ID

44476

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

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

Technische Universität Dresden,Dr. Röllig

Uploaded on

September 27, 2021

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

Allogene SZT

Spenderdaten
Description

Spenderdaten

Alias
UMLS CUI-1
C0013018
UMLS CUI-2
C1320722
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
Geburtsdatum
Description

Patient Birth Date

Data type

date

Alias
UMLS CUI [1]
C0421451
Geschlecht
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Verwandschaftsgrad des Spenders
Description

Donor relation to patient

Data type

integer

Alias
UMLS CUI [1]
C0369128
Blutgruppe
Description

Blood group

Data type

integer

Alias
UMLS CUI [1]
C0005810
Rhesusfaktor
Description

Rhesus factor

Data type

integer

Alias
UMLS CUI [1]
C0035403
CMV-Status
Description

CMV-Status

Data type

integer

Alias
UMLS CUI [1]
C0582172
HLA-Kompatibilität
Description

HLA Compatibility

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C2348930
Größe
Description

Patient height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0489786
cm
Gewicht
Description

Patient weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Körperoberfläche
Description

Body surface

Data type

float

Measurement units
  • m2
Alias
UMLS CUI [1]
C0005902
m2
HLA-Kompatibilität
Description

HLA-Kompatibilität

Alias
UMLS CUI-1
C0013018
UMLS CUI-2
C2348930
Mismatch
Description

Mismatch

Data type

integer

Alias
UMLS CUI [1]
C1881865
Allogene SZT Konditionierung
Description

Allogene SZT Konditionierung

Alias
UMLS CUI-1
C0376450
UMLS CUI-2
C1515895
Konditionierung Fludarabin i.v
Description

Conditioning agent Fludarabin

Data type

boolean

Alias
UMLS CUI [1,1]
C0059985
UMLS CUI [1,2]
C0376450
Behandlungstag Fludarabin -6 bis -2
Description

Treatment day fludarabine -6 bis -2

Data type

boolean

Alias
UMLS CUI [1,1]
C0059985
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
Fludarabin Tagesdosis 30 mg/m²
Description

Fludarabine daily dose

Data type

boolean

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0059985
Fludarabin Gesamtdosis
Description

Fludarabine cumulative dose

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0059985
mg
Konditionierung Melphalan
Description

Conditioning agent Melphalan

Data type

boolean

Alias
UMLS CUI [1,1]
C0025241
UMLS CUI [1,2]
C0376450
Melphalan Behandlungstag -2
Description

Treatment day Melphalan

Data type

boolean

Alias
UMLS CUI [1,1]
C0025241
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0750480
Melphalan Tagesdosis 150mg/m²
Description

Melphalan daily dose

Data type

boolean

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0025241
Melphalan Gesamtdosis
Description

Melphalan cumulative dose

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0025241
mg
Konditionierung ATG-Fresenius i.v
Description

(wenn Fremdspender)

Data type

boolean

Alias
UMLS CUI [1,1]
C0003442
UMLS CUI [1,2]
C0376450
Behandlungstag ATG-Fresenius -5bis -2
Description

Treatment day ATG-Fresenius -5bis -2

Data type

boolean

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0003442
ATG-Fresenius Tagesdosis 10 mg/m²
Description

ATG-Fresenius daily dose

Data type

boolean

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0003442
ATG-Fresenius Gesamtdosis
Description

ATG-Fresenius cumulative dose

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0003442
mg
Andere Konditionierung Substanz
Description

Other Conditioning agent

Data type

text

Alias
UMLS CUI [1,1]
C0376450
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0013227
Art der Verabreichung
Description

Drug Administration Routes

Data type

text

Alias
UMLS CUI [1]
C0013153
Behandlungstag
Description

Treatment day

Data type

text

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
Tagesdosis
Description

Daily dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Gesamtdosis
Description

Cumulative dose

Data type

text

Alias
UMLS CUI [1]
C2986497
Transplantat
Description

Transplantat

Alias
UMLS CUI-1
C1504389
Art des Transplantats
Description

Transplant type

Data type

integer

Alias
UMLS CUI [1,1]
C3840412
UMLS CUI [1,2]
C2242529
nukleäre Zellen (TNC)
Description

nucleated cells

Data type

integer

Measurement units
  • *10^8 /kg
Alias
UMLS CUI [1,1]
C1180059
UMLS CUI [1,2]
C0007584
*10^8 /kg
CD34+ Zellen
Description

