ID

4590

Beschrijving

A randomized, multi-center phase II trial to assess the efficacy of 5-azacytidine added to standard primary therapy in elderly patients with newly diagnosed AML

Trefwoorden

Versies (2)
  1. 16-12-13 16-12-13 -
  2. 17-09-21 17-09-21 -
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16 december 2013

DOI

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Creative Commons BY-NC 3.0 Legacy
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Unerwünschtes Ereignis (AE) - Blatt Nr.: 1 EudraCT-Nr 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3

Duits Engels

Unerwünschtes Ereignis (AE) - Blatt Nr.: 1

1 Formulieren  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Unerwünschtes Ereignis (AE) - Blatt Nr.: 1
Patient data
Beschrijving

Patient data

Alias
UMLS CUI 2011AB
C2707520
LOINC Version 232
MTHU031990
Pat. No.: -
Beschrijving

Pat. No.

Datatype

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Adverse event
Beschrijving

Adverse event

Alias
Code-1
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
ongoing AE-no.
Beschrijving

fortlaufende AE-Nr.

Datatype

integer

Alias
Code-1
ongoing
UMLS CUI 2011AB
C0750536
Code-2
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
Code-3
Number
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
Adverse event
Beschrijving

Unerwünschtes Ereignis (AE)

Datatype

string

Alias
Code-1
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
Start date AE (Day Month Year)
Beschrijving

Beginn AE Datum

Datatype

date

Alias
Code-1
Start date
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Code-2
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
serious 0-2
Beschrijving

Schwerwiegend

Datatype

integer

Alias
Code-1
Serious
UMLS CUI 2011AB
C0205404
SNOMEDCT_2012_01_31
42745003
Activities regarding investigational drug
Beschrijving

Maßnahmen bzgl. Prüfmedikation

Datatype

integer

Alias
Code-1
Activities
UMLS CUI 2011AB
C0441655
SNOMEDCT_2012_01_31
257733005
LOINC Version 232
MTHU002837
ICD-9-CM Version 2011
E001-E030.9
Code-2
Related
UMLS CUI 2011AB
C0699792
SNOMEDCT_2012_01_31
263498003
Code-3
Investigational Drug
UMLS CUI 2011AB
C0013230
Adverse Event Caused Study Discontinuation
Beschrijving

AE führt zum Studienabbruch

Datatype

boolean

Alias
UMLS CUI 2011AB
C2826233
Relationship with investigational drug
Beschrijving

Zusammenhang mit Prüfmedikation

Datatype

integer

Alias
Code-1
Relationship
UMLS CUI 2011AB
C0699792
SNOMEDCT_2012_01_31
263498003
Code-2
Investigational Drug
UMLS CUI 2011AB
C0013230
CTCAE grading 1-5
Beschrijving

CTCAE-Grading

Datatype

integer

Alias
Code-1
CTCAE
UMLS CUI 2011AB
C1516728
End AE - Documentation of tracing: - up to 30 days after study termination/discontinuation - not required in case of later new occurrences of AEs
Beschrijving

End AE - Documentation of tracing: - up to 30 days after study termination/discontinuation - not required in case of later new occurrences of AEs

Alias
Code-1
End date
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Code-2
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
End date
Beschrijving

Ende Datum

Datatype

date

Alias
Code-1
End date
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Code-2
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
[or] ongoing (ongoing at end of documentation task)
Beschrijving

[oder] anhaltend (anhaltend bei Ende der Dokum.-pflicht)

Datatype

integer

Alias
Code-1
Continue
UMLS CUI 2011AB
C0750536
Code-2
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
Outcome of AE 0-5
Beschrijving

Ausgang des AE

Datatype

integer

Alias
Code-1
Outcome
UMLS CUI 2011AB
C1274040
SNOMEDCT_2012_01_31
394617004
Code-2
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
Signature
Beschrijving

