ID

43301

Description

AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years http://clinicaltrials.gov/show/NCT00180102 Prospektive, randomisierte, multizentrische Therapieoptimierungsstudie - Studienprotokoll AML2003

Link

http://clinicaltrials.gov/show/NCT00180102

Keywords

Versions (3)
  1. 7/30/13 7/30/13 - Martin Dugas
  2. 8/26/15 8/26/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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1. Induction Acute Myeloid Leukemia <=60 years (AML2003) NCT00180102

German English

1. Induction Acute Myeloid Leukemia <=60 years (AML2003) NCT00180102

1 forms  
Allgemeine Angaben
Description

Allgemeine Angaben

Alias
SNOMEDCT_2012_01_31
106227002
UMLS CUI-1
C1508263
Klinik-Nr.:
Description

Klinik-Nr.

Data type

integer

Alias
UMLS CUI 2011AB
C0442592
SNOMEDCT_2012_01_31
257585005
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
410680006
LOINC Version 232
MTHU024869
Patienten-Nr.: 2-
Description

Patienten-Nr.

Data type

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Patienten-Initialen: (Nachname/Vorname)
Description

Patienten-Initialen

Data type

string

Alias
UMLS CUI 2011AB
C0030705
SNOMEDCT_2012_01_31
116154003
UMLS CUI 2011AB
C1555582
HL7 V3 2006_05
IN
UMLS CUI 2011AB
C1301584
SNOMEDCT_2012_01_31
397678008
LOINC Version 232
MTHU020554
UMLS CUI 2011AB
C1443235
SNOMEDCT_2012_01_31
408677003
LOINC Version 232
MTHU020551
Beginn:
Description

Beginn

Data type

date

Alias
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Ende:
Description

Ende

Data type

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Größe
Description

Height

Data type

float

Measurement units
  • cm
Alias
SNOMEDCT_2012_01_31
246115007
LOINC Version 232
MTHU010347
SNOMEDCT_2012_01_31
258672001
UMLS CUI [1]
C0005890
cm
Gewicht
Description

Weight

Data type

float

Measurement units
  • kg
Alias
SNOMEDCT_2012_01_31
272102008
LOINC Version 232
MTHU021563
SNOMEDCT_2012_01_31
258683005
UMLS CUI [1]
C0005910
kg
Körperoberfläche
Description

BSA

Data type

float

Measurement units
  • m²
Alias
SNOMEDCT_2012_01_31
301898006
MedDRA 14.1
10050311
SNOMEDCT_2012_01_31
278077005
UMLS CUI [1]
C0005902
m²
Daunorubicin
Description

Daunorubicin

Alias
UMLS CUI 2011AB
C0011015
SNOMEDCT_2012_01_31
372715008
Tag - tatsächlich (vorgesehen 3-5)
Description

Day - actual

Data type

string

Alias
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AB
C0237400
Daunorubicin Tagesdosis - tatsächlich (vorgesehen 60 mg/qm über 2h i.v.)
Description

Daily dose - actual

Data type

string

Alias
UMLS CUI 2011AB
C2348070
UMLS CUI 2011AB
C0237400
Gesamtdosis absolut
Description

Total dose absolute

Data type

float

Measurement units
  • mg
Alias
SNOMEDCT_2012_01_31
56136002
SNOMEDCT_2012_01_31
258684004
UMLS CUI [1]
C2986497
mg
Dosisreduktion
Description

Dosisreduktion

Data type

boolean

Alias
UMLS CUI 2011AB
C1707814
Ara-C
Description

Ara-C

Alias
UMLS CUI 2011AB
C0010711
SNOMEDCT_2012_01_31
89265009
Tag - tatsächlich (vorgesehen 1-7)
Description

Day - actual

Data type

string

Alias
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AB
C0237400
Ara-C Tagesdosis - tatsächlich (vorgesehen 100 mg/qm über 24h i.v.)
Description

Daily dose - actual

Data type

string

Alias
UMLS CUI 2011AB
C2348070
UMLS CUI 2011AB
C0237400
Gesamtdosis absolut
Description

Total dose absolute

Data type

float

Measurement units
  • mg
Alias
SNOMEDCT_2012_01_31
56136002
SNOMEDCT_2012_01_31
258684004
UMLS CUI [1]
C2986497
mg
Dosisreduktion
Description

Dosis reduction

Data type

boolean

Alias
UMLS CUI [1]
C1707814
G-CSF-Gabe:
Description

G-CSF-Gabe:

Alias
UMLS CUI 2011AB
C0079459
SNOMEDCT_2012_01_31
80572003
LOINC Version 232
MTHU031847
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Beginn:
Description

begin

Data type

date

Alias
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Ende:
Description

end

Data type

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Handelsname:
Description

Proprietary Name

Data type

string

Alias
UMLS CUI 2011AB
C0592503
Gesamtdosis
Description

Total dose

Data type

float

Measurement units
  • µg
Alias
SNOMEDCT_2012_01_31
258685003
UMLS CUI [1]
C2986497
µg
Zytopeniedauer
Description