CD34+ Cells

Data type

integer

Measurement units
  • *10^6/kg
Alias
UMLS CUI [1]
C1277788
*10^6/kg
CD3 (T-Zellen)
Description

CD3 (T-Cells)

Data type

integer

Measurement units
  • *10^5 /kg
Alias
UMLS CUI [1]
C2025558
*10^5 /kg
Kompletter Chimärismus in ersten 30 Tagen erreicht
Description

Complete Chimerism within 30 days

Data type

boolean

Alias
UMLS CUI [1,1]
C0333678
UMLS CUI [1,2]
C3845590
Max. Wert
Description

maximum value

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0806909
%
Datum
Description

Date of complete chimerism

Data type

date

Alias
UMLS CUI [1,1]
C3703928
UMLS CUI [1,2]
C0011008
akute GvHD
Description

Acute graft versus host disease

Data type

integer

Alias
UMLS CUI [1]
C0856825
GvHD Grad, Haut
Description

Gvhd grade skin

Data type

integer

Alias
UMLS CUI [1,1]
C4273340
UMLS CUI [1,2]
C0441800
GvHD Grad Darm
Description

Gvhd grade colon

Data type

integer

Alias
UMLS CUI [1,1]
C1334228
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0009368
GvHD Grad Leber
Description

Gvhd grade liver

Data type

integer

Alias
UMLS CUI [1,1]
C4273346
UMLS CUI [1,2]
C0441800
Materialversand an Studienzentrale
Description

Materialversand an Studienzentrale

Alias
UMLS CUI-1
C1524049
UMLS CUI-2
C0520510
mind. 10 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. 40 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
Datum
Description

Date of completion

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287
Name des Studienarztes
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Beurteilung Engraftment
Description

Beurteilung Engraftment

Alias
UMLS CUI-1
C0301944
UMLS CUI-2
C1516048
Engraftment
Description

Engraftment

Data type

boolean

Alias
UMLS CUI [1]
C0301944
Neutrophile Engraftment Take Datum
Description

3x >0,5 GPt/l bzw . ≥ 500 /μl

Data type

date

Alias
UMLS CUI [1,1]
C1882078
UMLS CUI [1,2]
C0011008
Andauernd
Description

Sustained

Data type

boolean

Alias
UMLS CUI [1]
C3827885
Thrombozyten Engraftment Take Datum
Description

3x >20 GPt/l bzw . ≥ 20.000 /μl

Data type

date

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0011008
Andauernd
Description

Sustained

Data type

boolean

Alias
UMLS CUI [1]
C3827885
Thrombozyten Engraftment Take Datum
Description

3x >50 GPt/l bzw . ≥ 50.000 /μl

Data type

date

Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0011008
Andauernd
Description

Sustained

Data type

boolean

Alias
UMLS CUI [1]
C3827885
Anzahl Erythrozythentransfusionen
Description

Number red blood cell transfusions

Data type

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0750480
Andauernd
Description

sustained

Data type

boolean

Alias
UMLS CUI [1]
C0443318
Thrombozyten Transfusion
Description

Platelet transfusion

Data type

integer

Alias
UMLS CUI [1]
C0086818
Anzahl Einzelspender Transfusionen
Description

Count of Platelet transfusions

Data type

integer

Alias
UMLS CUI [1,1]
C0086818
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C1277092
andauernd
Description

Sustained

Data type

boolean

Alias
UMLS CUI [1]
C0443318
Anzahl gepoolter Thrombozyten Transfusionen
Description

Count of pooled platelet transfusions

Data type

integer

Alias
UMLS CUI [1,1]
C0086818
UMLS CUI [1,2]
C1277095
UMLS CUI [1,3]
C0750480
andauernd
Description

Sustained

Data type

boolean

Alias
UMLS CUI [1]
C0443318
Anzahl Granulozytentransfusionen
Description

Count of granulocyte transfusions

Data type

integer

Alias
UMLS CUI [1,1]
C0085430
UMLS CUI [1,2]
C0018183
UMLS CUI [1,3]
C0750480
SZT-spezifische Nebenwirkungen
Description

SCT specific adverse events

Data type

integer

Alias
UMLS CUI [1,1]
C0371849
UMLS CUI [1,2]
C0877248
SZT-spezifische Nebenwirkungen, sonstige
Description

SCT specific adverse event , specify other

Data type

text

Alias
UMLS CUI [1,1]
C0371849
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3845569
Materialversand an Studienzentrale
Description

