ID

44604

Description

Schwerwiegendes unerwünschtes Ereignis (SUE) in der Therapie SUE Berichtsformular Bitte ausfüllen und faxen oder senden an: Westfälische Wilhelms-Universität Münster, Institut für Epidemiologie und Sozialmedizin, Albert-Schweitzer-Campus 1, Gebäude 03, 48149 Münster Fax: (0251) 83-55300, E-Mail: regims@uni-muenster.de http://epi.uni-muenster.de

Link

http://epi.uni-muenster.de

Keywords

Versions (8)
  1. 12/15/14 12/15/14 - Martin Dugas
  2. 12/16/14 12/16/14 - Martin Dugas
  3. 12/17/14 12/17/14 - Martin Dugas
  4. 12/17/14 12/17/14 - Martin Dugas
  5. 1/16/15 1/16/15 - Martin Dugas
  6. 2/6/15 2/6/15 -
  7. 6/25/15 6/25/15 - Martin Dugas
  8. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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REGIMS

German English

SUE Report

1 forms  
  1. StudyEvent: SUE Report
    1. SUE Report
SUE
Description

SUE

Alias
UMLS CUI-1
C1519255
SAE number
Description

SUE-Nummer

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
SAE date of report
Description

Datum der Meldung

Data type

date

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1302584
Patientenangaben
Description

Patientenangaben

Age
Description

Age

Data type

integer

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

Gender

Data type

integer

Alias
UMLS CUI-1
C0079399
Weight
Description

Weight

Data type

float

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

Height

Data type

float

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

Pregnancy

Data type

boolean

Alias
UMLS CUI-1
C0549206
Weeks pregnant
Description

Schwangerschaftswoche

Data type

integer

Alias
UMLS CUI-1
C0460089
SUE: Beschreibung
Description

SUE: Beschreibung

SAE Description
Description

Beschreibung SUE

Data type

string

Alias
UMLS CUI-1
C2699044
SAE Start Date
Description

Beginn

Data type

date

Alias
UMLS CUI-1
C2697888
SAE End Date
Description

Enddatum

Data type

date

Alias
UMLS CUI-1
C2697886
SAE Category
Description

Intensität

Data type

integer

Alias
UMLS CUI-1
C2826790
SAE Severity Code
Description

Kriterien für den Schweregrad

Data type

integer

Alias
UMLS CUI-1
C2985921
SUE: Behandlung
Description

SUE: Behandlung

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
SUE: Ausgang
Description

SUE: Ausgang

SAE Outcome
Description

Ausgang

Data type

integer

Alias
UMLS CUI-1
C1705586
Death date
Description

Todesdatum

Data type

date

Alias
UMLS CUI-1
C1148348
Cause of death
Description

Todesursache

Data type

string

Alias
UMLS CUI-1
C0007465
Autopsy performed
Description

Autopsie durchgeführt

Data type

integer

Alias
UMLS CUI-1
C0004398
SUE: MS-Medikation
Description

SUE: MS-Medikation

Multiple Sclerosis Medication
Description

MS-Medikament1

Data type

string

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0026769
Ingestion start date
Description

Einnahme seit

Data type

partialDate

Alias
UMLS CUI-1
C0451613
End date
Description

bis

Data type

partialDate

Alias
UMLS CUI-1
C3483769
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
C3266814
Causality
Description

Kausalität

Data type

integer

Alias
UMLS CUI-1
C1314792
SUE: Begleitmedikation
Description

SUE: Begleitmedikation

Concomitant medication
Description

Andere Medikation

Data type

string

Alias
UMLS CUI-1
C2347852
Ingestion 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

Daily dose

Data type

float

Alias
UMLS CUI-1
C2348070
Unit
Description

Unit

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
C1314792
SUE: Relevante Vorerkrankung / Sypmtome
Description

SUE: Relevante Vorerkrankung / Sypmtome

Preexisting disease or symptom
Description

multimor_1

Data type

integer

Start date
Description

mordata_1

Data type

partialDate

Alias
UMLS CUI-1
C0808070
End date
Description

mordatb_1

Data type

partialDate

Ergebnisse der relevanten Diagnostischen Untersuchungen
Description

Ergebnisse der relevanten Diagnostischen Untersuchungen

Relevant Diagnostic Test Result
Description

Resultate der relevanten diagnostischen Tests

Data type

string

Alias
UMLS CUI-1
C0456984
Kontaktdaten des Berichterstatters
Description

Kontaktdaten des Berichterstatters

Name of reporter
Description

Berichterstatters

Data type

string

Alias
UMLS CUI-1
C1709908
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
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Similar models

