ID

28493

Description

NCT00180102 AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. Phase 4 Study Type:Interventional Study Design:Allocation: Randomized Intervention Model:Factorial Assignment Masking:None (Open Label) Primary Purpose:Treatment Medical Department I, University Hospital Carl Gustav Carus Dresden, Germany, 01307 Sponsors and Collaborators Technische Universität Dresden Principal Investigator:Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden

Keywords

Versions (2)
  1. 1/19/18 1/19/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

Technische Universität Dresden,Dr. Röllig

Uploaded on

January 19, 2018

DOI

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License

Creative Commons BY-NC 3.0
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AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102

German

Diagnostik vor Therapiebeginn

25 forms  
Materialversand an Studienzentrale
Description

Materialversand an Studienzentrale

Alias
UMLS CUI-1
C1524049
UMLS CUI-2
C0520510
Klinik nummer
Description

Hospital number

Data type

integer

Alias
UMLS CUI [1]
C0806432
Patienten-Nr
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patienten-Initialen:
Description

Patient initials

Data type

text

Alias
UMLS CUI [1]
C2986440
mind. 15 ml heparinisiertes KM
Description

Bone marrow heparinized

Data type

boolean

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0005953
Datum
Description

Shipping date

Data type

date

Alias
UMLS CUI [1,1]
C1524049
UMLS CUI [1,2]
C0011008
mind. 50 ml heparinisiertes pB
Description

heparinized pB

Data type

boolean

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0229664
Datum
Description

Shipping date

Data type

date

Alias
UMLS CUI [1,1]
C1524049
UMLS CUI [1,2]
C0011008
5 ungefärbte KM-Ausstriche
Description

bone marrow smears

Data type

boolean

Alias
UMLS CUI [1,1]
C0205451
UMLS CUI [1,2]
C1883469
UMLS CUI [1,3]
C2097112
Datum
Description

Shipping date

Data type

date

Alias
UMLS CUI [1,1]
C1524049
UMLS CUI [1,2]
C0011008
5 ungefärbte pB-Ausstriche
Description

peripheral blood smears

Data type

boolean

Alias
UMLS CUI [1,1]
C0205451
UMLS CUI [1,2]
C1883469
UMLS CUI [1,3]
C2238079
Datum
Description

Shipping date

Data type

date

Alias
UMLS CUI [1,1]
C1524049
UMLS CUI [1,2]
C0011008
20 ml EDTA-Blut für HLA-Typisierung
Description

EDTA-Blood for HLA-Typing

Data type

boolean

Alias
UMLS CUI [1,1]
C2919842
UMLS CUI [1,2]
C0242318
Datum
Description

Shipping date

Data type

date

Alias
UMLS CUI [1,1]
C1524049
UMLS CUI [1,2]
C0011008
Potentieller Familienspender vorhanden?
Description

Potential family donor

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C3494891
Wenn ja, Anzahl der Geschwister
Description

If yes, count of siblings

Data type

integer

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C0750480
20 ml EDTA-Blut für jedes Geschwister
Description

EDTA-Blood of each living related donor

Data type

boolean

Alias
UMLS CUI [1,1]
C2919842
UMLS CUI [1,2]
C3494891
Wenn nein, warum?
Description

If no, reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Blutbild
Description

Blutbild

Alias
UMLS CUI-1
C0005771
Datum
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Leukozyten
Description

Leukocytes

Data type

float

Alias
UMLS CUI [1]
C0023508
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
Hämoglobin
Description

Hemoglobin

Data type

integer

Alias
UMLS CUI [1]
C0518015
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
Thrombozyten
Description

Blood platelets

Data type

float

Alias
UMLS CUI [1]
C0032181
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
Datum Diff.-Blutbild
Description

Date of differential blood count

Data type

date

Alias
UMLS CUI [1,1]
C0545131
UMLS CUI [1,2]
C0011008
Neutrophile
Description

Neutrophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0948762
%
Segmentkernige
Description

Segmented neutrophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0942466
%
Stabkernige
Description

Band neutrophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C1882076
%
Lymphozyten
Description

Lymphocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200635
%
Monozyten
Description

Monocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200637
%
Eosinophile
Description

Eosinophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200638
%
Basophile
Description

Basophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
Myeloblasten
Description

Myeloblasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0580952
%
Promyelozyten
Description

Promyelocyte count

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455279
%
Myelozyten
Description

