ponta, H., Zöller, M., Hofmann, M., Arch, R., Heider, K. -H., Rudy, W., Tölg, C., Herrlich, P., Prümmer, O., Scherbaum, W. A., Porzsolt, F., Prümmer, O., Krüger, A., Schrezenmeier, H., Schlander, H., Pineo, G., Marin, P., Gluckman, E., Shahidi, N. T., Bacigalupo, A., Ratajczak, M. Z., Gewirtz, A. M., Ratei, R., Borner, K., Bank, U., Bühling, F., Reisbach, G., Bartke, L., Kempkes, B., Kostka, G., Ellwart, X., Birner, A., Bornkamm, G. W., Ullrich, A., Dörmer, P., Henze, G., Parwaresch, R., Müller-Weihrich, S. T., Klingebiel, Th., Odenwald, E., Brandhorst, D., Tsuruo, T., Wetter, O., Renner, C., Pohl, C., Sahin, U., Renner, U., Zeller, K. -P., Repp, R., Valerius, Th., Sendler, A., Kalden, J. R., PIatzer, E., Reuss-Borst, M. A., Bühring, H. J., Reuter, C., der Landwehr, II, U. Auf, der Landwehr, II, U. Auf, Schleyer, E., Rolf, C., Ridwelski, K., Matthias, M., Preiss, R., Riewald, M., Puzo, A., Serke, S., Rohrer, B., Pfeiffer, D., Hepp, H., Romanowski, R., Schött, C., Rüther, U., Rothe, B., Pöllmann, H., Nunnensiek, C., Schöllhammer, T., Ulshöfer, Th., Bader, H., Jipp, P., Müller, H. A. G., Rupp, W., Lüthgens, M., Eisenberger, F., Afflerbach, C., Höller, A., Schwamborn, J. S., Daus, H., Krämer, K., Pees, H., Salat, C., Reinhardt, B., Düll, T., Knabe, H., Hiller, E., Sawinski, K., Schalhorn, A., Kühl, M., Heil, K., Schardt, Ch., Drexler, H. G., Scharf, R. E., Suhijar, D., del Zoppo, G. J., Ruggeri, Z. M., Roll, T., Möhler, T., Giselinger, H., Knäbl, P., Kyrie, P. A., Lazcíka, K., Lechner, X., Scheulen, M. E., Beelen, D. W., Reithmayer, H., Daniels, R., Weiherich, A., Quabeck, K., Schaefer, U. W., Reinhardt J., Grimm M., Unterhalt M., Schliesser, G., Lohmeyer, J., Schlingheider, O., von Eiff, M., Schulze, F., Oehme, C., van de Loo, J., Schlögl E., Bemhart M., Schmeiser, Th., Rozdzinski, E., Kern, W., Reichle, A., Moritz, T., Merk, Bruno, Schmid, R. M., Perkins, N. D., Duckett, C. S., Leung, K., Nabel, G. J., Pawlaczyk-Peter, B., Kellermann-Kegreiß, Schmidt E., Steiert, I., Schmidt-Wolf, G., Schmidt-Wolf, I. G. H., Schlegel, P., Blume, K. G., Chao, N. J., Lefterova, P., Laser, J., Schmitz, G., Rothe, G., Schönfeld, S., Schulz, S., Nyce, J. W., Graf, N., Ludwig, R., Steinhauser, I., Brommer, A. E., Qui, H., Schroeder, M., Grote-Kiehn, J., Bückner, U., Rüger, I., Schröder, J., Meusers, P., Weimar, Ch., Schoch, C., Schröter, G., Stern, H., Buchwald, B., Schick, K., Avril, N., Flierdt, E. v. d., Langhammer, H. R., Pabst, H. W., Alvarado, M., Witte, T., Vogt, H., Schuler, U., Brammer, K., Klann, R. C., Schumm, M., Hahn, J., Günther, W., Wullich, B., Moringlane, J. R., Schöndorf, S., Schwartz, S., Bühring, H. -J., Notter, M., Böttcher, S., Martin, M., Schmid, H., Lübbe, A. S., Leib-Mösch C., Wankmüller, H., Eilbrück, D., Funke, I., Cardoso, M., Duranceyk, H., Seitz, R., Rappe, N., Kraus, H., Egbring, R., Haasberg, M., Havemann, K., Seibach, J., Wollscheid, Ursula, Serke, St., Zimmermann, R., Shirai, T., Umeda, M., Anno, S., Kosuge, T., Katoh, M., Moro, S., Su, C. -Y., Shikoshi, K., Arai, N., Schwieder, G., Silling-Engelhardt, G., Zühlsdorf, M., Aguion-Freire-Innig, E., van de