ID

43301

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00180102

Nyckelord

Versioner (3)
  1. 2013-07-30 2013-07-30 - Martin Dugas
  2. 2015-08-26 2015-08-26 - Martin Dugas
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

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

Tysk Engelsk

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

1 Formulär  
General information
Beskrivning

General information

Alias
SNOMEDCT_2012_01_31
106227002
UMLS CUI-1
C1508263
Clinic no.:
Beskrivning

Klinik-Nr.

Datatyp

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-
Beskrivning

Patienten-Nr.

Datatyp

integer

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

Patienten-Initialen

Datatyp

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:
Beskrivning

Beginn

Datatyp

date

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

Ende

Datatyp

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Size
Beskrivning

Height

Datatyp

float

Måttenheter
  • cm
Alias
SNOMEDCT_2012_01_31
246115007
LOINC Version 232
MTHU010347
SNOMEDCT_2012_01_31
258672001
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
SNOMEDCT_2012_01_31
272102008
LOINC Version 232
MTHU021563
SNOMEDCT_2012_01_31
258683005
UMLS CUI [1]
C0005910
kg
Body Surface Area
Beskrivning

BSA

Datatyp

float

Måttenheter
  • m²
Alias
SNOMEDCT_2012_01_31
301898006
MedDRA 14.1
10050311
SNOMEDCT_2012_01_31
278077005
UMLS CUI [1]
C0005902
m²
Daunorubicin
Beskrivning

Daunorubicin

Alias
UMLS CUI 2011AB
C0011015
SNOMEDCT_2012_01_31
372715008
Day - actual (scheduled 3-5)
Beskrivning

Day - actual

Datatyp

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)
Beskrivning

Daily dose - actual

Datatyp

string

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

Total dose absolute

Datatyp

float

Måttenheter
  • mg
Alias
SNOMEDCT_2012_01_31
56136002
SNOMEDCT_2012_01_31
258684004
UMLS CUI [1]
C2986497
mg
Dose Reduced
Beskrivning

Dosisreduktion

Datatyp

boolean

Alias
UMLS CUI 2011AB
C1707814
Ara-C
Beskrivning

Ara-C

Alias
UMLS CUI 2011AB
C0010711
SNOMEDCT_2012_01_31
89265009
Day - actual (scheduled 1-7)
Beskrivning

Day - actual

Datatyp

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)
Beskrivning

Daily dose - actual

Datatyp

string

Alias
UMLS CUI 2011AB
C2348070
UMLS CUI 2011AB
C0237400
Absolute total dose
Beskrivning

Total dose absolute

Datatyp

float

Måttenheter
  • mg
Alias
SNOMEDCT_2012_01_31
56136002
SNOMEDCT_2012_01_31
258684004
UMLS CUI [1]
C2986497
mg
Dose Reduced
Beskrivning

Dosis reduction

Datatyp

boolean

Alias
UMLS CUI [1]
C1707814
G-CSF dose:
Beskrivning

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:
Beskrivning

begin

Datatyp

date

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

end

Datatyp

date

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

Proprietary Name

Datatyp

string

Alias
UMLS CUI 2011AB
C0592503
Total Dose
Beskrivning

Total dose

Datatyp

float

Måttenheter
  • µg
Alias
SNOMEDCT_2012_01_31
258685003
UMLS CUI [1]
C2986497
µg
Cytopenia duration:
Beskrivning

Cytopenia duration:

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
Start date leucocytes <1,0 GPt/l or <1000 /ul:
Beskrivning

start leukopenia

Datatyp

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):
Beskrivning

end leukpenia

Datatyp

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Ongoing cytopenia
Beskrivning

Ongoing cytopenia

Datatyp

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0549178
Start date neutrophils <0,5 GPt/l or <500 /ul:
Beskrivning

start neutropenia

Datatyp

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):
Beskrivning

end neutropenia

Datatyp

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Ongoing cytopenia
Beskrivning

Zytopenie andauernd

Datatyp

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0549178
Start date platelets <20 GPt/l or <20000 /ul:
Beskrivning

start thrombopenia

Datatyp

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):
Beskrivning

end thrombopenia

Datatyp

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
UMLS CUI 2011AB
C0439243
SNOMEDCT_2012_01_31
258774008
Ongoing cytopenia
Beskrivning

Zytopenie andauernd

Datatyp

boolean

Alias
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AB
C0549178
Transfusions:
Beskrivning

Transfusions:

Alias
UMLS CUI-1
C1879316
Number of erythrocyte transfusions
Beskrivning

Number of erythrocyte transfusions

Datatyp

integer

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

ongoing erythrocyte transfusions

Datatyp

boolean

Alias
UMLS CUI 2011AB
C0549178
Number of platelet transfusions (single donors)
Beskrivning

platelets single donors

Datatyp

integer

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

ongoing thrombocyte transfusions

Datatyp

boolean

Alias
UMLS CUI 2011AB
C0549178
Number of platelet transfusions (pooled donors)
Beskrivning

platelets pooled

Datatyp

integer

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

ongoing thrombocyte transfusions

Datatyp

boolean

Alias
UMLS CUI 2011AB
C0549178
Signature
Beskrivning

Signature

Alias
UMLS CUI-1
C1519316
Date
Beskrivning

Datum

Datatyp

date

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

Name des Studienarztes/Unterschrift

Datatyp

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
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General information
106227002 (SNOMEDCT_2012_01_31)
C1508263 (UMLS CUI-1)
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)
Height
Item
Size
float
246115007 (SNOMEDCT_2012_01_31)
MTHU010347 (LOINC Version 232)
258672001 (SNOMEDCT_2012_01_31)
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
272102008 (SNOMEDCT_2012_01_31)
MTHU021563 (LOINC Version 232)
258683005 (SNOMEDCT_2012_01_31)
C0005910 (UMLS CUI [1])
BSA
Item
Body Surface Area
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
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)
Total dose absolute
Item
Absolute total dose (mg)
float
56136002 (SNOMEDCT_2012_01_31)
258684004 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI [1])
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)
Total dose absolute
Item
Absolute total dose
float
56136002 (SNOMEDCT_2012_01_31)
258684004 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI [1])
Dosis reduction
Item
Dose Reduced
boolean
C1707814 (UMLS CUI [1])
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
float
258685003 (SNOMEDCT_2012_01_31)
C2986497 (UMLS CUI [1])
Item Group
Cytopenia duration:
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
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)
C0549178 (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)
C0549178 (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)
C0549178 (UMLS CUI 2011AB)
Item Group
Transfusions:
C1879316 (UMLS CUI-1)
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
C0549178 (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
C0549178 (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
C0549178 (UMLS CUI 2011AB)
Item Group
Signature
C1519316 (UMLS CUI-1)
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)
Tillbaka till toppen 

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