STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)
NCT ID: NCT01585298
Last Updated: 2019-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
6998 participants
INTERVENTIONAL
2012-04-29
2016-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fingolimod
Fingolimod 0.5 mg by mouth once daily for 7 days.
FTY720
Interventions
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FTY720
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
* Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.
This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.
\- or patients with rapidly evolving severe RRMS (e.g. \> 2 relapses with disease progression in one year and \> 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).
Exclusion Criteria
* active infections
* pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
* presence of malignancy (other than localized basal cell carcinoma of the skin).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Ostfildern, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Altenholz-Stift, Germany, Germany
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Cologne, North Rhine-Westphalia, Germany
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Flensburg, Schleswig-Holstein, Germany
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Aachen, , Germany
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Aachen, , Germany
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Aalen, , Germany
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Aalen-Wasseralfingen, , Germany
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Abensberg, , Germany
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Achim, , Germany
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Aichach, , Germany
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Altenburg, , Germany
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Alzenau in Unterfranken, , Germany
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Andernach, , Germany
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Asbach, , Germany
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Aschaffenburg, , Germany
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Augsburg, , Germany
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Bad Berka, , Germany
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Bad Hersfeld, , Germany
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Bad Homburg, , Germany
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Bad Honnef, , Germany
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Bad Krozingen, , Germany
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Bad Mergentheim, , Germany
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Bad Saarow, , Germany
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Bad Wildbad, , Germany
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Bamberg, , Germany
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Bayreuth, , Germany
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Berg, , Germany
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Bergisch Gladbach, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Bogen, , Germany
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Bonn, , Germany
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Borna, , Germany
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Bottrop, , Germany
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Böblingen, , Germany
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Braunschweig, , Germany
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Braunschweig, , Germany
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Bremen, , Germany
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Bruchsal, , Germany
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Buchholz, , Germany
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Buchholz in der Nordheide, , Germany
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Butzbach, , Germany
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Celle, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Cologne, , Germany
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Cologne, , Germany
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Delbrück, , Germany
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Dessau, , Germany
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Dillingen, , Germany
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Dillingen, , Germany
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Dortmund, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Düren, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , Germany
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Düsseldorf, , Germany
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Eberswalde, , Germany
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Eisenach, , Germany
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Eisleben Lutherstadt, , Germany
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Eltville, , Germany
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Emden, , Germany
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Emmendingen, , Germany
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Erbach im Odenwald, , Germany
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Erfurt, , Germany
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Erfurt, , Germany
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Erlangen, , Germany
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Eschwege, , Germany
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Essen, , Germany
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Essen, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Freiburg im Breisgau, , Germany
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Friedrichshafen, , Germany
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Fulda, , Germany
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Fulda, , Germany
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Gelnhausen, , Germany
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Gelsenkirchen, , Germany
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Gilching, , Germany
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Gladenbach, , Germany
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Göttingen, , Germany
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Göttingen, , Germany
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Greifswald, , Germany
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Grevenbroich, , Germany
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Griesheim, , Germany
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Guelders, , Germany
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Gummersbach, , Germany
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Gütersloh, , Germany
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Haar, , Germany
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Hagen, , Germany
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Halle, , Germany
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Halle S, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Heidenheim, , Germany
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Herdecke, , Germany
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Herford, , Germany
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Herford, , Germany
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Hildesheim, , Germany
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Homburg, , Germany
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Hoppegarten, , Germany
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Ibbenbueren, , Germany
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Idar-Oberstein, , Germany
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Isselburg-Anholt, , Germany
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Itzehoe, , Germany
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Jena, , Germany
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Jena, , Germany
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Jülich, , Germany
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Kaiserslautern, , Germany
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Kaltenkirchen, , Germany
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Kandel, , Germany
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Karlstadt am Main, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Klingenmünster, , Germany
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Koeln-Longerich, , Germany
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Korbach, , Germany
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Königsbrück, , Germany
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Krefeld, , Germany
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Krefeld, , Germany
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Landshut, , Germany
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Lappersdorf, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leverkusen, , Germany
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Lohr a. Main, , Germany
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Ludwigshafen, , Germany
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Ludwigshafen, , Germany
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Lübeck, , Germany
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Lüneburg, , Germany
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Lünen, , Germany
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Magdeburg, , Germany
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Magdeburg, , Germany
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Mannheim, , Germany
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Mannheim, , Germany
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Mannheim, , Germany
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Marburg, , Germany
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Meisenheim, , Germany
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Minden, , Germany
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Minden, , Germany
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Mittweida, , Germany
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Mosbach, , Germany
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Mönchengladbach, , Germany
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Mönchengladbach, , Germany
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Mülheim, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Münster, , Germany
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Nagold, , Germany
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Naumburg, , Germany
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Neu-Ulm, , Germany
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Neuburg an der Donau, , Germany
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Neuruppin, , Germany
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Neusäß, , Germany
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Neustadt an der Weinstraße, , Germany
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Nordhausen, , Germany
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Nuremberg, , Germany
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Offenbach, , Germany
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Oldenburg, , Germany
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Oldenburg I. Holstein, , Germany
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Osnabrück, , Germany
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Osnabrück, , Germany
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Osnabrück, , Germany
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Öhringen, , Germany
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Paderborn, , Germany
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Papenburg, , Germany
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Pforzheim, , Germany
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Potsdam, , Germany
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Prien am Chiemsee, , Germany
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Quakenbrück, , Germany
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Querfurt, , Germany
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Ravensburg, , Germany
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Recklinghausen, , Germany
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Regensburg, , Germany
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Remscheid, , Germany
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Rostock, , Germany
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Rüdersdorf, , Germany
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Saarbrücken, , Germany
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Saint Ingbert, , Germany
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Sande, , Germany
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Schwalmstadt-Treysa, , Germany
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Schwerin, , Germany
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Siegen, , Germany
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Singen, , Germany
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Sinsheim, , Germany
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Solingen, , Germany
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Stade, , Germany
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Stadtroda, , Germany
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Stralsund, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Telgte, , Germany
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Teupitz, , Germany
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Troisdorf, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Ulm, , Germany
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Unterhaching, , Germany
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Wasserburg, , Germany
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Wendlingen, , Germany
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Wermsdorf, , Germany
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Westerstede, , Germany
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Westerstede/Oldenburg, , Germany
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Wiesbaden, , Germany
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Wiesbaden, , Germany
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Wolfratshausen, , Germany
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Wuppertal, , Germany
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Wuppertal, , Germany
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Würzburg, , Germany
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Würzburg, , Germany
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Zwickau, , Germany
Countries
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References
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Limmroth V, Ziemssen T, Lang M, Richter S, Wagner B, Haas J, Schmidt S, Gerbershagen K, Lassek C, Klotz L, Hoffmann O, Albert C, Schuh K, Baier-Ebert M, Wendt G, Schieb H, Hoyer S, Dechend R, Haverkamp W. Electrocardiographic assessments and cardiac events after fingolimod first dose - a comprehensive monitoring study. BMC Neurol. 2017 Jan 18;17(1):11. doi: 10.1186/s12883-016-0789-7.
Other Identifiers
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CFTY720DDE17
Identifier Type: -
Identifier Source: org_study_id
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