REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016

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.

Follow Up Adverse Events

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Information on Adverse Events
C0877248 (UMLS CUI-1)
Item
Event (diagnostic or symptomatic)
text
C0877248 (UMLS CUI [1])
Code List
Event (diagnostic or symptomatic)
CL Item
Heart / cardiovascular disease (01)
C0007222 (UMLS CUI-1)
(Comment:en)
CL Item
High blood pressure (02)
C0020538 (UMLS CUI-1)
(Comment:en)
CL Item
Heart failure/insufficiency (03)
C0392173 (UMLS CUI-1)
(Comment:en)
CL Item
Heart rhythm disorder (04)
C0003811 (UMLS CUI-1)
(Comment:en)
CL Item
Heart attack (05)
C0027051 (UMLS CUI-1)
(Comment:en)
CL Item
CHD / Angina Pectoris (06)
C0010068 (UMLS CUI-1)
(Comment:en)
CL Item
Vein thrombosis (07)
C0149871 (UMLS CUI-1)
(Comment:en)
CL Item
Pulmonary embolism (08)
C0034065 (UMLS CUI-1)
(Comment:en)
CL Item
Metabolic disorders (10)
C0025517 (UMLS CUI-1)
(Comment:en)
CL Item
Diabetes mellitus (11)
C0011849 (UMLS CUI-1)
(Comment:en)
CL Item
Thyroid under or overactive (12)
C0040128 (UMLS CUI-1)
(Comment:en)
CL Item
Infectious diseases (20)
C0009450 (UMLS CUI-1)
(Comment:en)
CL Item
Hepatitis B or C (21)
C0019163 (UMLS CUI-1)
C0019196 (UMLS CUI-2)
(Comment:en)
CL Item
HIV infection (22)
C0019693 (UMLS CUI-1)
(Comment:en)
CL Item
Tuberculosis (23)
C0041296 (UMLS CUI-1)
(Comment:en)
CL Item
Opportunistic infections (24)
C0029118 (UMLS CUI-1)
(Comment:en)
CL Item
Herpes infection (25)
C0019372 (UMLS CUI-1)
(Comment:en)
CL Item
PML (26)
C0023524 (UMLS CUI-1)
(Comment:en)
CL Item
Pneumonia (27)
C0032285 (UMLS CUI-1)
(Comment:en)
CL Item
Gastrointestinal diseases (30)
C0017178 (UMLS CUI-1)
(Comment:en)
CL Item
Pancreatic inflammation (31)
C0030305 (UMLS CUI-1)
(Comment:en)
CL Item
Cirrhosis of the liver (32)
C0023890 (UMLS CUI-1)
(Comment:en)
CL Item
Crohn's disease (33)
C0010346 (UMLS CUI-1)
(Comment:en)
CL Item
Ulcerative colitis (34)
C0009324 (UMLS CUI-1)
(Comment:en)
CL Item
Neurological disorders (40)
C0027765 (UMLS CUI-1)
(Comment:en)
CL Item
Epileptic seizures (41)
C0036572 (UMLS CUI-1)
(Comment:en)
CL Item
Depression (42)
C0011581 (UMLS CUI-1)
(Comment:en)
CL Item
panic attacks (43)
C0497330 (UMLS CUI-1)
(Comment:en)
CL Item
Migraine / headache (44)
C0149931 (UMLS CUI-1)
C0018681 (UMLS CUI-2)
(Comment:en)
CL Item
Anorexia (45)
C0003123 (UMLS CUI-1)
(Comment:en)
CL Item
Allergies (50)
C0020517 (UMLS CUI-1)
(Comment:en)
CL Item
Drug allergy (51)
C0013182 (UMLS CUI-1)
(Comment:en)
CL Item
House dust / pollen (52)
C0339808 (UMLS CUI-1)
C1548336 (UMLS CUI-2)
(Comment:en)
CL Item
Food (53)
C0016470 (UMLS CUI-1)
(Comment:en)
CL Item
Nickel / fragrances (54)
C1690547 (UMLS CUI-1)
C0577618 (UMLS CUI-2)
(Comment:en)
CL Item
Insect bites (55)
C0854051 (UMLS CUI-1)
(Comment:en)
CL Item
Kidney / Genitourinary disease (60)
C0080276 (UMLS CUI-1)
(Comment:en)
CL Item
Recurrent urinary tract infections (61)
C0262655 (UMLS CUI-1)
(Comment:en)
CL Item
Impaired renal function (62)
C1565489 (UMLS CUI-1)
(Comment:en)
CL Item
Autoimmune diseases (70)
C0004364 (UMLS CUI-1)
(Comment:en)
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
C0877248 (UMLS CUI-1)
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
C1519275 (UMLS CUI-1)
Item
Was the event serious?
integer
C1519255 (UMLS CUI [1])
Code List
Was the event serious?
CL Item
Yes (1)
CL Item
No (0)
Item
Why serious?
integer
C1519255 (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
C1705586 (UMLS CUI-1)
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)
C0871675 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C2827774 (UMLS CUI-3)
C0026769 (UMLS CUI-4)
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
text
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)
C0871675 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C2347852 (UMLS CUI-3)
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
C2347852 (UMLS CUI-1)
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)
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
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
C2707520 (UMLS CUI-1)
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
C2981656 (UMLS CUI-1)
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
C0009488 (UMLS CUI-1)
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
C0456984 (UMLS CUI-1)
Resultate der relevanten diagnostischen Tests
Item
Relevant Diagnostic Test Result
string
C0456984 (UMLS CUI-1)
Item Group
Contact details of reporter
C1709908 (UMLS CUI-1)
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)