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Beschrijving

Datum

Datatype

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Name/Signature study physician
Beschrijving

Name/Unterschrift Prüfarzt

Datatype

string

Alias
Code-1
Name
UMLS CUI 2011AB
C0027365
LOINC Version 232
MTHU008539
Code-2
Signature
UMLS CUI 2011AB
C1519316
Code-3
Study
UMLS CUI 2011AB
C0008976
SNOMEDCT_2012_01_31
110465008
Code-4
Physician
UMLS CUI 2011AB
C0031831
SNOMEDCT_2012_01_31
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
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Similar models

Unerwünschtes Ereignis (AE) - Blatt Nr.: 1

1 Formulieren
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Unerwünschtes Ereignis (AE) - Blatt Nr.: 1
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Patient data
C2707520 (UMLS CUI 2011AB)
MTHU031990 (LOINC Version 232)
Pat. No.
Item
Pat. No.: -
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Item Group
Adverse event
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
fortlaufende AE-Nr.
Item
ongoing AE-no.
integer
ongoing (Code-1)
C0750536 (UMLS CUI 2011AB)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Number (Code-3)
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
Unerwünschtes Ereignis (AE)
Item
Adverse event
string
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Beginn AE Datum
Item
Start date AE (Day Month Year)
date
Start date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Item
serious 0-2
integer
Serious (Code-1)
C0205404 (UMLS CUI 2011AB)
42745003 (SNOMEDCT_2012_01_31)
Schwerwiegend
Code List
serious 0-2
CL Item
No (0)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Yes - SAE registered (1)
yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
Serious Adverse Event (Code-2)
C1519255 (UMLS CUI 2011AB)
registered (Code-3)
C1514821 (UMLS CUI 2011AB)
CL Item
Yes - registration not required according to protocol 7.1 (2)
yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
Consistent with (Code-2)
C0332290 (UMLS CUI 2011AB)
385433004 (SNOMEDCT_2012_01_31)
Protocol (Code-3)
C2348563 (UMLS CUI 2011AB)
SAE (Code-4)
C1519255 (UMLS CUI 2011AB)
Registration (Code-5)
C1514821 (UMLS CUI 2011AB)
not (Code-6)
C1518422 (UMLS CUI 2011AB)
Item
Activities regarding investigational drug
integer
Activities (Code-1)
C0441655 (UMLS CUI 2011AB)
257733005 (SNOMEDCT_2012_01_31)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
Related (Code-2)
C0699792 (UMLS CUI 2011AB)
263498003 (SNOMEDCT_2012_01_31)
Investigational Drug (Code-3)
C0013230 (UMLS CUI 2011AB)
Maßnahmen bzgl. Prüfmedikation
Code List
Activities regarding investigational drug
CL Item
Absent (0)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
CL Item
Medication dose changed (1)
C1608430 (UMLS CUI 2011AB)
10064926 (MedDRA 14.1)
CL Item
Drug temporarily discontinued (2)
Medication (Code-1)
C0013227 (UMLS CUI 2011AB)
MTHU038481 (LOINC Version 232)
Temporary (Code-2)
C0205374 (UMLS CUI 2011AB)
14803004 (SNOMEDCT_2012_01_31)
Discontinued (Code-3)
C1444662 (UMLS CUI 2011AB)
410546004 (SNOMEDCT_2012_01_31)
CL Item
Drug permanent discontinued (3)
Medication (Code-1)
C0013227 (UMLS CUI 2011AB)
MTHU038481 (LOINC Version 232)
permanent (Code-2)
C0205355 (UMLS CUI 2011AB)
6934004 (SNOMEDCT_2012_01_31)