Myelocyte count

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455284
%
Metamyelozyten
Description

Metamyelocyte count

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455285
%
Klinische Chemie
Description

Klinische Chemie

Alias
UMLS CUI-1
C0008000
Datum
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Kreatinin
Description

Creatinine measurement

Data type

integer

Alias
UMLS CUI [1]
C0201975
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
Bilirubin
Description

bilirubin measurement

Data type

integer

Alias
UMLS CUI [1]
C0344395
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
AP
Description

AP

Data type

float

Alias
UMLS CUI [1]
C0201850
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
GOT/ASAT
Description

GOT/ASAT [umol/s*l]

Data type

float

Alias
UMLS CUI [1]
C0201899
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
GPT/ALAT
Description

GPT/ALAT

Data type

float

Alias
UMLS CUI [1]
C0201836
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
LDH
Description

LDH

Data type

float

Alias
UMLS CUI [1]
C0202113
Verwendete Einheit
Description

Unit of measure

Data type

integer

Alias
UMLS CUI [1]
C1519795
Gesamteiweiß
Description

Total proteine

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0555903
g/L
Diagnostik
Description

Diagnostik

Alias
UMLS CUI-1
C0430022
KM-Morphologie durchgeführt?
Description

Bone marrow examination done?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005957
UMLS CUI [1,2]
C0884358
Datum
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Grund für Nichtdurchführung
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Labor
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C1882331
Zytogenetik durchgeführt?
Description

Cytogenetic done?

Data type

boolean

Alias
UMLS CUI [1]
C0752095
Datum
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Grund für Nichtdurchführung
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Labor
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C1882331
Immunphänotypisierung durchgeführt?
Description

Immunophenotyping

Data type

boolean

Alias
UMLS CUI [1]
C0079611
Datum
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Grund für Nichtdurchführung
Description

Not done reason

Data type

text

Alias
UMLS CUI [1]
C2826287
Labor
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C1882331
FLT3:
Description

FLT3

Data type

integer

Alias
UMLS CUI [1]
C0251006
FLT3-ratio:
Description

FLT3-ratio

Data type

float

Alias
UMLS CUI [1,1]
C0251006
UMLS CUI [1,2]
C0456603
Datum
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Name des Studienarztes
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Diagnostik vor Therapiebeginn