Zytopeniedauer

Alias
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
SNOMEDCT_2012_01_31
103335007
LOINC Version 232
MTHU001938
UMLS CUI-1
C0010828
UMLS CUI-2
C0449238
Beginn Leukozyten <1,0 GPt/l bzw. <1000 /ul:
Description

start leukopenia

Data type

date

Alias
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
UMLS CUI 2011AB
C0023516
SNOMEDCT_2012_01_31
52501007
MedDRA 14.1
10047955
LOINC Version 232
MTHU001946
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Ende (3x Leukozyten >1,0 GPt/l bzw. >=1000 /ul):
Description

end leukpenia

Data type

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Zytopenie andauernd
Description

Ongoing cytopenia

Data type

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0549178
Beginn Neutrophile <0,5 GPt/l bzw. <500 /ul:
Description

start neutropenia

Data type

date

Alias
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Ende (3x Neutrophile >0,5 GPt/l bzw. >=500 /ul):
Description

end neutropenia

Data type

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Zytopenie andauernd
Description

Zytopenie andauernd

Data type

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0549178
Beginn Thrombozyten <20 GPt/l bzw. <20000 /ul:
Description

start thrombopenia

Data type

date

Alias
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Ende (3x Thrombozyten >20 GPt/l bzw. >=20000 /ul):
Description

end thrombopenia

Data type

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Zytopenie andauernd
Description

Zytopenie andauernd

Data type

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0549178
Transfusionen
Description

Transfusionen

Alias
UMLS CUI-1
C1879316
Anzahl Erythrozyten-Transfusionen
Description

Number of erythrocyte transfusions

Data type

integer

Alias
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
andauernde Erythrozyten-Transfusionen
Description

ongoing erythrocyte transfusions

Data type

boolean

Alias
UMLS CUI 2011AB
C0549178
Anzahl Thrombozyten-Transfusionen (Einzelspender)
Description

platelets single donors

Data type

integer

Alias
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
andauernde Thrombozyten-Transfusionen
Description

ongoing thrombocyte transfusions

Data type

boolean

Alias
UMLS CUI 2011AB
C0549178
Anzahl Thrombozyten-Transfusionen (gepoolt)
Description

platelets pooled

Data type

integer

Alias
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
andauernde Thrombozyten-Transfusionen
Description

ongoing thrombocyte transfusions

Data type

boolean

Alias
UMLS CUI 2011AB
C0549178
Unterschrift
Description

Unterschrift

Alias
UMLS CUI-1
C1519316
Datum
Description

Datum

Data type

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Name des Studienarztes/Unterschrift
Description

Name des Studienarztes/Unterschrift

Data type

string

Alias
UMLS CUI 2011AB
C0027365
LOINC Version 232
MTHU008539
UMLS CUI 2011AB
C0008976
SNOMEDCT_2012_01_31
110465008
UMLS CUI 2011AB
C0031831
SNOMEDCT_2012_01_31
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
UMLS CUI 2011AB
C1519316
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Similar models

