ID

43480

Description

German CML Study Group http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

Link

http://www.kompetenznetz-leukaemie.de/content/teilprojekte/studiengruppen/cml_projekt_7/projektleitung/index_ger.html

Keywords

Versions (2)
  1. 6/26/13 6/26/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Bogen 2 Adverse events DRKS00005243 NCT01657604 CML

German English

Bogen 2 Adverse events

1 forms  
  1. StudyEvent: CML
    1. Bogen 2 Adverse events
General information
Description

General information

Alias
UMLS CUI 2011AB
C0332118
SNOMEDCT_2012_01_31
106227002
Hospital number
Description

Klinik-Nr.

Data type

integer

Alias
UMLS CUI 2011AB
C0806432
LOINC Version 232
MTHU008536
Patient number
Description

Patienten-Nr.

Data type

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Birth Date Month:
Description

Geburtsdatum Monat:

Data type

integer

Alias
UMLS CUI 2011AB
CL372179
UMLS CUI 2011AB
C0439231
SNOMEDCT_2012_01_31
258706009
HL7 V3 2006_05
MO
Birth Date Year:
Description

Geburtsdatum Jahr:

Data type

integer

Alias
UMLS CUI 2011AB
CL372179
UMLS CUI 2011AB
C0439234
SNOMEDCT_2012_01_31
258707000
HL7 V3 2006_05
Y
Assessment Date
Description

Beurteilungsdatum

Data type

date

Alias
UMLS CUI 2011AB
C2985720
Flow sheet number
Description

Nummer des Verlaufsbogens

Data type

integer

Alias
UMLS CUI 2011AB
C1299501
SNOMEDCT_2012_01_31
371536005
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
Sex
Description

Geschlecht

Data type

integer

Alias
UMLS CUI 2011AB
C0079399
SNOMEDCT_2012_01_31
263495000
LOINC Version 232
MTHU002975
Adverse events occurred:
Description

Unerwünschte Nebenwirkungen sind aufgetreten:

Data type

boolean

Alias
UMLS CUI 2011AB
C0879626
SNOMEDCT_2012_01_31
281647001
MedDRA 14.1
10067484
UMLS CUI 2011AB
C2745955
SNOMEDCT_2012_01_31
246454002
Patient currently pregnant:
Description

Liegt eine Schwangerschaft vor:

Data type

boolean

Alias
UMLS CUI 2011AB
C0549206
SNOMEDCT_2012_01_31
77386006
MedDRA 14.1
10036586
Adverse events
Description

Adverse events

Alias
UMLS CUI 2011AB
C0879626
SNOMEDCT_2012_01_31
281647001
MedDRA 14.1
10067484
No.
Description

Nr.

Data type

integer

Alias
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
CTCAE Grade
Description

CTCAE-Schweregrad

Data type

integer

Alias
UMLS CUI 2011AB
C1516728
Date of 1st occurrence
Description

Datum des 1. Auftretens

Data type

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
UMLS CUI 2011AB
C0205435
SNOMEDCT_2012_01_31
255216001
UMLS CUI 2011AB
C2745955
SNOMEDCT_2012_01_31
246454002
End of occurrence
Description

Ende des Auftretens

Data type

date

Alias
UMLS CUI 2011AB
C1272693
SNOMEDCT_2012_01_31
385656004
UMLS CUI 2011AB
C2745955
SNOMEDCT_2012_01_31
246454002
Present
Description

Bestehend

Data type

boolean

Alias
UMLS CUI 2011AB
C0150312
SNOMEDCT_2012_01_31
52101004
Therapy-related
Description

Therapiebezug

Data type

boolean

Alias
UMLS CUI 2011AB
C0039798
UMLS CUI 2011AB
C0699792
SNOMEDCT_2012_01_31
263498003
Activities
Description

Maßnahmen

Data type

integer

Alias
UMLS CUI 2011AB
C0441655
SNOMEDCT_2012_01_31
257733005
LOINC Version 232
MTHU002837
ICD-9-CM Version 2011
E001-E030.9
Serious adverse event:
Description

Schwerwiegende unerwünschte Nebenwirkung:

Data type

boolean

Alias
UMLS CUI 2011AB
C0205404
SNOMEDCT_2012_01_31
42745003
UMLS CUI 2011AB
C0879626
SNOMEDCT_2012_01_31
281647001
MedDRA 14.1
10067484
If serious adverse event:
Description

If serious adverse event:

Progression
Description

Verlauf

Data type

integer

Alias
UMLS CUI 2011AB
C0242656
SNOMEDCT_2012_01_31
246453008
MedDRA 14.1
10061818
Consequences (Disability/Physical handicap)
Description

Folgen (Behinderung/Körperliche Einschränkungen)