Loo, J., Stockdreher, K., Gatsch, L., Tischler, H. -J., Ringe, B., Diedrich, H., Franzi, A., Kruse, E., Lück, R., Trenn, G., Sykora, J., Wen, T., Fung-Leung, W. P., Mak, T. W., Brady, G., Loke, S., Cossman, J., Gascoyne, R., Mak, T., Urasinski, I., Zdziarska, B., Usnarska-Zubkiewicz, L., Kotlarek-Haus, S., Sciborskl, R., Nowosad, H., Kummer, G., Schleucher, N., Preusser, P., Niebel, W., Achterrath, W., Pott, D., Eigler, F. -W., Venook, A., Stagg, R., Frye, J., Gordon, R., Ring, E., Verschuer, U. v., Baur, F., Heit, W., Corrons, J. L. L. Vives, Vogel, M., Nekarda, H., Remy, W., Bissery, M. C., Aapro, M., Buchwald-Pospiech, A., Kaltwasser, J. P., Jacobi, V., de Vos, Sven, Asano, Yoshinobu, Voss, Harald, Knuth, Alexander, Wiedemann, G., Komischke, B., Horisberger, R., Wussow, P. v., Wanders, L., Senekowitsch, R., Strohmeyer, S., Emmerich, B., Selbach, J., Gutensohn, K., Wacker-Backhaus, G., Winkeimann, M., Send, W., Rösche, J., Weide, R., Parviz, B., Havemann, K., Weidmann, B., Henss, H., Engelhardt, R., Bernards, P., Zeidler, D., Jägerbauer, E., Colajori, E., Kerpel-Fronius, S., Weiss, A., Buchheidt, D., Döring, A., D.Saeger, H., Weissbach, L., Emmler, J., Wermes, R., Meusers, P., Flasshove, M., Skorzec, M., Käding, J., Platow, S., Winkler, Ute, Thorpe, Philip, Winter, S. F., Minna, J. D., Nestor, P. J., Johnson, B. E., Gazdar, A. F., Havemann, K., Carbone, D. P., Wit, M. de, Bittner, S., Hossfeld, D., Wittmann, G., Borchelt, M., Steinhagen-Thiessen, E., Koch, K., Brosch, T., Haas, N., Wölfel, C., Knuth, A., Wölfel, T., Safford, M., Könemann, S., Zurlutter, K., Schreiber, K., Piechotka, K., Drescher, M., Toepker, S., Terstappen, L. W. M. M., Bullerdiek, J., Jox, A., zur Hausen, H., Wolters, B., Stenzinger, W., Woźny, T., Sawiński, K., Kozłowska-Skrzypczak, M., Wussow, P. v., Hochhaus, T., Ansarl, H., Prümmer, O., Zapf, H., Thorban, S., Präuer, H., Zeller, W., Stieglitz, J. v., Dürken, M., Greenshaw, C., Kabisch, H., Reuther, C., Knabbe, C., Lippman, M., Havemann, K., Wellstein, A., Degos, L., Castaigne, S., Fenaux, P., Chomienne, C., Raza, A., Preisler, H. D., PEG Interventional Antimicrobial Strategy Study Group, Interventional Antimicrobial Strategy Study Group of the Paul Ehrlich Society (PEG), and H. Riehm for the BFM study group
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33. Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants
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Hehlmann, R., Lauseker, M., Baerlocher, G. M., Heim, D., Brümmendorf, T. H., Fabarius, A., Haferlach, C., Schlegelberger, B., Müller, M. C., Jeromin, S., Proetel, U., Kohlbrenner, K., Saußele, S., Voskanyan, A., Rinaldetti, S., Seifarth, W., Spieß, B., Balleisen, L., Goebeler, M. C., Hänel, M., Ho, A., Dengler, J., Falge, C., Pfirrmann, M., Kanz, L., Kremers, S., Burchert, A., Kneba, M., Stegelmann, F., Köhne, C. A., Lindemann, H. W., Waller, C. F., Pfreundschuh, M., Spiekermann, K., Krause, S., Berdel, W. E., Müller, L., Edinger, M., Mayer, J., Beelen, D. W., Bentz, M., Link, H., Hertenstein, B., Fuchs, Roland, Wernli, M., Kolb, H. J., Schlegel, F., Schlag, R., de Wit, M., Trümper, L., Hebart, H., Hahn, M., Thomalla, J., Scheid, C., Schafhausen, P., Verbeek, W., Neubauer, A., Eckart, M. J., Gassmann, W., Pezzutto, A., Schenk, M., Brossart, P., Geer, T., Bildat, S., Schäfer, E., Hochhaus, A., Hasford, J., Hossfeld, D. K., SAKK and the German CML Study Group, Nerl, C., and Gratwohl, A.
