ID

6422

Descripción

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

Palabras clave

Versiones (2)
  1. 2/11/13 2/11/13 -
  2. 22/12/14 22/12/14 - Martin Dugas
Subido en

22 de diciembre de 2014

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Studienende / Studienabbruch EudraCT 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3

Alemán Inglés

Studienende / Studienabbruch

1 formularios  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Studienende / Studienabbruch
Studienende
Descripción

Studienende

Alias
Code-1
Study end
UMLS CUI-1
C2983670
Pat.-Nr.: -
Descripción

Pat.-Nr.

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Reguläres Studienende am:
Descripción

Regular study end

Tipo de datos

date

Alias
Code-1
Regular
UMLS CUI 2011AB
C0205272
SNOMEDCT_2012_01_31
17854005
Code-2
Study end
UMLS CUI 2011AB
C2983670
Sofern 5-Azacytidin verabreicht wurde, bitte Datum der letzten Gabe angeben:
Descripción

Last dose of 5-Azacytidine

Tipo de datos

date

Alias
Code-1
5-Azacytidin
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
88551000
Code-2
Date last dose
UMLS CUI 2011AB
C1762893
LOINC Version 232
MTHU014073
Vorzeitiger Studienabbruch
Descripción

Vorzeitiger Studienabbruch

Alias
UMLS CUI 2011AB
C2718058
Vorzeitiger Studienabbruch am:
Descripción

Early termination of clinical trial

Tipo de datos

date

Alias
Code-1
Early termination of clinical trial
UMLS CUI 2011AB
C2718058
Grund:
Descripción

Reason

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Anderer Grund:
Descripción

Other reason

Tipo de datos

string

Alias
Code-1
Other
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
Reason
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-3
Free Text Format
UMLS CUI 2011AB
C2348713
AE-Nr:
Descripción

AE-No

Tipo de datos

integer

Alias
Code-1
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
Code-2
Number
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
Remissionsstatus zum Zeitpunkt des Studienabbruchs:
Descripción

Remission status at date of study termination

Tipo de datos

integer

Alias
Code-1
Remission
UMLS CUI 2011AB
C0544452
SNOMEDCT_2012_01_31
277022003
Code-2
Status
UMLS CUI 2011AB
C0449438
SNOMEDCT_2012_01_31
263490005
LOINC Version 232
MTHU015827
Code-3
Date
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-4
Study Terminated
UMLS CUI 2011AB
C2348570
Unterschrift
Descripción

Unterschrift

Alias
UMLS CUI 2011AB
C1519316
Datum:
Descripción

Datum

Tipo de datos

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Name/Unterschrift Prüfarzt
Descripción

