ID

16249

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

  1. 7/7/16 7/7/16 -
  2. 7/7/16 7/7/16 -
  3. 7/7/16 7/7/16 -
  4. 7/11/16 7/11/16 -
  5. 7/11/16 7/11/16 -
  6. 7/12/16 7/12/16 -
  7. 8/3/16 8/3/16 -
  8. 12/7/17 12/7/17 -
  9. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  10. 9/20/21 9/20/21 -
Uploaded on

July 7, 2016

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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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.

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

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.

SAE date of report
Description

Datum der Meldung

Data type

date

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1302584
SAE number
Description

2-digit number for the identification of the Suez.

Data type

integer

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0237753
Report type
Description

Typ der Meldung

Data type

integer

Alias
UMLS CUI-1
C0585733
Patient's Data
Description

Patient's Data

Age
Description

Alter

Data type

integer

Measurement units
  • Years
Alias
UMLS CUI-1
C0001779
Years
Gender
Description

Geschlecht

Data type

integer

Alias
UMLS CUI-1
C0079399
Weight
Description

Gewicht

Data type

float

Measurement units
  • kg
Alias
UMLS CUI-1
C0005910
kg
Height
Description

height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI-1
C0005890
cm
Pregnancy
Description

Schwangerschaft

Data type

integer

Alias
UMLS CUI-1
C0549206
Weeks pregnant
Description

Schwangerschaftswoche

Data type

integer

Alias
UMLS CUI-1
C0460089
Treatment
Description

Treatment

SAE Treatment
Description

Behandlung

Data type

integer

Alias
UMLS CUI-1
C2981656
SAE Treatment Description
Description

andere Behandlung

Data type

string

Alias
UMLS CUI-1
C2981656
relevant preexcisting diseases/ symptoms
Description

relevant preexcisting diseases/ symptoms

Preexisting disease or symptom
Description

multimor_1

Data type

text

Alias
UMLS CUI [1]
C0009488
Start date
Description

mordata_1

Data type

partialDate

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0009488
End date
Description

mordatb_1

Data type

partialDate

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0009488
Relevant Diagnostic Test Result
Description

Relevant Diagnostic Test Result

Relevant Diagnostic Test Result
Description

Resultate der relevanten diagnostischen Tests

Data type

string

Alias
UMLS CUI-1
C0456984
Name of reporter
Description

Name of reporter

Name of reporter
Description

Berichterstatters

Data type

string

Alias
UMLS CUI-1
C2826892
Phone number
Description

Telefonnummer

Data type

string

Alias
UMLS CUI-1
C0039457
Fax number
Description

Faxnummer

Data type

string

Alias
UMLS CUI-1
C1549619
Email
Description

Email

Data type

string

Alias
UMLS CUI-1
C0013849
Signature
Description

Signature

Data type

text

Alias
UMLS CUI-1
C1519316
Information on Adverse Events
Description

Information on Adverse Events

Event (diagnostic or symptomatic)
Description

aeterm

Data type

text

Alias
UMLS CUI [1]
C0877248
SAE Description
Description

Beschreibung SUE

Data type

string

Alias
UMLS CUI-1
C2699044
Further information Adverse Event
Description

Further information Adverse Event

Date occured
Description

aestdtc

Data type

date

Alias
UMLS CUI [1]
C2697888
The side effect / the disease event is permanently / chronic?
Description

Dauerhaft

Data type

integer

Alias
UMLS CUI [1]
C2826792
If stopped, when?
Description

aeendtc

Data type

date

Alias
UMLS CUI [1]
C2697886
What was the intensity the event?
Description

aesev

Data type

integer

Alias
UMLS CUI [1]
C1710066
Severity of Event
Description

Severity of Event

Was the event serious?
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
Why serious?
Description

Kriterien für den Schweregrad

Data type

integer

Alias
UMLS CUI [1]
C1519275
Outcome
Description

Outcome

Outcome of the event?
Description

aeout

Data type

integer

Alias
UMLS CUI [1]
C1705586
If permanent consequences, which
Description

aeouttx

Data type

text

Alias
UMLS CUI [1]
C1320829
Date of death
Description

Todesdatum

Data type

date

Alias
UMLS CUI [1]
C1148348
Cause
Description

Ursache

Data type

text

Alias
UMLS CUI [1]
C0007465
Autopsy
Description

Autopsie

Data type

integer

Alias
UMLS CUI [1]
C0004398
Causality (UE & MS-Medication)
Description

Causality (UE & MS-Medication)