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0301 basic medicine ,Oncology ,medicine.medical_specialty ,Cancer Research ,Medizin ,Alpha interferon ,610 Medicine & health ,03 medical and health sciences ,0302 clinical medicine ,chronic myeloid leukemia ,Internal medicine ,medicine ,Survival analysis ,Relative survival ,business.industry ,Myeloid leukemia ,Imatinib ,Hematology ,medicine.disease ,3. Good health ,Surgery ,Leukemia ,030104 developmental biology ,Imatinib mesylate ,030220 oncology & carcinogenesis ,Cytarabine ,Original Article ,business ,medicine.drug - Abstract
Chronic myeloid leukemia (CML)-study IV was designed to explore whether treatment with imatinib (IM) at 400 mg/day (n=400) could be optimized by doubling the dose (n=420), adding interferon (IFN) (n=430) or cytarabine (n=158) or using IM after IFN-failure (n=128). From July 2002 to March 2012, 1551 newly diagnosed patients in chronic phase were randomized into a 5-arm study. The study was powered to detect a survival difference of 5% at 5 years. After a median observation time of 9.5 years, 10-year overall survival was 82%, 10-year progression-free survival was 80% and 10-year relative survival was 92%. Survival between IM400 mg and any experimental arm was not different. In a multivariate analysis, risk group, major-route chromosomal aberrations, comorbidities, smoking and treatment center (academic vs other) influenced survival significantly, but not any form of treatment optimization. Patients reaching the molecular response milestones at 3, 6 and 12 months had a significant survival advantage. For responders, monotherapy with IM400 mg provides a close to normal life expectancy independent of the time to response. Survival is more determined by patients' and disease factors than by initial treatment selection. Although improvements are also needed for refractory disease, more life-time can currently be gained by carefully addressing non-CML determinants of survival. peerReviewed
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- 2017
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34. Ethik-Kommissionen im Kontext von 'Klasse statt Masse'. Möglichkeiten, Herausforderungen, neue Wege
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Strech, D, Hasford, J, and Briel, M
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Ethik-Kommissionen (EKs), die Forschungsanträge begutachten, sind ein wichtiger Akteur, um den Wert medizinischer Forschung zu fördern (increasing value) wie auch unzureichend valide Studien und verzerrte Forschungsergebnisse zu reduzieren (reducing waste) [ref:1]. EKs haben Zugang[zum vollständigen Text gelangen Sie über die oben angegebene URL], Klasse statt Masse – wider die wertlose Wissenschaft; 18. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin
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- 2017
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35. ASSESSMENT OF IMATINIB 400MG AS FIRST LINE TREATMENT OF CHRONIC MYELOID LEUKEMIA: 10-YEAR SURVIVAL RESULTS OF THE RANDOMIZED CML STUDY IV
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Hehlmann, R., Lauseker, M., Saussele, S., Pfirrmann, M., Krause, S., Kolb, H-J, Neubauer, A., Hossfeld, D. K., Nerl, C., Gratwohl, A., Baerlocher, G. M., Heim, D., Fabarius, A., Haferlach, C., Schlegelberger, B., Mueller, M. C., Jeromin, S., Proetel, U., Kohlbrenner, K., Burchert, A., Voskanyan, A., Rinaldetti, S., Goebeler, M., Dengler, J., Ho, A., Falge, C., Kanz, L., Kneba, M., Stegelmann, F., Pfreundschuh, M., Waller, C. F., Spiekermann, K., Fuchs, R., Scheid, C., Haenel, M., Koehne, C-H, Bruemmendorf, H., Lindemann, H-W, Berdel, W. E., Staib, P., Balleisen, L., Brossart, P., Schenk, M., Zankovich, R., Geer, T., Hertenstein, B., Bildat, S., Hochhaus, A., Hasford, J., Hehlmann, R., Lauseker, M., Saussele, S., Pfirrmann, M., Krause, S., Kolb, H-J, Neubauer, A., Hossfeld, D. K., Nerl, C., Gratwohl, A., Baerlocher, G. M., Heim, D., Fabarius, A., Haferlach, C., Schlegelberger, B., Mueller, M. C., Jeromin, S., Proetel, U., Kohlbrenner, K., Burchert, A., Voskanyan, A., Rinaldetti, S., Goebeler, M., Dengler, J., Ho, A., Falge, C., Kanz, L., Kneba, M., Stegelmann, F., Pfreundschuh, M., Waller, C. F., Spiekermann, K., Fuchs, R., Scheid, C., Haenel, M., Koehne, C-H, Bruemmendorf, H., Lindemann, H-W, Berdel, W. E., Staib, P., Balleisen, L., Brossart, P., Schenk, M., Zankovich, R., Geer, T., Hertenstein, B., Bildat, S., Hochhaus, A., and Hasford, J.