Data type

boolean

Alias
UMLS CUI 2011AB
C0686907
SNOMEDCT_2012_01_31
103332005
UMLS CUI 2011AB
C0231170
SNOMEDCT_2012_01_31
21134002
MedDRA 14.1
10013050
HL7 V3 2006_05
DIS
UMLS CUI 2011AB
C0520817
SNOMEDCT_2012_01_31
32572006
MedDRA 14.1
10048624
Congenital anomaly/Birth defect
Description

Kongenitale Anomalie/Geburtsfehler

Data type

boolean

Alias
UMLS CUI 2011AB
C0000768
SNOMEDCT_2012_01_31
107656002
MedDRA 14.1
10010356
ICD-10-CM Version 2010
Q89.9
ICD-9-CM Version 2011
759.9
Inpatient admission/Prolongation of existing hospitalization
Description

stationäre Aufnahme/Verlängerung bestehender stationärer Aufenthalt

Data type

boolean

Alias
UMLS CUI 2011AB
C0021562
SNOMEDCT_2012_01_31
416800000
LOINC Version 232
MTHU015923
UMLS CUI 2011AB
C0184666
SNOMEDCT_2012_01_31
32485007
UMLS CUI 2011AB
CL436783
Medically significant
Description

Medizinisch signifikant

Data type

boolean

Alias
UMLS CUI 2011AB
C0205476
SNOMEDCT_2012_01_31
74188005
UMLS CUI 2011AB
C0750502
SNOMEDCT_2012_01_31
386134007
Comment
Description

Comment

Comment:
Description

Kommentar

Data type

string

Alias
UMLS CUI 2011AB
C0947611
LOINC Version 232
MTHU013736
Clinic:
Description

Klinik

Data type

string

Alias
UMLS CUI 2011AB
C0442592
SNOMEDCT_2012_01_31
257585005
Date:
Description

Datum

Data type

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Signature:
Description

Unterschrift

Data type

string

Alias
UMLS CUI 2011AB
C1519316
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Similar models