25 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Materialversand an Studienzentrale
C1524049 (UMLS CUI-1)
C0520510 (UMLS CUI-2)
Hospital number
Item
Klinik nummer
integer
C0806432 (UMLS CUI [1])
Patient number
Item
Patienten-Nr
integer
C2348585 (UMLS CUI [1])
Patient initials
Item
Patienten-Initialen:
text
C2986440 (UMLS CUI [1])
Bone marrow heparinized
Item
mind. 15 ml heparinisiertes KM
boolean
C0019134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Shipping date
Item
Datum
date
C1524049 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
heparinized pB
Item
mind. 50 ml heparinisiertes pB
boolean
C0019134 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Shipping date
Item
Datum
date
C1524049 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
bone marrow smears
Item
5 ungefärbte KM-Ausstriche
boolean
C0205451 (UMLS CUI [1,1])
C1883469 (UMLS CUI [1,2])
C2097112 (UMLS CUI [1,3])
Shipping date
Item
Datum
date
C1524049 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
peripheral blood smears
Item
5 ungefärbte pB-Ausstriche
boolean
C0205451 (UMLS CUI [1,1])
C1883469 (UMLS CUI [1,2])
C2238079 (UMLS CUI [1,3])
Shipping date
Item
Datum
date
C1524049 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
EDTA-Blood for HLA-Typing
Item
20 ml EDTA-Blut für HLA-Typisierung
boolean
C2919842 (UMLS CUI [1,1])
C0242318 (UMLS CUI [1,2])
Shipping date
Item
Datum
date
C1524049 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Potential family donor
Item
Potentieller Familienspender vorhanden?
boolean
C0470187 (UMLS CUI [1,1])
C3494891 (UMLS CUI [1,2])
If yes, count of siblings
Item
Wenn ja, Anzahl der Geschwister
integer
C0037047 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
EDTA-Blood of each living related donor
Item
20 ml EDTA-Blut für jedes Geschwister
boolean
C2919842 (UMLS CUI [1,1])
C3494891 (UMLS CUI [1,2])
If no, reason
Item
Wenn nein, warum?
text
C2826287 (UMLS CUI [1])
Item Group
Blutbild
C0005771 (UMLS CUI-1)
date
Item
Datum
date
C0011008 (UMLS CUI [1])
Leukocytes
Item
Leukozyten
float
C0023508 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
GPt/l (1)
CL Item
/μl (2)
Hemoglobin
Item
Hämoglobin
integer
C0518015 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
mmol/l (1)
CL Item
g/dl (2)
Blood platelets
Item
Thrombozyten
float
C0032181 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
GPt/l (1)
CL Item
/μl (2)
Date of differential blood count
Item
Datum Diff.-Blutbild
date
C0545131 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Neutrophils
Item
Neutrophile
float
C0948762 (UMLS CUI [1])
Segmented neutrophils
Item
Segmentkernige
float
C0942466 (UMLS CUI [1])
Band neutrophils
Item
Stabkernige
float
C1882076 (UMLS CUI [1])
Lymphocytes
Item
Lymphozyten
float
C0200635 (UMLS CUI [1])
Monocytes
Item
Monozyten
float
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophile
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophile
float
C0200641 (UMLS CUI [1])
Myeloblasts
Item
Myeloblasten
float
C0580952 (UMLS CUI [1])
Promyelocyte count
Item
Promyelozyten
float
C0455279 (UMLS CUI [1])
Myelocyte count
Item
Myelozyten
float
C0455284 (UMLS CUI [1])
Metamyelocyte count
Item
Metamyelozyten
float
C0455285 (UMLS CUI [1])
Item Group
Klinische Chemie
C0008000 (UMLS CUI-1)
Date
Item
Datum
date
C0011008 (UMLS CUI [1])
Creatinine measurement
Item
Kreatinin
integer
C0201975 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
mg/dl (1)
CL Item
μmol/l (2)
bilirubin measurement
Item
Bilirubin
integer
C0344395 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
mg/dl (1)
CL Item
μmol/l (2)
AP
Item
AP
float
C0201850 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
mg/dl (1)
CL Item
μmol/l (2)
GOT/ASAT [umol/s*l]
Item
GOT/ASAT
float
C0201899 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
umol/s*l (1)
CL Item
U/l (2)
GPT/ALAT
Item
GPT/ALAT
float
C0201836 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
umol/s*l (1)
CL Item
U/l (2)
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Item
Verwendete Einheit
integer
C1519795 (UMLS CUI [1])
Unit of measure
Code List
Verwendete Einheit
CL Item
umol/s*l (1)
CL Item
U/l (2)
Total proteine
Item
Gesamteiweiß
float
C0555903 (UMLS CUI [1])
Item Group
Diagnostik
C0430022 (UMLS CUI-1)
Bone marrow examination done?
Item
KM-Morphologie durchgeführt?
boolean
C0005957 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Date
Item
Datum
date
C0011008 (UMLS CUI [1])
Not done reason
Item
Grund für Nichtdurchführung
text
C2826287 (UMLS CUI [1])
Laboratory Name
Item
Labor
text
C1882331 (UMLS CUI [1])
Cytogenetic done?
Item
Zytogenetik durchgeführt?
boolean
C0752095 (UMLS CUI [1])
Date
Item
Datum
date
C0011008 (UMLS CUI [1])
Not done reason
Item
Grund für Nichtdurchführung
text
C2826287 (UMLS CUI [1])
Laboratory Name
Item
Labor
text
C1882331 (UMLS CUI [1])
Immunophenotyping
Item
Immunphänotypisierung durchgeführt?
boolean
C0079611 (UMLS CUI [1])
Date
Item
Datum
date
C0011008 (UMLS CUI [1])
Not done reason
Item
Grund für Nichtdurchführung
text
C2826287 (UMLS CUI [1])
Laboratory Name
Item
Labor
text
C1882331 (UMLS CUI [1])
Item
FLT3:
integer
C0251006 (UMLS CUI [1])
FLT3
Code List
FLT3:
CL Item
negativ (1)
CL Item
positiv (2)
CL Item
nicht auswertbar (3)
CL Item
unbekannt (4)
FLT3-ratio
Item
FLT3-ratio:
float
C0251006 (UMLS CUI [1,1])
C0456603 (UMLS CUI [1,2])
Date
Item
Datum
date
C0011008 (UMLS CUI [1])
Investigator name
Item
Name des Studienarztes
text
C2826892 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])
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