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- 2017
36. Digitale Transformation in der Gesundheitsversorgung:Chancen und Optionen der AOK Bayern. Empfehlungen des Wissenschaftlichen Beirats der AOK Bayern
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Landenberger, M.; Benstetter, F.; Ertug, I.; Hasford, J.; Irlstorfer, E.; Kapitza, T.; Klemperer, D.; Sundmacher, L.; Marckmann, G.; Ziegler, A.-G. and Landenberger, M.; Benstetter, F.; Ertug, I.; Hasford, J.; Irlstorfer, E.; Kapitza, T.; Klemperer, D.; Sundmacher, L.; Marckmann, G.; Ziegler, A.-G.
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- 2017
37. A methodological comparison of two European primary care databases and replication in a US claims database: inhaled long-acting beta-2-agonists and the risk of acute myocardial infarction
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Maciel Afonso, Ana, Schmiedl, S., Becker, Claudia, Tcherny-Lessenot, S., Primatesta, P., Plana, E., Souverein, P., Wang, Y., Korevaar, J.C., Hasford, J., Reynolds, R., de Groot, M.C.H., Schlienger, R., Klungel, O., Rottenkolber, M., Pharmacoepidemiology and Clinical Pharmacology, Sub Pharmacoepidemiology, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology and Clinical Pharmacology, Sub Pharmacoepidemiology, and Sub Pharmacotherapy, Theoretical
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Databases, Factual ,diagnosis ,proportional hazards model ,data analysis ,Myocardial Infarction ,computer.software_genre ,Long-acting beta-2-agonists ,Pulmonary Disease, Chronic Obstructive ,hazard ratio ,0302 clinical medicine ,data base ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,COPD ,Database ,beta 2 adrenergic receptor stimulating agent ,Hazard ratio ,primary medical care ,General Medicine ,Secondary data analysis ,Europe ,comorbidity ,Research Design ,bronchodilating agent ,Acute myocardial infarction ,03 medical and health sciences ,Administration, Inhalation ,Journal Article ,Humans ,Comparative Study ,controlled study ,human ,replication study ,Adrenergic beta-2 Receptor Agonists ,Asthma ,Pharmacology ,prescription ,Primary Health Care ,Proportional hazards model ,business.industry ,disease model ,Secondary data ,asthma ,clinical study ,gold ,medicine.disease ,Comorbidity ,Confidence interval ,United States ,acute heart infarction ,030228 respiratory system ,confidence interval ,exposure ,Methodological comparison ,Observational study ,observational study ,business ,computer ,chronic obstructive lung disease ,muscarinic receptor blocking agent - Abstract
Purpose: Results from observational studies on inhaled long-acting beta-2-agonists (LABA) and acute myocardial infarction (AMI) risk are conflicting, presumably due to variation in methodology. We aimed to evaluate the impact of applying a common study protocol on consistency of results in three databases. Methods: In the primary analysis, we included patients from two GP databases (Dutch—Mondriaan, UK—CPRD GOLD) with a diagnosis of asthma and/or COPD and at least one inhaled LABA or a “non-LABA inhaled bronchodilator medication” (short-acting beta-2-agonist or short-/long-acting muscarinic antagonist) prescription between 2002 and 2009. A claims database (USA—Clinformatics) was used for replication. LABA use was divided into current, recent (first 91 days following the end of a treatment episode), and past use (after more than 91 days following the end of a treatment episode). Adjusted hazard ratios (AMI-aHR) and 95 % confidence intervals (95 % CI) were estimated using time-dependent multivariable Cox regression models stratified by recorded diagnoses (asthma, COPD, or both asthma and COPD). Results: For asthma or COPD patients, no statistically significant AMI-aHRs (age- and sex-adjusted) were found in the primary analysis. For patients with both diagnoses, a decreased AMI-aHR was found for current vs. recent LABA use in the CPRD GOLD (0.78; 95 % CI 0.68–0.90) and in Mondriaan (0.55; 95 % CI 0.28–1.08), too. The replication study yielded similar results. Adjusting for concomitant medication use and comorbidities, in addition to age and sex, had little impact on the results. Conclusions: By using a common protocol, we observed similar results in the primary analysis performed in two GP databases and in the replication study in a claims database. Regarding differences between databases, a common protocol facilitates interpreting results due to minimized methodological variations. However, results of multinational comparative observational studies might be affected by bias not fully addressed by a common protocol.