Name/Unterschrift Prüfarzt

Tipo de datos

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

Studienende / Studienabbruch

1 formularios
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Studienende / Studienabbruch
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Studienende
Study end (Code-1)
C2983670 (UMLS CUI-1)
Pat.-Nr.
Item
Pat.-Nr.: -
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Regular study end
Item
Reguläres Studienende am:
date
Regular (Code-1)
C0205272 (UMLS CUI 2011AB)
17854005 (SNOMEDCT_2012_01_31)
Study end (Code-2)
C2983670 (UMLS CUI 2011AB)
Last dose of 5-Azacytidine
Item
Sofern 5-Azacytidin verabreicht wurde, bitte Datum der letzten Gabe angeben:
date
5-Azacytidin (Code-1)
C0004475 (UMLS CUI 2011AB)
88551000 (SNOMEDCT_2012_01_31)
Date last dose (Code-2)
C1762893 (UMLS CUI 2011AB)
MTHU014073 (LOINC Version 232)
Item Group
Vorzeitiger Studienabbruch
C2718058 (UMLS CUI 2011AB)
Early termination of clinical trial
Item
Vorzeitiger Studienabbruch am:
date
Early termination of clinical trial (Code-1)
C2718058 (UMLS CUI 2011AB)
Item
Grund:
integer
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Reason
Code List
Grund:
CL Item
Einschlusskriterium nicht erfüllt (Did not meet inclusion criterion)
Inclusion Criterion (Code-1)
CL425202 (UMLS CUI 2011AB)
not (Code-2)
C1518422 (UMLS CUI 2011AB)
Meet (Code-3)
C1550543 (UMLS CUI 2011AB)
FLFS (HL7 V3 2006_05)
CL Item
Ausschlusskriterium liegt vor (Exclusion Criterion)
Exclusion Criterion (Code-1)
CL425201 (UMLS CUI 2011AB)
Present (Code-2)
C0150312 (UMLS CUI 2011AB)
52101004 (SNOMEDCT_2012_01_31)
CL Item
Unerwünschte(s) Ereignis(se) (Bitte AE- und ggf. SAE-Bogen ausfüllen!)  (Adverse event(s))
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
CL Item
Primäres Therapieversagen (Primary therapy failure)
primary (Code-1)
CL414904 (UMLS CUI 2011AB)
Treatment failure (Code-2)
C0162643 (UMLS CUI 2011AB)
10066901 (MedDRA 14.1)
CL Item
Rezidiv (Bitte Bogen "Rezidiv" Seite 83+84 ausfüllen!) (Relapse)
C0035020 (UMLS CUI 2011AB)
263855007 (SNOMEDCT_2012_01_31)
CL Item
Tod (Bitte Bogen "Tod" Seite 85 ausfüllen!) (Death)
C0011065 (UMLS CUI 2011AB)
419620001 (SNOMEDCT_2012_01_31)
E11080 (CTCAE 1105E)
CL Item
Einverständnis entzogen (Consent withdrawn)
C1707492 (UMLS CUI 2011AB)
CL Item
Anderer Grund: (Other reason)
Other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Reason (Code-2)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Other reason
Item
Anderer Grund:
string
Other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Reason (Code-2)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Free Text Format (Code-3)
C2348713 (UMLS CUI 2011AB)
AE-No
Item
AE-Nr:
integer
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Number (Code-2)
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
Item
Remissionsstatus zum Zeitpunkt des Studienabbruchs:
integer
Remission (Code-1)
C0544452 (UMLS CUI 2011AB)
277022003 (SNOMEDCT_2012_01_31)
Status (Code-2)
C0449438 (UMLS CUI 2011AB)
263490005 (SNOMEDCT_2012_01_31)
MTHU015827 (LOINC Version 232)
Date (Code-3)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Study Terminated (Code-4)
C2348570 (UMLS CUI 2011AB)
Remission status at date of study termination
Code List
Remissionsstatus zum Zeitpunkt des Studienabbruchs:
CL Item
CR oder morphologisch Leukämie-freier Status (1)
CR (Code-1)
C0677874 (UMLS CUI 2011AB)
103338009 (SNOMEDCT_2012_01_31)
Morphology (Code-2)
C0332437 (UMLS CUI 2011AB)
116676008 (SNOMEDCT_2012_01_31)
MTHU008051 (LOINC Version 232)
leukemia (Code-3)
C0023418 (UMLS CUI 2011AB)
93143009 (SNOMEDCT_2012_01_31)
10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
Free (Code-4)
C0332296 (UMLS CUI 2011AB)
37837009 (SNOMEDCT_2012_01_31)
Status (Code-5)
C0449438 (UMLS CUI 2011AB)
263490005 (SNOMEDCT_2012_01_31)
MTHU015827 (LOINC Version 232)
CL Item
Primäres Therapieversagen / Rezidiv (2)
primary (Code-1)
CL414904 (UMLS CUI 2011AB)
Treatment failure (Code-2)
C0162643 (UMLS CUI 2011AB)
10066901 (MedDRA 14.1)
Relapse (Code-3)
C0035020 (UMLS CUI 2011AB)
263855007 (SNOMEDCT_2012_01_31)
CL Item
unbekannt (3)
C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)
Item Group
Unterschrift
C1519316 (UMLS CUI 2011AB)
Datum
Item
Datum:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Name/Unterschrift Prüfarzt
Item
Name/Unterschrift Prüfarzt
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)
Volver a la parte superior de la página 

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