ID

4048

Description

Prospektive, randomisierte, multizentrische Therapieoptimierungsstudie - Studienprotokoll AML2003 http://clinicaltrials.gov/show/NCT00180102

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

July 30, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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1. Induktionstherapie (DA) CRF AML2003 AML

German English

1. Induktionstherapie (DA)

1 forms  
General information
Description

General information

Alias
UMLS CUI 2011AB
C0332118
SNOMEDCT_2012_01_31
106227002
Clinic no.:
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
Patient No.: 2-
Description

Patienten-Nr.

Data type

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Patient initials: (Last name/Forename)
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
Start date:
Description

Beginn

Data type

date

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

Ende

Data type

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Size[cm]:
Description

Größe

Data type

integer

Alias
UMLS CUI 2011AB
C0456389
SNOMEDCT_2012_01_31
246115007
LOINC Version 232
MTHU010347
UMLS CUI 2011AB
C0475210
SNOMEDCT_2012_01_31
258672001
Weight [kg]:
Description

Gewicht

Data type

integer

Alias
UMLS CUI 2011AB
C0043100
SNOMEDCT_2012_01_31
272102008
LOINC Version 232
MTHU021563
UMLS CUI 2011AB
C0439209
SNOMEDCT_2012_01_31
258683005
Body Surface Area [sqm]:
Description

Körperoberfläche

Data type

float

Alias
UMLS CUI 2011AB
C0005902
SNOMEDCT_2012_01_31
301898006
MedDRA 14.1
10050311
UMLS CUI 2011AB
C0457242
SNOMEDCT_2012_01_31
278077005
Daunorubicin
Description

Daunorubicin

Alias
UMLS CUI 2011AB
C0011015
SNOMEDCT_2012_01_31
372715008
Day - actual (scheduled 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 daily dose - actual (scheduled 60 mg/sqm intravenous for 2 h)
Description

Daily dose - actual

Data type

string

Alias
UMLS CUI 2011AB
C2348070
UMLS CUI 2011AB
C0237400
Absolute total dose (mg)
Description

Gesamtdosis absolut (mg)

Data type

float

Alias
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
UMLS CUI 2011AB
C2986497
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Dose Reduced
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
Day - actual (scheduled 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 Daily dose - actual (scheduled 100 mg/sqm intravenous for 24 h)
Description

Daily dose - actual

Data type

string

Alias
UMLS CUI 2011AB
C2348070
UMLS CUI 2011AB
C0237400
Absolute total dose (mg)
Description

Gesamtdosis absolut (mg)

Data type

float

Alias
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
UMLS CUI 2011AB
C2986497
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Dose Reduced
Description

Dosisreduktion

Data type

boolean

Alias
UMLS CUI 2011AB
C1707814
G-CSF dose:
Description

G-CSF dose:

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

begin

Data type

date

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

end

Data type

date

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

Proprietary Name

Data type

string

Alias
UMLS CUI 2011AB
C0592503
Total Dose [ug]:
Description

Total dose

Data type

float

Alias
UMLS CUI 2011AB
C2986497
UMLS CUI 2011AB
C0439211
SNOMEDCT_2012_01_31
258685003
Cytopenia duration:
Description

Cytopenia duration:

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0449238
SNOMEDCT_2012_01_31
103335007
LOINC Version 232
MTHU001938
Start date leucocytes <1,0 GPt/l or <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
End date (3x leucocytes >1,0 GPt/l or >=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
Ongoing cytopenia
Description

Ongoing cytopenia

Data type

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0750536
Start date neutrophils <0,5 GPt/l or <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
End date (3x neutrophils >0,5 GPt/l or >=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
Ongoing cytopenia
Description

Zytopenie andauernd

Data type

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0750536
Start date platelets <20 GPt/l or <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
End date (3x platelets>20 GPt/l or >=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
Ongoing cytopenia
Description

Zytopenie andauernd

Data type

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0750536
Transfusions:
Description

Transfusions:

Number of erythrocyte transfusions
Description

Number of erythrocyte transfusions

Data type

integer

Alias
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
ongoing erythrocyte transfusions
Description

ongoing erythrocyte transfusions

Data type

boolean

Alias
UMLS CUI 2011AB
C0750536
Number of platelet transfusions (single donors)
Description

platelets single donors

Data type

integer

Alias
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
ongoing thrombocyte transfusions
Description

ongoing thrombocyte transfusions

Data type

boolean

Alias
UMLS CUI 2011AB
C0750536
Number of platelet transfusions (pooled donors)
Description

platelets pooled

Data type

integer

Alias
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
ongoing thrombocyte transfusions
Description