How likely is a causal link between the event and the current MS therapy?
Description

aerel

Data type

integer

Alias
UMLS CUI [1,1]
C0871675
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2827774
UMLS CUI [1,4]
C0026769
Multiple Sclerosis Medication
Description

Multiple Sclerosis Medication

Multiple Sclerosis Medication
Description

MS-Medikament

Data type

integer

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0026769
Other
Description

Anderes MS-Medikament

Data type

text

Alias
UMLS CUI [1,1]
C1115771
UMLS CUI [1,2]
C0026769
Ingestion start date
Description

Einnahme seit

Data type

partialDate

Alias
UMLS CUI-1
C0451613
End date
Description

Einnahme bis

Data type

partialDate

Alias
UMLS CUI-1
C1531784
Daily dose
Description

Tagesdosis

Data type

float

Alias
UMLS CUI-1
C2348070
Unit
Description

Einheit

Data type

integer

Alias
UMLS CUI-1
C1519795
Action
Description

Maßnahme

Data type

integer

Alias
UMLS CUI [1]
C2169461
Causality
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
Causality (UE & Concomittant Medication)
Description

Causality (UE & Concomittant Medication)

How likely is a causal link between the event and another currently approved drug?
Description

aerelAnderes

Data type

integer

Alias
UMLS CUI [1,1]
C0871675
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2347852
Concomittant Medication
Description

Concomittant Medication

Concomitant medication
Description

Andere Medikation

Data type

string

Alias
UMLS CUI-1
C2347852
Start date
Description

Einnahme seit

Data type

partialDate

Alias
UMLS CUI [1]
C2826734
End date
Description

bis

Data type

partialDate

Alias
UMLS CUI-1
C2826744
Daily dose
Description

Tagesdosis

Data type

float

Alias
UMLS CUI-1
C2348070
Unit
Description

Einheit

Data type

integer

Alias
UMLS CUI-1
C1519795
Indication
Description

Indikation

Data type

string

Alias
UMLS CUI-1
C3146298
Causality
Description

Kausalität

Data type

integer

Alias
UMLS CUI [1,1]
C0871675
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2347852