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- 2016
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38. Interferon alfa versus chemotherapy for chronic myeloid leukemia: a meta-analysis of seven randomized trials
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Delannoy, A, KluinNelemans, JC, Louwagie, A, Stryckmanns, P, Suciu, S, Hehlmann, R, Heimpel, H, Hasford, J, Zuffa, E, Baccarani, M, Tura, S, Ohnishi, K, Ohno, R, Allan, N, Shepherd, P, Broustet, A, Alison, R, Clarke, M, Duong, H, Gray, R, Greaves, E, Peto, R, Richards, S, Sinclair, D, and Wheatley, K
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Cancer Research ,Oncology - Published
- 2016
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39. Autologous stem cell transplantation in chronic myeloid leukaemia: A meta-analysis of six randomized trials
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Smith, G, Olavarria, E, Richards, S, Apperley, J, Carella, A, Nierderweiser, D, Rowe, J, Tallman, M, Hehlmann, R, Hasford, J, Berger, U, Pfirrmann, M, Goldman, J, O'Brien, S, Reiffers, J, Fort, M-P, Mahon, F, Boque, C, Sureda, A, and Collaboration, CMLAT
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- 2016
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40. The long term outcome of the patients with chronic myeloid leukemia (CML) who have achieved complete cytogenetic response (CCgR) to interferon-alpha (IFN alpha). A collaborative European study of 317 cases
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Bonifazi, F, De Vivo, A, Rosti, G, Guilhot, F, Guilhot, J, Trabacchi, E, Hehlmann, R, Hochhaus, A, Shepherd, P, Steegmann, J, Kluin-Nelemans, H, Thaler, J, Simonsson, B, Louwagie, A, Reiffers, J, Mahon, F, Montefusco, E, Alimena, G, Hasford, J, Richards, S, Saglio, G, Testoni, N, Martinelli, G, Tura, S, and Baccarani, M
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- 2016
41. Hydroxyurea versus busulphan for chronic myeloid leukaemia: an individual patient data meta-analysis of three randomized trials
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Hehlmann, R, Heimpel, H, Hasford, J, Allan, N, Burnett, A, Shepherd, P, Oberg, G, Simonsson, B, Stromberg, U, Alison, R, Clarke, M, Evans, V, Godwin, J, MacKinnon, E, Richards, S, and Trialist, CML
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- 2016
42. Multi-centre, multi-database studies with common protocols: Lessons learnt from the IMI PROTECT project
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Klungel, Olaf H., Kurz, Xavier, de Groot, Mark C. H., Schlienger, Raymond G., Tcherny-Lessenot, Stephanie, Grimaldi, Lamiae, Ibáñez, Luisa, Groenwold, Rolf H. H., Reynolds, Robert F., Alvarez, Y., Candore, G., Durand, J., Slattery, J., Hasford, J., Rottenkolber, M., Schmiedl, S., de Abajo Iglesias, F., Gil, M., Gonzalez, R., Huerta Alvarez, C., Martin, E., Oliva, B., Requena, G., Amelio, J., Brauer, R., Downey, G., Feudjo-Tepie, M., Schoonen, M., Johansson, S., Robinson, J., Gallagher, A., Ng, E., van Staa, T.P., Davis, K., Abbing-Karahagopian, V., Ali, S., Belitser, S., de Boer, Anthonius, De Bruin, M.L., Egberts, A.C.G., van Dijk, L., Gardarsdottir, H., Leufkens, H.G.M., Souverein, P., Uddin, J., van den Ham, H.A., Voogd, E., de Vries, Frank, Udo, R., Sub Pharmacotherapy, Theoretical, Sub Gen. Pharmacoepi and Clinical Pharm, Sub Pharmacoepidemiology, Sub Clinical Pharmacy, Pharmacoepi, and Pharmacoepidemiology and Clinical Pharmacology
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Pharmacoepidemiology (PE) ,pharmacoepidemiology ,anticonvulsive agent ,study design ,data base ,European Medicines Agency ,Taverne ,antibiotic agent ,antidepressant agent ,human ,Innovative Medicines Initiative ,replication study ,Observational studies ,outcome assessment ,suicide ,benzodiazepine derivative ,long acting drug ,beta 2 adrenergic receptor stimulating agent ,Methodology ,tricyclic antidepressant agent ,article ,asthma ,case control study ,long acting beta 2 adrenergic receptor stimulating agent ,unclassified drug ,acute heart infarction ,confounding variable ,calcium channel blocking agent ,priority journal ,risk factor ,PROTECT ,hip fracture ,depression ,serotonin uptake inhibitor ,epilepsy ,observational study ,Electronic healthcare databases ,clinical protocol ,chronic obstructive lung disease ,neoplasm ,liver injury - Abstract
Purpose: To assess the impact of a variety of methodological parameters on the association between six drug classes and five key adverse events in multiple databases. Methods: The selection of Drug-Adverse Event pairs was based on public health impact, regulatory relevance, and the possibility to study a broad range of methodological issues. Common protocols and data analytical specifications were jointly developed and independently and blindly executed in different databases in Europe with replications in the same and different databases. Results: The association between antibiotics and acute liver injury, benzodiazepines and hip fracture, antidepressants and hip fracture, inhaled long-acting beta2-agonists and acute myocardial infarction was consistent in direction across multiple designs, databases and methods to control for confounding. Some variation in magnitude of the associations was observed depending on design, exposure and outcome definitions, but none of the differences were statistically significant. The association between anti-epileptics and suicidality was inconsistent across the UK CPRD, Danish National registries and the French PGRx system. Calcium channel blockers were not associated with the risk of cancer in the UK CPRD, and this was consistent across different classes of calcium channel blockers, cumulative durations of use up to >10years and different types of cancer. Conclusions: A network for observational drug effect studies allowing the execution of common protocols in multiple databases was created. Increased consistency of findings across multiple designs and databases in different countries will increase confidence in findings from observational drug research and benefit/risk assessment of medicines.