Materialversand an Studienzentrale

Alias
UMLS CUI-1
C1524049
UMLS CUI-2
C0520510
mind. 10 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. 40 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
KM-Morphologie
Description

KM-Morphologie

Alias
UMLS CUI-1
C2704380
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
Blastenanteil im KM
Description

Blasts in Bone marrow

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C1982687
%
Labor
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C1882331
Beurteilung des Therapieerfolges
Description

Beurteilung des Therapieerfolges

Alias
UMLS CUI-1
C0085565
Status nach SZT (nach Regeneration)
Description

Status post SCT

Data type

integer

Alias
UMLS CUI [1,1]
C0371849
UMLS CUI [1,2]
C0085415
SZT-assoziierter Todesfall: wievielter Tag nach SZT
Description

SCT associated death day number post-treatment

Data type

integer

Alias
UMLS CUI [1,1]
C0371849
UMLS CUI [1,2]
C0206277
UMLS CUI [1,3]
C2709088
Datum
Description

Date of completion

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287
Name des Studienarztes
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Signature Unterschrift
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576

Similar models

Allogene SZT

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Spenderdaten
C0013018 (UMLS CUI-1)
C1320722 (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])
Patient Birth Date
Item
Geburtsdatum
date
C0421451 (UMLS CUI [1])
Item
Geschlecht
integer
C0079399 (UMLS CUI [1])
Code List
Geschlecht
CL Item
männlich (1)
CL Item
weiblich (2)
Item
Verwandschaftsgrad des Spenders
integer
C0369128 (UMLS CUI [1])
Code List
Verwandschaftsgrad des Spenders
CL Item
Familienspender (1)
CL Item
Fremdspender (2)
Item
Blutgruppe
integer
C0005810 (UMLS CUI [1])
Code List
Blutgruppe
CL Item
A (1)
CL Item
B (2)
CL Item
AB (3)
CL Item
0 (4)
Item
Rhesusfaktor
integer
C0035403 (UMLS CUI [1])
Code List
Rhesusfaktor
CL Item
Negativ (0)
CL Item
Positiv (1)
Item
CMV-Status
integer
C0582172 (UMLS CUI [1])
Code List
CMV-Status
CL Item
positiv (1)
CL Item
negativ (2)
CL Item
unbekannt (3)
HLA Compatibility
Item
HLA-Kompatibilität
boolean
C0013018 (UMLS CUI [1,1])
C2348930 (UMLS CUI [1,2])
Patient height
Item
Größe
integer
C0489786 (UMLS CUI [1])
Patient weight
Item
Gewicht
integer
C0005910 (UMLS CUI [1])
Body surface
Item
Körperoberfläche
float
C0005902 (UMLS CUI [1])
Item Group
HLA-Kompatibilität
C0013018 (UMLS CUI-1)
C2348930 (UMLS CUI-2)
Item
Mismatch
integer
C1881865 (UMLS CUI [1])
Code List
Mismatch
CL Item
HLA-A (1)
C0019728 (UMLS CUI-1)
(Comment:de)
CL Item
HLA-B (2)
C0019737 (UMLS CUI-1)
(Comment:de)
CL Item
HLA-C (3)
C0019751 (UMLS CUI-1)
(Comment:de)
CL Item
DRB 1 (4)
(Comment:de)
CL Item
DQB 1 (5)
(Comment:de)
Item Group
Allogene SZT Konditionierung
C0376450 (UMLS CUI-1)
C1515895 (UMLS CUI-2)
Conditioning agent Fludarabin
Item
Konditionierung Fludarabin i.v
boolean
C0059985 (UMLS CUI [1,1])
C0376450 (UMLS CUI [1,2])
Treatment day fludarabine -6 bis -2
Item
Behandlungstag Fludarabin -6 bis -2
boolean
C0059985 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Fludarabine daily dose
Item
Fludarabin Tagesdosis 30 mg/m²
boolean
C2348070 (UMLS CUI [1,1])
C0059985 (UMLS CUI [1,2])
Fludarabine cumulative dose
Item
Fludarabin Gesamtdosis
integer
C2986497 (UMLS CUI [1,1])
C0059985 (UMLS CUI [1,2])
Conditioning agent Melphalan
Item
Konditionierung Melphalan
boolean
C0025241 (UMLS CUI [1,1])
C0376450 (UMLS CUI [1,2])
Treatment day Melphalan
Item
Melphalan Behandlungstag -2
boolean
C0025241 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Melphalan daily dose
Item
Melphalan Tagesdosis 150mg/m²
boolean
C2348070 (UMLS CUI [1,1])
C0025241 (UMLS CUI [1,2])
Melphalan cumulative dose
Item
Melphalan Gesamtdosis
integer
C2986497 (UMLS CUI [1,1])
C0025241 (UMLS CUI [1,2])