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.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
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.
Datum der Meldung
Item
SAE date of report
date
C1519255 (UMLS CUI-1)
C1302584 (UMLS CUI-2)
SUE-Nummer
Item
SAE number
integer
C1519255 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Report type
integer
C0585733 (UMLS CUI-1)
Code List
Report type
CL Item
First report (1)
CL Item
Follow-Up report (2)
Item Group
Patient's Data
Alter
Item
Age
integer
C0001779 (UMLS CUI-1)
Item
Gender
integer
C0079399 (UMLS CUI-1)
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Gewicht
Item
Weight
float
C0005910 (UMLS CUI-1)
height
Item
Height
integer
C0005890 (UMLS CUI-1)
Item
Pregnancy
integer
C0549206 (UMLS CUI-1)
Code List
Pregnancy
CL Item
Yes (1)
CL Item
No (0)
Schwangerschaftswoche
Item
Weeks pregnant
integer
C0460089 (UMLS CUI-1)
Item Group
Treatment
Item
SAE Treatment
integer
C2981656 (UMLS CUI-1)
Code List
SAE Treatment
CL Item
No (0)
CL Item
Treatment with medication (1)
CL Item
Other (2)
andere Behandlung
Item
SAE Treatment Description
string
C2981656 (UMLS CUI-1)
Item Group
relevant preexcisting diseases/ symptoms
multimor_1
Item
Preexisting disease or symptom
text
C0009488 (UMLS CUI [1])
mordata_1
Item
Start date
partialDate
C0808070 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
mordatb_1
Item
End date
partialDate
C0806020 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Item Group
Relevant Diagnostic Test Result
Resultate der relevanten diagnostischen Tests
Item
Relevant Diagnostic Test Result
string
C0456984 (UMLS CUI-1)
Item Group
Name of reporter
Berichterstatters
Item
Name of reporter
string
C2826892 (UMLS CUI-1)
Telefonnummer
Item
Phone number
string
C0039457 (UMLS CUI-1)
Faxnummer
Item
Fax number
string
C1549619 (UMLS CUI-1)
Email
Item
Email
string
C0013849 (UMLS CUI-1)
Signature
Item
Signature
text
C1519316 (UMLS CUI-1)
Item Group
Information on Adverse Events
Item
Event (diagnostic or symptomatic)
text
C0877248 (UMLS CUI [1])
Code List
Event (diagnostic or symptomatic)
CL Item
-Heart / cardiovascular disease (01)
CL Item
High blood pressure (02)
CL Item
Heart failure/insufficiency (03)
CL Item
Heart rhythm disorder (04)
CL Item
Heart attack (05)
CL Item
CHD / Angina Pectoris (06)
CL Item
Vein thrombosis (07)
CL Item
Pulmonary embolism (08)
CL Item
-Metabolic disorders (10)
CL Item
Diabetes mellitus (11)
CL Item
Thyroid under or overactive (12)
CL Item
-Infectious diseases (20)
CL Item
Hepatitis B or C (21)
CL Item
HIV infection (22)
CL Item
Tuberculosis (23)
CL Item
Opportunistic infections (24)
CL Item
Herpes infection (25)
CL Item
PML (26)
CL Item
Lung inflammation (27)
CL Item
-Gastrointestinal diseases (30)
CL Item
Pancreatic inflammation (31)
CL Item
Cirrhosis of the liver (32)
CL Item
Crohn's disease (33)
CL Item
Ulcerative colitis (34)
CL Item
-Neurological disorders (40)
CL Item
Epileptic seizures (41)
CL Item
Depression (42)
CL Item
Angsstörungen, panic attacks (43)
CL Item
Migraine / headache (44)
CL Item
Anorexia (45)
CL Item
-Allergies (50)
CL Item
Drug allergy (51)
CL Item
House dust / pollen (52)
CL Item
Food (53)
CL Item
Nickel / fragrances (54)
CL Item
Insect bites (55)
CL Item
-Kidney / Genitourinary disease (60)
CL Item
Recurrent urinary tract infections (61)
CL Item
Impaired renal function (62)
CL Item
-Autoimmune diseases (70)
CL Item
Myasthenia gravis (71)
CL Item
Autoimmune thyroid disease (72)
CL Item
Systemic Lupus Erythematosus (73)
CL Item
Psoriasis (74)
CL Item
-Blood / lab changes (80)
CL Item
Anemia (81)
CL Item
Lymphopenia (82)
CL Item
Leukopenia (83)
CL Item
Neutropenia (84)
CL Item
Coagulation disorders (85)
CL Item
Myelodysplastic syndrome (86)
CL Item
Saliency in Lebertest(s) (87)
CL Item
Saliency in Nierentest(s) (88)
CL Item
-General symptoms (90)
CL Item
Hair loss (91)
CL Item
Skin rash (92)
CL Item
local symptoms with medications (93)
CL Item
Retinopathy, macular edema (94)
CL Item
Joint pain (95)
CL Item
Weight loss or gain (96)
CL Item
Others (-1)
Beschreibung SUE
Item
SAE Description
string
C2699044 (UMLS CUI-1)
Item Group
Further information Adverse Event
aestdtc
Item
Date occured
date
C2697888 (UMLS CUI [1])
Item
The side effect / the disease event is permanently / chronic?
integer
C2826792 (UMLS CUI [1])
Code List
The side effect / the disease event is permanently / chronic?
CL Item
Yes (1)
CL Item
No (0)
aeendtc
Item
If stopped, when?
date
C2697886 (UMLS CUI [1])
Item
What was the intensity the event?
integer
C1710066 (UMLS CUI [1])
Code List
What was the intensity the event?
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item Group
Severity of Event
Item