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- 2016
43. Tiotropium Respimat© vs. HandiHaler©: Real-life usage and TIOSPIR trial generalizability
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Schmiedl, S., Fischer, R., Ibáñez, L., Fortuny, J., Thuermann, P.A., Ballarin, E., Ferrer, P., Sabaté, M., Rottenkolber, D., Gerlach, R., Tauscher, M., Reynolds, R., Hasford, J., and Rottenkolber, M.
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Copd ,Real-life Usage ,Secondary Data Analysis ,Tiospir Trial ,Tiotropium - Abstract
Aim: Two inhaler devices (Respimat (R) and HandiHaler (R)) are available for tiotropium, a long acting anticholinergic agent. We aimed to analyze drug utilization, off-label usage and generalizability of the TIOSPIR trial results for both devices. MethodsPatients aged 18years exhibiting at least one documented prescription of tiotropium in the database of the Association of Statutory Health Insurance Physicians, Bavaria, Germany, were included (years 2004-2008). Annual period prevalence rates (PPRs) were calculated stratified by age, gender and inhaler devices. Off-label usage (patients lacking a chronic obstructive pulmonary disease (COPD) diagnosis) and the proportion of patients meeting the inclusion and exclusion criteria of the TIOSPIR trial were analyzed. ResultsBetween 2004 and 2008, PPRs increased and varied between 49.2 and 74.5 per 10000 persons for HandiHaler (R) and between 1.5 and 9.3 per 10000 persons for Respimat (R). Small differences regarding patient characteristics existed between the two inhaler devices. Only about 30% (HandiHaler (R) 32.1%, Respimat (R) 30.0%) of the database patients receiving tiotropium could be theoretically included in the TIOSPIR trial. ConclusionsComparing the two tiotropium devices, no clinically relevant differences regarding patient and prescribing characteristics were revealed. Results of the TIOSPIR trial were generalizable only to a minority of our study patients, underlining the need for real-life data.
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- 2016
44. Relative Überlebenswahrscheinlichkeiten bei chronischer myeloischer Leukämie im Vergleich mit kumulativen Inzidenzwahrscheinlichkeiten an der Erkrankung zu versterben
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Pfirrmann, M, Hoffmann, V, Lauseker, M, and Hasford, J
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kumualtive Inzidenzwahrscheinlichkeiten ,ddc: 610 ,relative Überlebenswahrscheinlichkeiten ,610 Medical sciences ,Medicine - Abstract
Einleitung: Die Einführung von Tyrosinkinaseinhibitoren zu Beginn dieses Jahrtausends revolutionierte die Behandlung von chronischer myeloischer Leukämie (CML). Für den ersten zugelassenen Tyrosinkinaseinhibitor, Imatinib, wurden zu acht Jahren Überlebenswahrscheinlichkeiten von [zum vollständigen Text gelangen Sie über die oben angegebene URL], GMDS 2015; 60. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS)
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- 2015
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45. ANALYSIS OF TREATMENT AND OUTCOME DATA OF 2904 PATIENTS FROM THE EUTOS POPULATION-BASED REGISTRY
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Hoffmann, V. S., Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., Di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A., Zaritskey, A., Andrija Bogdanovic, Sninska, Z., Zupan, I., Steegmann, J. -L, Simonsson, B., Clark, R., and Hehlmann, R.
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- 2015
46. Seasonal changes in prescribing of longacting beta-2-agonists-containing drugs
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Rottenkolber, M., Voogd, E., van Dijk, L., Primatesta, P., Becker, C., de Groot, M.C.H., Plana, E., Alvarez, Y., Durand, J., Slattery, J., Afonso, A., Requena, G., Huerta, C., Alvarez, A., de Abajo, F., Tauscher, M., Hasford, J., Fischer, R., Reynolds, R., and Schmiedl, S.