SUE Report

1 forms
  1. StudyEvent: SUE Report
    1. SUE Report
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1519255 (UMLS CUI-1)
SUE-Nummer
Item
SAE number
integer
C1519255 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Item
Report type
integer
C0585733 (UMLS CUI-1)
reptyp
Code List
Report type
CL Item
First report (1)
CL Item
Follow-Up report (2)
Datum der Meldung
Item
SAE date of report
date
C1519255 (UMLS CUI-1)
C1302584 (UMLS CUI-2)
Age
Item
Age
integer
C0001779 (UMLS CUI-1)
Item
Gender
integer
C0079399 (UMLS CUI-1)
sex
Code List
Gender
CL Item
male (1)
C0086582 (UMLS CUI-1)
CL Item
female (2)
C0086287 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI-1)
Height
Item
Height
float
C0005890 (UMLS CUI-1)
Pregnancy
Item
Pregnancy
boolean
C0549206 (UMLS CUI-1)
Schwangerschaftswoche
Item
Weeks pregnant
integer
C0460089 (UMLS CUI-1)
Beschreibung SUE
Item
SAE Description
string
C2699044 (UMLS CUI-1)
Beginn
Item
SAE Start Date
date
C2697888 (UMLS CUI-1)
Enddatum
Item
SAE End Date
date
C2697886 (UMLS CUI-1)
Item
SAE Category
integer
C2826790 (UMLS CUI-1)
aesev
Code List
SAE Category
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
SAE Severity Code
integer
C2985921 (UMLS CUI-1)
aesae
Code List
SAE Severity Code
CL Item
No (0)
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
SAE Treatment
integer
C2981656 (UMLS CUI-1)
behand
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
Item
SAE Outcome
integer
C1705586 (UMLS CUI-1)
aeout
Code List
SAE Outcome
CL Item
prolonged (1)
CL Item
Recovered (2)
CL Item
Recovered with Sequelae (3)
CL Item
death (4)
CL Item
unknown (-1)
Todesdatum
Item
Death date
date
C1148348 (UMLS CUI-1)
Todesursache
Item
Cause of death
string
C0007465 (UMLS CUI-1)
Item
Autopsy performed
integer
C0004398 (UMLS CUI-1)
autopsie
Code List
Autopsy performed
CL Item
yes (1)
CL Item
no (0)
CL Item
unknown (-1)
MS-Medikament1
Item
Multiple Sclerosis Medication
string
C0013227 (UMLS CUI-1)
C0026769 (UMLS CUI-2)
Einnahme seit
Item
Ingestion start date
partialDate
C0451613 (UMLS CUI-1)
bis
Item
End date
partialDate
C3483769 (UMLS CUI-1)
Tagesdosis
Item
Daily dose
float
C2348070 (UMLS CUI-1)
Item
Unit
integer
C1519795 (UMLS CUI-1)
cmdosu_1
Code List
Unit
CL Item
mg (1)
CL Item
µg (4)
Item
Action
integer
C3266814 (UMLS CUI-1)
msact_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
C1314792 (UMLS CUI-1)
msrel_1
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)
Andere Medikation
Item
Concomitant medication
string
C2347852 (UMLS CUI-1)
Einnahme seit
Item
Ingestion start date
partialDate
C2826734 (UMLS CUI-1)
bis
Item
End date
partialDate
C2826744 (UMLS CUI-1)
Daily dose
Item
Daily dose
float
C2348070 (UMLS CUI-1)
Item
Unit
integer
C1519795 (UMLS CUI-1)
cmdosu_1
Code List
Unit
CL Item
mg (1)
CL Item
µg (4)
Indikation
Item
Indication
string
C3146298 (UMLS CUI-1)
Item
Causality
integer
C1314792 (UMLS CUI-1)
msrel_1
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)
multimor_1
Item
Preexisting disease or symptom
integer
mordata_1
Item
Start date
partialDate
C0808070 (UMLS CUI-1)
mordatb_1
Item
End date
partialDate
Resultate der relevanten diagnostischen Tests
Item
Relevant Diagnostic Test Result
string
C0456984 (UMLS CUI-1)
Berichterstatters
Item
Name of reporter
string
C1709908 (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)
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