ID
16321
Description
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.
Link
http://campus.uni-muenster.de/index.php?id=6075
Keywords
Versions (10)
- 7/7/16 7/7/16 -
- 7/7/16 7/7/16 -
- 7/7/16 7/7/16 -
- 7/11/16 7/11/16 -
- 7/11/16 7/11/16 -
- 7/12/16 7/12/16 -
- 8/3/16 8/3/16 -
- 12/7/17 12/7/17 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Uploaded on
July 11, 2016
DOI
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License
Creative Commons BY-NC 3.0
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REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016
If the exact date is not known, please take "01" for the day of the start - and depending on the duration of an appropriate day for the end.
- StudyEvent: Baseline
- StudyEvent: Medizinischer Folgebogen
- Note: This form can be printed as a PDF.
- Modul B - Änderungen der MS-Therapie FU1
- Modul C - Schubereignis / Krankheitsprogression FU1
- Note: This form can be created as a PDF. After the Ausgedrucken please before shipment practice add stamp.
- Meldebogen für Schwangerschaft - Teil 2 FU1
- If the exact date is not known, please take "01" for the day of the start - and depending on the duration of an appropriate day for the end.
Description
Further information Adverse Event
Description
aestdtc
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
Dauerhaft
Data type
integer
Alias
- UMLS CUI [1]
- C2826792
Description
aeendtc
Data type
date
Alias
- UMLS CUI [1]
- C2697886
Description
aesev
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Severity of Event
Description
An event is serious, if it's a or several of these sequences has: hospitalization, life-threatening, resulting in death, congenital malformations, handicap / disability or medically important events!
Data type
integer
Alias
- UMLS CUI [1]
- C1519275
Description
Kriterien für den Schweregrad
Data type
integer
Alias
- UMLS CUI [1]
- C1519275
Description
Outcome
Description
aeout
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
aeouttx
Data type
text
Alias
- UMLS CUI [1]
- C1320829
Description
Todesdatum
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Ursache
Data type
text
Alias
- UMLS CUI [1]
- C0007465
Description
Autopsie
Data type
integer
Alias
- UMLS CUI [1]
- C0004398
Description
Causality (UE & MS-Medication)
Description
Multiple Sclerosis Medication
Description
MS-Medikament
Data type
integer
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0026769
Description
Anderes MS-Medikament
Data type
text
Alias
- UMLS CUI [1,1]
- C1115771
- UMLS CUI [1,2]
- C0026769
Description
Einnahme seit
Data type
partialDate
Alias
- UMLS CUI-1
- C0451613
Description
Einnahme bis
Data type
partialDate
Alias
- UMLS CUI-1
- C1531784
Description
Tagesdosis
Data type
float
Alias
- UMLS CUI-1
- C2348070
Description
Einheit
Data type
integer
Alias
- UMLS CUI-1
- C1519795
Description
Maßnahme
Data type
integer
Alias
- UMLS CUI [1]
- C2169461
Description
Kausalität
Data type
integer
Alias
- UMLS CUI [1,1]
- C0871675
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2827774
- UMLS CUI [1,4]
- C0026769
Description
Causality (UE & Concomittant Medication)
Description
Concomittant Medication
Description
Andere Medikation
Data type
string
Alias
- UMLS CUI-1
- C2347852
Description
Einnahme seit
Data type
partialDate
Alias
- UMLS CUI [1]
- C2826734
Description
bis
Data type
partialDate
Alias
- UMLS CUI-1
- C2826744
Description
Tagesdosis
Data type
float
Alias
- UMLS CUI-1
- C2348070
Description
Einheit
Data type
integer
Alias
- UMLS CUI-1
- C1519795
Description
Indikation
Data type
string
Alias
- UMLS CUI-1
- C3146298
Description
Kausalität
Data type
integer
Alias
- UMLS CUI [1,1]
- C0871675
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2347852
Description
Please fill promptly the following fields in case of a serious adverse event (SUE)! After you have entered your name and saved the form, it is "not yet" transferred automatically with all information from the system: as an internal message (in the database) to all participants of your Centre as E-Mail and fax (fax number: 0251-83-55300) to the Westfälische Wilhelms-Universität Münster, Institute of epidemiology and social medicine, Alber-Schweitzer-campus 1, building D3, 48149 Münster.
Description
Datum der Meldung
Data type
date
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1302584
Description
2-digit number for the identification of the Suez.
Data type
integer
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0237753
Description
Typ der Meldung
Data type
integer
Alias
- UMLS CUI-1
- C0585733
Description
Patient's Data
Description
Alter
Data type
integer
Measurement units
- Years
Alias
- UMLS CUI-1
- C0001779
Description
Geschlecht
Data type
integer
Alias
- UMLS CUI-1
- C0079399
Description
Gewicht
Data type
float
Measurement units
- kg
Alias
- UMLS CUI-1
- C0005910
Description
height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI-1
- C0005890
Description
Schwangerschaft
Data type
integer
Alias
- UMLS CUI-1
- C0549206
Description
Schwangerschaftswoche
Data type
integer
Alias
- UMLS CUI-1
- C0460089
Description
Treatment
Description
relevant preexcisting diseases/ symptoms
Description
multimor_1
Data type
text
Alias
- UMLS CUI [1]
- C0009488
Description
mordata_1
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0009488
Description
mordatb_1
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0009488
Description
Relevant Diagnostic Test Result
Description
Name of reporter
Description
Berichterstatters
Data type
string
Alias
- UMLS CUI-1
- C2826892
Description
Telefonnummer
Data type
string
Alias
- UMLS CUI-1
- C0039457
Description
Faxnummer
Data type
string
Alias
- UMLS CUI-1
- C1549619
Description
Data type
string
Alias
- UMLS CUI-1
- C0013849
Description
Signature
Data type
text
Alias
- UMLS CUI-1
- C1519316
Similar models
If the exact date is not known, please take "01" for the day of the start - and depending on the duration of an appropriate day for the end.
- StudyEvent: Baseline
- StudyEvent: Medizinischer Folgebogen
- Note: This form can be printed as a PDF.
- Modul B - Änderungen der MS-Therapie FU1
- Modul C - Schubereignis / Krankheitsprogression FU1
- Note: This form can be created as a PDF. After the Ausgedrucken please before shipment practice add stamp.
- Meldebogen für Schwangerschaft - Teil 2 FU1
- If the exact date is not known, please take "01" for the day of the start - and depending on the duration of an appropriate day for the end.
C0877248 (UMLS CUI [1,2])
C2827774 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C0026769 (UMLS CUI [1,2])
C0021492 (UMLS CUI-2)
C0013227 (UMLS CUI-2)
C0026769 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2827774 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1302584 (UMLS CUI-2)
C0237753 (UMLS CUI-2)
C0009488 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])