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Life ,Long-acting beta-2 agonists ,RAPID - Risk Analysis for Products in Development ,COPD ,Food and Nutrition ,Seasonal variations ,ELSS - Earth, Life and Social Sciences ,Healthy Living ,Asthma ,Secondary data analysis ,respiratory tract diseases ,Nutrition - Abstract
Background: For patients with asthma, COPD, or asthma-COPD overlap syndrome (ACOS), inter-country comparisons of seasonal changes in drug prescriptions are scarce or missing. Hence, we aimed to compare seasonal changes in prescription rates of long-acting beta-2-agonist (LABA) in four European countries. Methods: A common study protocol was applied to six health care databases (Germany, Spain, the Netherlands (2), and the UK (2)) to calculate age- and sex-standardized point prevalence rates (PPRs) of LABA-containing prescriptions by the 1st of March, June, September, and December of each year during the study period 2002e2009. Seasonal variation of PPRs was quantified using seasonal indexes (SIs; based on the ratio-to-moving-average-method) and SIs averaged over the study period (aSI) stratified by sex, age, and indication (asthma, COPD, or ACOS). Results: There was a moderate seasonal change in LABA-containing prescriptions which was more pronounced in asthma or COPD patients compared to ACOS patients. For asthma and ACOS patients, highest seasonal variation was found for patients living in Spain (aSI: 87.3e110.7, aSI: 93.2e103.1) whereas for COPD highest seasonal variation was revealed for the NPCRD database (the Netherlands) (aSI: 92.2e105.6). Regarding age and sex, highest seasonal variation was found in Spanish boys under 10 years of age having a diagnosis of asthma. Conclusions: By applying a common analysis in six databases, we could observe moderate overall seasonal changes in LABA-containing prescription rates in patients with asthma, COPD, or ACOS.
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- 2015
47. Prognosis of long-term survival considering disease-specific death in patients with chronic myeloid leukemia
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Pfirrmann, M., Baccarani, M., Saussele, S., Guilhot, J., Cervantes, F., Ossenkoppele, G., Hoffmann, V. S., Castagnetti, F., Hasford, J., Hehlmann, R., Simonsson, Bengt, Pfirrmann, M., Baccarani, M., Saussele, S., Guilhot, J., Cervantes, F., Ossenkoppele, G., Hoffmann, V. S., Castagnetti, F., Hasford, J., Hehlmann, R., and Simonsson, Bengt
- Abstract
In patients with chronic myeloid leukemia (CML), first-line imatinib treatment leads to 8-year overall survival (OS) probabilities above 80%. Many patients die of reasons unrelated to CML. This work tackled the reassessment of prognosis under particular consideration of the probabilities of dying of CML. Analyses were based on 2290 patients with chronic phase CML treated with imatinib in six clinical trials. 'Death due to CML' was defined by death after disease progression. At 8 years, OS was 89%. Of 208 deceased patients, 44% died of CML. Higher age, more peripheral blasts, bigger spleen and low platelet counts were significantly associated with increased probabilities of dying of CML and determined a new long-term survival score with three prognostic groups. Compared with the low-risk group, the patients of the intermediate-and the high-risk group had significantly higher probabilities of dying of CML. The score was successfully validated in an independent sample of 1120 patients. In both samples, the new score differentiated probabilities of dying of CML better than the Sokal, Euro and the European Treatment and Outcome Study (EUTOS) score. The new score identified 61% low-risk patients with excellent long-term outcome and 12% high-risk patients. The new score supports the prospective assessment of long-term antileukemic efficacy and risk-adapted treatment.
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- 2016
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48. A methodological comparison of two European primary care databases and replication in a US claims database : inhaled long-acting beta-2-agonists and the risk of acute myocardial infarction
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Afonso, A., Schmiedl, S., Becker, C., Tcherny-Lessenot, S., Primatesta, P., Plana, E., Souverein, P., Wang, Y., Korevaar, J. C., Hasford, J., Reynolds, R., de Groot, M. C H, Schlienger, R., Klungel, O., Rottenkolber, M., Afonso, A., Schmiedl, S., Becker, C., Tcherny-Lessenot, S., Primatesta, P., Plana, E., Souverein, P., Wang, Y., Korevaar, J. C., Hasford, J., Reynolds, R., de Groot, M. C H, Schlienger, R., Klungel, O., and Rottenkolber, M.