Was the event serious?
integer
C1519275 (UMLS CUI [1])
Code List
Was the event serious?
CL Item
Yes (1)
CL Item
No (0)
Item
Why serious?
integer
C1519275 (UMLS CUI [1])
Code List
Why serious?
CL Item
Results in death (1)
CL Item
life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Congenital anomaly/birth defect (4)
CL Item
Results in disability/incapacity (5)
CL Item
Other medical important event (6)
Item Group
Outcome
Item
Outcome of the event?
integer
C1705586 (UMLS CUI [1])
Code List
Outcome of the event?
CL Item
prolonged (1)
CL Item
Recovered (2)
CL Item
Recovered with Sequelae (3)
CL Item
death (4)
CL Item
unknown (-1)
aeouttx
Item
If permanent consequences, which
text
C1320829 (UMLS CUI [1])
Todesdatum
Item
Date of death
date
C1148348 (UMLS CUI [1])
Ursache
Item
Cause
text
C0007465 (UMLS CUI [1])
Item
Autopsy
integer
C0004398 (UMLS CUI [1])
Code List
Autopsy
CL Item
yes (1)
CL Item
no (0)
CL Item
unknown (-1)
Item Group
Causality (UE & MS-Medication)
Item
How likely is a causal link between the event and the current MS therapy?
integer
C0871675 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2827774 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
Code List
How likely is a causal link between the event and the current MS therapy?
CL Item
not leviable (-1)
CL Item
not causal (0)
CL Item
unlikely (1)
CL Item
possible (2)
CL Item
probable (3)
CL Item
causal (4)
Item Group
Multiple Sclerosis Medication
Item
Multiple Sclerosis Medication
integer
C2360065 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
Code List
Multiple Sclerosis Medication
CL Item
Alemtuzumab (Lemtrada) (22)
C0383429 (UMLS CUI-1)
CL Item
Azathioprine (2)
C0004482 (UMLS CUI-1)
CL Item
Cyclophosphamide (4)
C0010583 (UMLS CUI-1)
CL Item
Fingolimod (Gilenya) (18)
C1699926 (UMLS CUI-1)
CL Item
Fumarate (BG-12; Tecfidera) (24)
C0058218 (UMLS CUI-1)
CL Item
COPAXONE (Copaxone) (6)
C0289884 (UMLS CUI-1)
CL Item
Immune Globulins (7)
C0021027 (UMLS CUI-1)
CL Item
Interferon ß-1A (Avonex) (19)
C0254119 (UMLS CUI-1)
C0021492 (UMLS CUI-2)
CL Item
Interferon ß-1A SC (Rebif 22 µg, Rebif 44 µg) (20)
C0254119 (UMLS CUI-1)
CL Item
Interferon ß 1SC (Betaseron, Extavia) (21)
C0244713 (UMLS CUI-1)
CL Item
* Medication from a MS study (8)
C0013175 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
CL Item
Methotrexate (9)
C0025677 (UMLS CUI-1)
CL Item
Mitoxantrone (10)
C0026259 (UMLS CUI-1)
CL Item
Natalizumab (Tysabri) (11)
C1172734 (UMLS CUI-1)
CL Item
Rituximab (14)
C0393022 (UMLS CUI-1)
CL Item
Teriflunomide (Aubagio) (23)
C1718383 (UMLS CUI-1)
CL Item
Cortisone (25)
C0010137 (UMLS CUI-1)
CL Item
Others... (99)
C1115771 (UMLS CUI-1)
Anderes MS-Medikament
Item
Other
text
C1115771 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
Einnahme seit
Item
Ingestion start date
partialDate
C0451613 (UMLS CUI-1)
Einnahme bis
Item
End date
partialDate
C1531784 (UMLS CUI-1)
Tagesdosis
Item
Daily dose
float
C2348070 (UMLS CUI-1)
Item
Unit
integer
C1519795 (UMLS CUI-1)
Code List
Unit
CL Item
mg (2)
CL Item
µg (4)
Item
Action
integer
C2169461 (UMLS CUI [1])
Code List
Action
CL Item
no (0)
CL Item
Dose reduced (1)
CL Item
Dose increased (2)
CL Item
Disruption of medication (3)
CL Item
Medication discontinued (4)
Item
Causality
integer
C0871675 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2827774 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
Code List
Causality
CL Item
not leviable (-1)
CL Item
not causal (0)
CL Item
unlikely (1)
CL Item
possible (2)
CL Item
probable (3)
CL Item
causal (4)
Item Group
Causality (UE & Concomittant Medication)
Item
How likely is a causal link between the event and another currently approved drug?
integer
C0871675 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Code List
How likely is a causal link between the event and another currently approved drug?
CL Item
not leviable (-1)
CL Item
not causal (0)
CL Item
unlikely (1)
CL Item
possible (2)
CL Item
probable (3)
CL Item
causal (4)
Item Group
Concomittant Medication
Andere Medikation
Item
Concomitant medication
string
C2347852 (UMLS CUI-1)
Einnahme seit
Item
Start date
partialDate
C2826734 (UMLS CUI [1])
bis
Item
End date
partialDate
C2826744 (UMLS CUI-1)
Tagesdosis
Item
Daily dose
float
C2348070 (UMLS CUI-1)
Item
Unit
integer
C1519795 (UMLS CUI-1)
Code List
Unit
CL Item
mg (2)
CL Item
µg (4)
Indikation
Item
Indication
string
C3146298 (UMLS CUI-1)
Item
Causality
integer
C0871675 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Code List
Causality
CL Item
not leviable (-1)
CL Item
not causal (0)
CL Item
unlikely (1)
CL Item
possible (2)
CL Item
probable (3)
CL Item
causal (4)

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