1. Induction Acute Myeloid Leukemia <=60 years (AML2003) NCT00180102

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Allgemeine Angaben
106227002 (SNOMEDCT_2012_01_31)
C1508263 (UMLS CUI-1)
Klinik-Nr.
Item
Klinik-Nr.:
integer
C0442592 (UMLS CUI 2011AB)
257585005 (SNOMEDCT_2012_01_31)
C0237753 (UMLS CUI 2011AB)
410680006 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
Patienten-Nr.
Item
Patienten-Nr.: 2-
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Patienten-Initialen
Item
Patienten-Initialen: (Nachname/Vorname)
string
C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
C1555582 (UMLS CUI 2011AB)
IN (HL7 V3 2006_05)
C1301584 (UMLS CUI 2011AB)
397678008 (SNOMEDCT_2012_01_31)
MTHU020554 (LOINC Version 232)
C1443235 (UMLS CUI 2011AB)
408677003 (SNOMEDCT_2012_01_31)
MTHU020551 (LOINC Version 232)
Beginn
Item
Beginn:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Ende
Item
Ende:
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Height
Item
Größe
float
246115007 (SNOMEDCT_2012_01_31)
MTHU010347 (LOINC Version 232)
258672001 (SNOMEDCT_2012_01_31)
C0005890 (UMLS CUI [1])
Weight
Item
Gewicht
float
272102008 (SNOMEDCT_2012_01_31)
MTHU021563 (LOINC Version 232)
258683005 (SNOMEDCT_2012_01_31)
C0005910 (UMLS CUI [1])
BSA
Item
Körperoberfläche
float
301898006 (SNOMEDCT_2012_01_31)
10050311 (MedDRA 14.1)
278077005 (SNOMEDCT_2012_01_31)
C0005902 (UMLS CUI [1])
Item Group
Daunorubicin
C0011015 (UMLS CUI 2011AB)
372715008 (SNOMEDCT_2012_01_31)
Day - actual
Item
Tag - tatsächlich (vorgesehen 3-5)
string
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
D (HL7 V3 2006_05)
C0237400 (UMLS CUI 2011AB)
Daily dose - actual
Item
Daunorubicin Tagesdosis - tatsächlich (vorgesehen 60 mg/qm über 2h i.v.)
string
C2348070 (UMLS CUI 2011AB)
C0237400 (UMLS CUI 2011AB)
Total dose absolute
Item
Gesamtdosis absolut
float
56136002 (SNOMEDCT_2012_01_31)
258684004 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI [1])
Dosisreduktion
Item
Dosisreduktion
boolean
C1707814 (UMLS CUI 2011AB)
Item Group
Ara-C
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Day - actual
Item
Tag - tatsächlich (vorgesehen 1-7)
string
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
D (HL7 V3 2006_05)
C0237400 (UMLS CUI 2011AB)
Daily dose - actual
Item
Ara-C Tagesdosis - tatsächlich (vorgesehen 100 mg/qm über 24h i.v.)
string
C2348070 (UMLS CUI 2011AB)
C0237400 (UMLS CUI 2011AB)
Total dose absolute
Item
Gesamtdosis absolut
float
56136002 (SNOMEDCT_2012_01_31)
258684004 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI [1])
Dosis reduction
Item
Dosisreduktion
boolean
C1707814 (UMLS CUI [1])
Item Group
G-CSF-Gabe:
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
begin
Item
Beginn:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
end
Item
Ende:
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Proprietary Name
Item
Handelsname:
string
C0592503 (UMLS CUI 2011AB)
Total dose
Item
Gesamtdosis
float
258685003 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI [1])
Item Group
Zytopeniedauer
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
103335007 (SNOMEDCT_2012_01_31)
MTHU001938 (LOINC Version 232)
C0010828 (UMLS CUI-1)
C0449238 (UMLS CUI-2)
start leukopenia
Item
Beginn Leukozyten <1,0 GPt/l bzw. <1000 /ul:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
C0023516 (UMLS CUI 2011AB)
52501007 (SNOMEDCT_2012_01_31)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
end leukpenia
Item
Ende (3x Leukozyten >1,0 GPt/l bzw. >=1000 /ul):
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
Ongoing cytopenia
Item
Zytopenie andauernd
boolean
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
C0549178 (UMLS CUI 2011AB)
start neutropenia
Item
Beginn Neutrophile <0,5 GPt/l bzw. <500 /ul:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
end neutropenia
Item
Ende (3x Neutrophile >0,5 GPt/l bzw. >=500 /ul):
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
Zytopenie andauernd
Item
Zytopenie andauernd
boolean
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
C0549178 (UMLS CUI 2011AB)
start thrombopenia
Item
Beginn Thrombozyten <20 GPt/l bzw. <20000 /ul:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
end thrombopenia
Item
Ende (3x Thrombozyten >20 GPt/l bzw. >=20000 /ul):
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
Zytopenie andauernd
Item
Zytopenie andauernd
boolean
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
C0549178 (UMLS CUI 2011AB)
Item Group
Transfusionen
C1879316 (UMLS CUI-1)
Number of erythrocyte transfusions
Item
Anzahl Erythrozyten-Transfusionen
integer
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
ongoing erythrocyte transfusions
Item
andauernde Erythrozyten-Transfusionen
boolean
C0549178 (UMLS CUI 2011AB)
platelets single donors
Item
Anzahl Thrombozyten-Transfusionen (Einzelspender)
integer
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
ongoing thrombocyte transfusions
Item
andauernde Thrombozyten-Transfusionen
boolean
C0549178 (UMLS CUI 2011AB)
platelets pooled
Item
Anzahl Thrombozyten-Transfusionen (gepoolt)
integer
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
ongoing thrombocyte transfusions
Item
andauernde Thrombozyten-Transfusionen
boolean
C0549178 (UMLS CUI 2011AB)
Item Group
Unterschrift
C1519316 (UMLS CUI-1)
Datum
Item
Datum
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Name des Studienarztes/Unterschrift
Item
Name des Studienarztes/Unterschrift
string
C0027365 (UMLS CUI 2011AB)
MTHU008539 (LOINC Version 232)
C0008976 (UMLS CUI 2011AB)
110465008 (SNOMEDCT_2012_01_31)
C0031831 (UMLS CUI 2011AB)
309343006 (SNOMEDCT_2012_01_31)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C1519316 (UMLS CUI 2011AB)
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