ongoing thrombocyte transfusions

Data type

boolean

Alias
UMLS CUI 2011AB
C0750536
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 of study physician/Signature
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. Induktionstherapie (DA)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
C0332118 (UMLS CUI 2011AB)
106227002 (SNOMEDCT_2012_01_31)
Klinik-Nr.
Item
Clinic no.:
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
Patient No.: 2-
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Patienten-Initialen
Item
Patient initials: (Last name/Forename)
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
Start date:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Ende
Item
End date:
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Größe
Item
Size[cm]:
integer
C0456389 (UMLS CUI 2011AB)
246115007 (SNOMEDCT_2012_01_31)
MTHU010347 (LOINC Version 232)
C0475210 (UMLS CUI 2011AB)
258672001 (SNOMEDCT_2012_01_31)
Gewicht
Item
Weight [kg]:
integer
C0043100 (UMLS CUI 2011AB)
272102008 (SNOMEDCT_2012_01_31)
MTHU021563 (LOINC Version 232)
C0439209 (UMLS CUI 2011AB)
258683005 (SNOMEDCT_2012_01_31)
Körperoberfläche
Item
Body Surface Area [sqm]:
float
C0005902 (UMLS CUI 2011AB)
301898006 (SNOMEDCT_2012_01_31)
10050311 (MedDRA 14.1)
C0457242 (UMLS CUI 2011AB)
278077005 (SNOMEDCT_2012_01_31)
Item Group
Daunorubicin
C0011015 (UMLS CUI 2011AB)
372715008 (SNOMEDCT_2012_01_31)
Day - actual
Item
Day - actual (scheduled 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 daily dose - actual (scheduled 60 mg/sqm intravenous for 2 h)
string
C2348070 (UMLS CUI 2011AB)
C0237400 (UMLS CUI 2011AB)
Gesamtdosis absolut (mg)
Item
Absolute total dose (mg)
float
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI 2011AB)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Dosisreduktion
Item
Dose Reduced
boolean
C1707814 (UMLS CUI 2011AB)
Item Group
Ara-C
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Day - actual
Item
Day - actual (scheduled 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 Daily dose - actual (scheduled 100 mg/sqm intravenous for 24 h)
string
C2348070 (UMLS CUI 2011AB)
C0237400 (UMLS CUI 2011AB)
Gesamtdosis absolut (mg)
Item
Absolute total dose (mg)
float
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI 2011AB)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Dosisreduktion
Item
Dose Reduced
boolean
C1707814 (UMLS CUI 2011AB)
Item Group
G-CSF dose:
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
begin
Item
Start date:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
end
Item
End date:
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Proprietary Name
Item
Proprietary Name:
string
C0592503 (UMLS CUI 2011AB)
Total dose
Item
Total Dose [ug]:
float
C2986497 (UMLS CUI 2011AB)
C0439211 (UMLS CUI 2011AB)
258685003 (SNOMEDCT_2012_01_31)
Item Group
Cytopenia duration:
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
C0449238 (UMLS CUI 2011AB)
103335007 (SNOMEDCT_2012_01_31)
MTHU001938 (LOINC Version 232)
start leukopenia
Item
Start date leucocytes <1,0 GPt/l or <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
End date (3x leucocytes >1,0 GPt/l or >=1000 /ul):
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
Ongoing cytopenia
Item
Ongoing cytopenia
boolean
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
C0750536 (UMLS CUI 2011AB)
start neutropenia
Item
Start date neutrophils <0,5 GPt/l or <500 /ul:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
end neutropenia
Item
End date (3x neutrophils >0,5 GPt/l or >=500 /ul):
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
Zytopenie andauernd
Item
Ongoing cytopenia
boolean
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
C0750536 (UMLS CUI 2011AB)
start thrombopenia
Item
Start date platelets <20 GPt/l or <20000 /ul:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
end thrombopenia
Item
End date (3x platelets>20 GPt/l or >=20000 /ul):
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
C0439243 (UMLS CUI 2011AB)
258774008 (SNOMEDCT_2012_01_31)
Zytopenie andauernd
Item
Ongoing cytopenia
boolean
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
C0750536 (UMLS CUI 2011AB)
Item Group
Transfusions:
Number of erythrocyte transfusions
Item
Number of erythrocyte transfusions
integer
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
ongoing erythrocyte transfusions
Item
ongoing erythrocyte transfusions
boolean
C0750536 (UMLS CUI 2011AB)
platelets single donors
Item
Number of platelet transfusions (single donors)
integer
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
ongoing thrombocyte transfusions
Item
ongoing thrombocyte transfusions
boolean
C0750536 (UMLS CUI 2011AB)
platelets pooled
Item
Number of platelet transfusions (pooled donors)
integer
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
ongoing thrombocyte transfusions
Item
ongoing thrombocyte transfusions
boolean
C0750536 (UMLS CUI 2011AB)
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 des Studienarztes/Unterschrift
Item
Name of study physician/Signature
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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