Bogen 2 Adverse events

1 forms
  1. StudyEvent: CML
    1. Bogen 2 Adverse events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
C0332118 (UMLS CUI 2011AB)
106227002 (SNOMEDCT_2012_01_31)
Klinik-Nr.
Item
Hospital number
integer
C0806432 (UMLS CUI 2011AB)
MTHU008536 (LOINC Version 232)
Patienten-Nr.
Item
Patient number
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Geburtsdatum Monat:
Item
Birth Date Month:
integer
CL372179 (UMLS CUI 2011AB)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
MO (HL7 V3 2006_05)
Geburtsdatum Jahr:
Item
Birth Date Year:
integer
CL372179 (UMLS CUI 2011AB)
C0439234 (UMLS CUI 2011AB)
258707000 (SNOMEDCT_2012_01_31)
Y (HL7 V3 2006_05)
Beurteilungsdatum
Item
Assessment Date
date
C2985720 (UMLS CUI 2011AB)
Nummer des Verlaufsbogens
Item
Flow sheet number
integer
C1299501 (UMLS CUI 2011AB)
371536005 (SNOMEDCT_2012_01_31)
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
Item
Sex
integer
C0079399 (UMLS CUI 2011AB)
263495000 (SNOMEDCT_2012_01_31)
MTHU002975 (LOINC Version 232)
Geschlecht
Code List
Sex
CL Item
male (1)
C0086582 (UMLS CUI 2011AB)
248153007 (SNOMEDCT_2012_01_31)
CL Item
female (2)
C0086287 (UMLS CUI 2011AB)
248152002 (SNOMEDCT_2012_01_31)
Unerwünschte Nebenwirkungen sind aufgetreten:
Item
Adverse events occurred:
boolean
C0879626 (UMLS CUI 2011AB)
281647001 (SNOMEDCT_2012_01_31)
10067484 (MedDRA 14.1)
C2745955 (UMLS CUI 2011AB)
246454002 (SNOMEDCT_2012_01_31)
Liegt eine Schwangerschaft vor:
Item
Patient currently pregnant:
boolean
C0549206 (UMLS CUI 2011AB)
77386006 (SNOMEDCT_2012_01_31)
10036586 (MedDRA 14.1)
Item Group
Adverse events
C0879626 (UMLS CUI 2011AB)
281647001 (SNOMEDCT_2012_01_31)
10067484 (MedDRA 14.1)
Nr.
Item
No.
integer
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
CTCAE-Schweregrad
Item
CTCAE Grade
integer
C1516728 (UMLS CUI 2011AB)
Datum des 1. Auftretens
Item
Date of 1st occurrence
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
C2745955 (UMLS CUI 2011AB)
246454002 (SNOMEDCT_2012_01_31)
Ende des Auftretens
Item
End of occurrence
date
C1272693 (UMLS CUI 2011AB)
385656004 (SNOMEDCT_2012_01_31)
C2745955 (UMLS CUI 2011AB)
246454002 (SNOMEDCT_2012_01_31)
Bestehend
Item
Present
boolean
C0150312 (UMLS CUI 2011AB)
52101004 (SNOMEDCT_2012_01_31)
Therapiebezug
Item
Therapy-related
boolean
C0039798 (UMLS CUI 2011AB)
C0699792 (UMLS CUI 2011AB)
263498003 (SNOMEDCT_2012_01_31)
Item
Activities
integer
C0441655 (UMLS CUI 2011AB)
257733005 (SNOMEDCT_2012_01_31)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
Maßnahmen
Code List
Activities
CL Item
No activities taken (1)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
C0441655 (UMLS CUI 2011AB)
257733005 (SNOMEDCT_2012_01_31)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
CL Item
Drug discontinued (2)
C0013227 (UMLS CUI 2011AB)
MTHU038481 (LOINC Version 232)
C1444662 (UMLS CUI 2011AB)
410546004 (SNOMEDCT_2012_01_31)
CL Item
Intake of concomitant drug (3)
C1512806 (UMLS CUI 2011AB)
C2347852 (UMLS CUI 2011AB)
CL Item
No drug treatment received (4)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
C0013216 (UMLS CUI 2011AB)
416608005 (SNOMEDCT_2012_01_31)
10063370 (MedDRA 14.1)
MTHU010425 (LOINC Version 232)
DRUG (HL7 V3 2006_05)
CL Item
Inpatient admission/Prolongation of existing hospitalization (5)
C0021562 (UMLS CUI 2011AB)
416800000 (SNOMEDCT_2012_01_31)
MTHU015923 (LOINC Version 232)
C0184666 (UMLS CUI 2011AB)
32485007 (SNOMEDCT_2012_01_31)
CL436783 (UMLS CUI 2011AB)
Schwerwiegende unerwünschte Nebenwirkung:
Item
Serious adverse event:
boolean
C0205404 (UMLS CUI 2011AB)
42745003 (SNOMEDCT_2012_01_31)
C0879626 (UMLS CUI 2011AB)
281647001 (SNOMEDCT_2012_01_31)
10067484 (MedDRA 14.1)
Item Group
If serious adverse event:
Item
Progression
integer
C0242656 (UMLS CUI 2011AB)
246453008 (SNOMEDCT_2012_01_31)
10061818 (MedDRA 14.1)
Verlauf
Code List
Progression
CL Item
Fatal (1)
C1302234 (UMLS CUI 2011AB)
399166001 (SNOMEDCT_2012_01_31)
CL Item
Life Threatening (2)
C2826244 (UMLS CUI 2011AB)
Folgen (Behinderung/Körperliche Einschränkungen)
Item
Consequences (Disability/Physical handicap)
boolean
C0686907 (UMLS CUI 2011AB)
103332005 (SNOMEDCT_2012_01_31)
C0231170 (UMLS CUI 2011AB)
21134002 (SNOMEDCT_2012_01_31)
10013050 (MedDRA 14.1)
DIS (HL7 V3 2006_05)
C0520817 (UMLS CUI 2011AB)
32572006 (SNOMEDCT_2012_01_31)
10048624 (MedDRA 14.1)
Kongenitale Anomalie/Geburtsfehler
Item
Congenital anomaly/Birth defect
boolean
C0000768 (UMLS CUI 2011AB)
107656002 (SNOMEDCT_2012_01_31)
10010356 (MedDRA 14.1)
Q89.9 (ICD-10-CM Version 2010)
759.9 (ICD-9-CM Version 2011)
stationäre Aufnahme/Verlängerung bestehender stationärer Aufenthalt
Item
Inpatient admission/Prolongation of existing hospitalization
boolean
C0021562 (UMLS CUI 2011AB)
416800000 (SNOMEDCT_2012_01_31)
MTHU015923 (LOINC Version 232)
C0184666 (UMLS CUI 2011AB)
32485007 (SNOMEDCT_2012_01_31)
CL436783 (UMLS CUI 2011AB)
Medizinisch signifikant
Item
Medically significant
boolean
C0205476 (UMLS CUI 2011AB)
74188005 (SNOMEDCT_2012_01_31)
C0750502 (UMLS CUI 2011AB)
386134007 (SNOMEDCT_2012_01_31)
Item Group
Comment
Kommentar
Item
Comment:
string
C0947611 (UMLS CUI 2011AB)
MTHU013736 (LOINC Version 232)
Klinik
Item
Clinic:
string
C0442592 (UMLS CUI 2011AB)
257585005 (SNOMEDCT_2012_01_31)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Unterschrift
Item
Signature:
string
C1519316 (UMLS CUI 2011AB)
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