ID
42872
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)
- 16-12-13 16-12-13 -
- 17-09-21 17-09-21 -
Geüploaded op
17 september 2021
DOI
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Licentie
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
Unerwünschtes Ereignis (AE) - Blatt Nr.: 1
- StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
Beschrijving
Unerwünschtes Ereignis (AE)
Alias
- Code-1
- Adverse event
- UMLS CUI 2011AB
- C0877248
- MedDRA 14.1
- 10060933
- LOINC Version 232
- MTHU014542
Beschrijving
fortlaufende AE-Nr.
Datatype
integer
Alias
- Code-1
- ongoing
- UMLS CUI 2011AB
- C0549178
- 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
Beschrijving
Unerwünschtes Ereignis (AE)
Datatype
string
Alias
- Code-1
- Adverse event
- UMLS CUI 2011AB
- C0877248
- MedDRA 14.1
- 10060933
- LOINC Version 232
- MTHU014542
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
Beschrijving
Schwerwiegend
Datatype
integer
Alias
- Code-1
- Serious
- UMLS CUI 2011AB
- C0205404
- SNOMEDCT_2012_01_31
- 42745003
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
Beschrijving
AE führt zum Studienabbruch
Datatype
boolean
Alias
- UMLS CUI 2011AB
- C2826233
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
Beschrijving
CTCAE-Grading
Datatype
integer
Alias
- Code-1
- CTCAE
- UMLS CUI 2011AB
- C1516728
Beschrijving
Ende AE - Dokumentation der Nachverfolgung: - bis 30 Tage nach Studienende/-abbruch - bei später neu aufgetretenen AEs nicht erforderlich
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
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
Beschrijving
[oder] anhaltend (anhaltend bei Ende der Dokum.-pflicht)
Datatype
integer
Alias
- Code-1
- Continue
- UMLS CUI 2011AB
- C0549178
- Code-2
- Adverse event
- UMLS CUI 2011AB
- C0877248
- MedDRA 14.1
- 10060933
- LOINC Version 232
- MTHU014542
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
Beschrijving
Unterschrift
Alias
- UMLS CUI 2011AB
- C1519316
Beschrijving
Datum
Datatype
date
Alias
- UMLS CUI 2011AB
- C0011008
- SNOMEDCT_2012_01_31
- 410671006
- LOINC Version 232
- MTHU021546
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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Unerwünschtes Ereignis (AE) - Blatt Nr.: 1
- StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
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Adverse event (Code-2)
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Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
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Serious Adverse Event (Code-2)
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registered (Code-3)
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Consistent with (Code-2)
C0332290 (UMLS CUI 2011AB)
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Protocol (Code-3)
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SAE (Code-4)
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Registration (Code-5)
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not (Code-6)
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C0441655 (UMLS CUI 2011AB)
257733005 (SNOMEDCT_2012_01_31)
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Investigational Drug (Code-3)
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2667000 (SNOMEDCT_2012_01_31)
10064926 (MedDRA 14.1)
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)
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)
C0699792 (UMLS CUI 2011AB)
263498003 (SNOMEDCT_2012_01_31)
Investigational Drug (Code-2)
C0013230 (UMLS CUI 2011AB)
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)
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)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
C0549178 (UMLS CUI 2011AB)
Adverse event (Code-2)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
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)
C1709863 (UMLS CUI 2011AB)
3442003 (SNOMEDCT_2012_01_31)
C1709277 (UMLS CUI 2011AB)
C1709862 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)
397709008 (SNOMEDCT_2012_01_31)
10011906 (MedDRA 14.1)
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)
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C0031831 (UMLS CUI 2011AB)
309343006 (SNOMEDCT_2012_01_31)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)