Discontinued (Code-3)
C1444662 (UMLS CUI 2011AB)
410546004 (SNOMEDCT_2012_01_31)
AE führt zum Studienabbruch
Item
Adverse Event Caused Study Discontinuation
boolean
C2826233 (UMLS CUI 2011AB)
Item
Relationship with investigational drug
integer
Relationship (Code-1)
C0699792 (UMLS CUI 2011AB)
263498003 (SNOMEDCT_2012_01_31)
Investigational Drug (Code-2)
C0013230 (UMLS CUI 2011AB)
Zusammenhang mit Prüfmedikation
Code List
Relationship with investigational drug
CL Item
No suspected relationship with investigational drug (0)
Absent (Code-1)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
Suspected (Code-2)
C0750491 (UMLS CUI 2011AB)
415684004 (SNOMEDCT_2012_01_31)
Relationship (Code-3)
C0699792 (UMLS CUI 2011AB)
263498003 (SNOMEDCT_2012_01_31)
Investigational Drug (Code-4)
C0013230 (UMLS CUI 2011AB)
CL Item
Suspected relationship with investigational drug (1)
Suspected (Code-1)
C0750491 (UMLS CUI 2011AB)
415684004 (SNOMEDCT_2012_01_31)
Relationship (Code-2)
C0699792 (UMLS CUI 2011AB)
263498003 (SNOMEDCT_2012_01_31)
Investigational Drug (Code-3)
C0013230 (UMLS CUI 2011AB)
Item
CTCAE grading 1-5
integer
CTCAE (Code-1)
C1516728 (UMLS CUI 2011AB)
CTCAE-Grading
Code List
CTCAE grading 1-5
CL Item
CTCAE Grade 1 (1)
C1513302 (UMLS CUI 2011AB)
CL Item
CTCAE Grade 2 (2)
C1513374 (UMLS CUI 2011AB)
CL Item
CTCAE Grade 3 (3)
C1519275 (UMLS CUI 2011AB)
CL Item
CTCAE Grade 4 (4)
CL427997 (UMLS CUI 2011AB)
CL Item
CTCAE Grade 5 (5)
C1705232 (UMLS CUI 2011AB)
Item Group
End AE - Documentation of tracing: - up to 30 days after study termination/discontinuation - not required in case of later new occurrences of AEs
End date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Ende Datum
Item
End date
date
End date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
[oder] anhaltend (anhaltend bei Ende der Dokum.-pflicht)
Item
[or] ongoing (ongoing at end of documentation task)
integer
Continue (Code-1)
C0750536 (UMLS CUI 2011AB)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Item
Outcome of AE 0-5
integer
Outcome (Code-1)
C1274040 (UMLS CUI 2011AB)
394617004 (SNOMEDCT_2012_01_31)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Ausgang des AE
Code List
Outcome of AE 0-5
CL Item
Recovered (0)
Recovered or Resolved (Code-1)
C1709863 (UMLS CUI 2011AB)
CL Item
Better (1)
C0332272 (UMLS CUI 2011AB)
3442003 (SNOMEDCT_2012_01_31)
CL Item
Not recovered (2)
Not Recovered or Not Resolved (Code-1)
C1709277 (UMLS CUI 2011AB)
CL Item
Recovered with defect (3)
Recovered or Resolved with Sequelae (Code-1)
C1709862 (UMLS CUI 2011AB)
CL Item
unknown (4)
C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)
CL Item
Death (5)
C1306577 (UMLS CUI 2011AB)
397709008 (SNOMEDCT_2012_01_31)
10011906 (MedDRA 14.1)
Item Group
Signature
C1519316 (UMLS CUI 2011AB)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Name/Unterschrift Prüfarzt
Item
Name/Signature study physician
string
Name (Code-1)
C0027365 (UMLS CUI 2011AB)
MTHU008539 (LOINC Version 232)
Signature (Code-2)
C1519316 (UMLS CUI 2011AB)
Study (Code-3)
C0008976 (UMLS CUI 2011AB)
110465008 (SNOMEDCT_2012_01_31)
Physician (Code-4)
C0031831 (UMLS CUI 2011AB)
309343006 (SNOMEDCT_2012_01_31)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
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