ID

6422

Description

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

Keywords

Versions (2)
  1. 11/2/13 11/2/13 -
  2. 12/22/14 12/22/14 - Martin Dugas
Uploaded on

December 22, 2014

DOI

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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

German English

Studienende / Studienabbruch

1 forms  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Studienende / Studienabbruch
Study end
Description

Study end

Alias
Code-1
Study end
UMLS CUI-1
C2983670
Pat. No.: -
Description

Pat.-Nr.

Data type

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Regular study end on:
Description

Regular study end

Data type

date

Alias
Code-1
Regular
UMLS CUI 2011AB
C0205272
SNOMEDCT_2012_01_31
17854005
Code-2
Study end
UMLS CUI 2011AB
C2983670
If 5-Azacytidine was administered, please specify date of last dose:
Description

Last dose of 5-Azacytidine

Data type

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
Early Termination of Clinical Trials
Description

Early Termination of Clinical Trials

Alias
UMLS CUI 2011AB
C2718058
Early termination of clinical trial on:
Description

Early termination of clinical trial

Data type

date

Alias
Code-1
Early termination of clinical trial
UMLS CUI 2011AB
C2718058
Reason:
Description

Reason

Data type

integer

Alias
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Other reason:
Description

Other reason

Data type

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-No:
Description

AE-No

Data type

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
Remission status at date of study termination:
Description

Remission status at date of study termination

Data type

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
Signature
Description

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Description

Datum

Data type

date

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

Name/Unterschrift Prüfarzt

Data type

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 forms
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Studienende / Studienabbruch
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study end
Study end (Code-1)
C2983670 (UMLS CUI-1)
Pat.-Nr.
Item
Pat. No.: -
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Regular study end
Item
Regular study end on:
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
If 5-Azacytidine was administered, please specify date of last dose:
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
Early Termination of Clinical Trials
C2718058 (UMLS CUI 2011AB)
Early termination of clinical trial
Item
Early termination of clinical trial on:
date
Early termination of clinical trial (Code-1)
C2718058 (UMLS CUI 2011AB)
Item
Reason:
integer
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Reason
Code List
Reason:
CL Item
Did not meet inclusion criterion (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
Exclusion criterion present (Exclusion Criterion)
Exclusion Criterion (Code-1)
CL425201 (UMLS CUI 2011AB)
Present (Code-2)
C0150312 (UMLS CUI 2011AB)
52101004 (SNOMEDCT_2012_01_31)
CL Item
Adverse event(s) (Please fill out AE form and, if necessary, SAE form!)  (Adverse event(s))
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
CL Item
Primary therapy failure (Primary therapy failure)
primary (Code-1)
CL414904 (UMLS CUI 2011AB)
Treatment failure (Code-2)
C0162643 (UMLS CUI 2011AB)
10066901 (MedDRA 14.1)
CL Item
Relapse (Please fill out form "Reizidiv" page 83+84!) (Relapse)
C0035020 (UMLS CUI 2011AB)
263855007 (SNOMEDCT_2012_01_31)
CL Item
Death (Please fill out form "Tod" page 85!) (Death)
C0011065 (UMLS CUI 2011AB)
419620001 (SNOMEDCT_2012_01_31)
E11080 (CTCAE 1105E)
CL Item
Consent withdrawn (Consent withdrawn)
C1707492 (UMLS CUI 2011AB)
CL Item
Other reason: (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
Other reason:
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-No:
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
Remission status at date of study termination:
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
Remission status at date of study termination:
CL Item
CR or morphologic leukemia-free 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
Primary therapy failure / Relapse (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
unknown (3)
C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)
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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