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- 2016
49. Long-term outcome of patients with newly diagnosed chronic myeloid leukemia: a randomized comparison of stem cell transplantation with drug treatment
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Gratwohl, A., Pfirrmann, M., Zander, A., Kroger, N., Beelen, D., Novotny, J., Nerl, C., Scheid, C., Spiekermann, K., Mayer, J., Sayer, H. G., Falge, C., Bunjes, D., Doehner, H., Ganser, A., Schmidt-Wolf, I., Schwerdtfeger, R., Baurmann, H., Kuse, R., Schmitz, N., Wehmeier, A., Fischer, J. Th, Ho, A. D., Wilhelm, M., Goebeler, M-E, Lindemann, H. W., Bormann, M., Hertenstein, B., Schlimok, G., Baerlocher, G. M., Aul, C., Pfreundschuh, M., Fabian, M., Staib, P., Edinger, M., Schatz, M., Fauser, A., Arnold, R., Kindler, T., Wulf, G., Rosselet, A., Hellmann, A., Schaefer, E., Pruemmer, O., Schenk, M., Hasford, J., Heimpel, H., Hossfeld, D. K., Kolb, H-J, Buesche, G., Haferlach, C., Schnittger, S., Mueller, M. C., Reiter, A., Berger, U., Saussele, S., Hochhaus, A., Hehlmann, R., Gratwohl, A., Pfirrmann, M., Zander, A., Kroger, N., Beelen, D., Novotny, J., Nerl, C., Scheid, C., Spiekermann, K., Mayer, J., Sayer, H. G., Falge, C., Bunjes, D., Doehner, H., Ganser, A., Schmidt-Wolf, I., Schwerdtfeger, R., Baurmann, H., Kuse, R., Schmitz, N., Wehmeier, A., Fischer, J. Th, Ho, A. D., Wilhelm, M., Goebeler, M-E, Lindemann, H. W., Bormann, M., Hertenstein, B., Schlimok, G., Baerlocher, G. M., Aul, C., Pfreundschuh, M., Fabian, M., Staib, P., Edinger, M., Schatz, M., Fauser, A., Arnold, R., Kindler, T., Wulf, G., Rosselet, A., Hellmann, A., Schaefer, E., Pruemmer, O., Schenk, M., Hasford, J., Heimpel, H., Hossfeld, D. K., Kolb, H-J, Buesche, G., Haferlach, C., Schnittger, S., Mueller, M. C., Reiter, A., Berger, U., Saussele, S., Hochhaus, A., and Hehlmann, R.
- Abstract
Tyrosine kinase inhibitors represent today's treatment of choice in chronic myeloid leukemia (CML). Allogeneic hematopoietic stem cell transplantation (HSCT) is regarded as salvage therapy. This prospective randomized CML-study IIIA recruited 669 patients with newly diagnosed CML between July 1997 and January 2004 from 143 centers. Of these, 427 patients were considered eligible for HSCT and were randomized by availability of a matched family donor between primary HSCT (group A; N = 166 patients) and best available drug treatment (group B; N = 261). Primary end point was long-term survival. Survival probabilities were not different between groups A and B (10-year survival: 0.76 (95% confidence interval (CI): 0.69-0.82) vs 0.69 (95% CI: 0.61-0.76)), but influenced by disease and transplant risk. Patients with a low transplant risk showed superior survival compared with patients with high( P < 0.001) and non-high-risk disease (P = 0.047) in group B; after entering blast crisis, survival was not different with or without HSCT. Significantly more patients in group A were in molecular remission (56% vs 39%; P = 0.005) and free of drug treatment (56% vs 6%; P < 0.001). Differences in symptoms and Karnofsky score were not significant. In the era of tyrosine kinase inhibitors, HSCT remains a valid option when both disease and transplant risk are considered.
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- 2016
50. A methodological comparison of two European primary care databases and replication in a US claims database: inhaled long-acting beta-2-agonists and the risk of acute myocardial infarction
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Pharmacoepidemiology and Clinical Pharmacology, Sub Pharmacoepidemiology, Sub Pharmacotherapy, Theoretical, Maciel Afonso, Ana, Schmiedl, S., Becker, Claudia, Tcherny-Lessenot, S., Primatesta, P., Plana, E., Souverein, P., Wang, Y., Korevaar, J.C., Hasford, J., Reynolds, R., de Groot, M.C.H., Schlienger, R., Klungel, O., Rottenkolber, M., Pharmacoepidemiology and Clinical Pharmacology, Sub Pharmacoepidemiology, Sub Pharmacotherapy, Theoretical, Maciel Afonso, Ana, Schmiedl, S., Becker, Claudia, Tcherny-Lessenot, S., Primatesta, P., Plana, E., Souverein, P., Wang, Y., Korevaar, J.C., Hasford, J., Reynolds, R., de Groot, M.C.H., Schlienger, R., Klungel, O., and Rottenkolber, M.
- Published
- 2016
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