Conditioning agent ATG-Fresenius
Item
Konditionierung ATG-Fresenius i.v
boolean
C0003442 (UMLS CUI [1,1])
C0376450 (UMLS CUI [1,2])
Treatment day ATG-Fresenius -5bis -2
Item
Behandlungstag ATG-Fresenius -5bis -2
boolean
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0003442 (UMLS CUI [1,3])
ATG-Fresenius daily dose
Item
ATG-Fresenius Tagesdosis 10 mg/m²
boolean
C2348070 (UMLS CUI [1,1])
C0003442 (UMLS CUI [1,2])
ATG-Fresenius cumulative dose
Item
ATG-Fresenius Gesamtdosis
integer
C2986497 (UMLS CUI [1,1])
C0003442 (UMLS CUI [1,2])
Other Conditioning agent
Item
Andere Konditionierung Substanz
text
C0376450 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Item
Art der Verabreichung
text
C0013153 (UMLS CUI [1])
Code List
Art der Verabreichung
Treatment day
Item
Behandlungstag
text
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Daily dose
Item
Tagesdosis
text
C2348070 (UMLS CUI [1])
Cumulative dose
Item
Gesamtdosis
text
C2986497 (UMLS CUI [1])
Item Group
Transplantat
C1504389 (UMLS CUI-1)
Item
Art des Transplantats
integer
C3840412 (UMLS CUI [1,1])
C2242529 (UMLS CUI [1,2])
Code List
Art des Transplantats
CL Item
PBSZ (1)
CL Item
KM (2)
nucleated cells
Item
nukleäre Zellen (TNC)
integer
C1180059 (UMLS CUI [1,1])
C0007584 (UMLS CUI [1,2])
CD34+ Cells
Item
CD34+ Zellen
integer
C1277788 (UMLS CUI [1])
CD3 (T-Cells)
Item
CD3 (T-Zellen)
integer
C2025558 (UMLS CUI [1])
Complete Chimerism within 30 days
Item
Kompletter Chimärismus in ersten 30 Tagen erreicht
boolean
C0333678 (UMLS CUI [1,1])
C3845590 (UMLS CUI [1,2])
maximum value
Item
Max. Wert
integer
C0587081 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Date of complete chimerism
Item
Datum
date
C3703928 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
akute GvHD
integer
C0856825 (UMLS CUI [1])
Code List
akute GvHD
CL Item
Ja (1)
CL Item
Nein (2)
CL Item
Unbekannt (3)
Item
GvHD Grad, Haut
integer
C4273340 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Code List
GvHD Grad, Haut
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
GvHD Grad Darm
integer
C1334228 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0009368 (UMLS CUI [1,3])
Code List
GvHD Grad Darm
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
GvHD Grad Leber
integer
C4273346 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Code List
GvHD Grad Leber
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item Group
Materialversand an Studienzentrale
C1524049 (UMLS CUI-1)
C0520510 (UMLS CUI-2)
Bone marrow heparinized
Item
mind. 10 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. 40 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])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
Investigator name
Item
Name des Studienarztes
text
C2826892 (UMLS CUI [1])
Investigator Signature
Item
Unterschrift
text
C2346576 (UMLS CUI [1])
Item Group
Beurteilung Engraftment
C0301944 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Engraftment
Item
Engraftment
boolean
C0301944 (UMLS CUI [1])
Neutrophils graft acceptance date
Item
Neutrophile Engraftment Take Datum
date
C1882078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sustained
Item
Andauernd
boolean
C3827885 (UMLS CUI [1])
Platelets graft acceptance date
Item
Thrombozyten Engraftment Take Datum
date
C1882407 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sustained
Item
Andauernd
boolean
C3827885 (UMLS CUI [1])
Platelets graft acceptance date
Item
Thrombozyten Engraftment Take Datum
date
C1882407 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sustained
Item
Andauernd
boolean
C3827885 (UMLS CUI [1])
Number red blood cell transfusions
Item
Anzahl Erythrozythentransfusionen
integer
C0086252 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
sustained
Item
Andauernd
boolean
C0443318 (UMLS CUI [1])
Item
Thrombozyten Transfusion
integer
C0086818 (UMLS CUI [1])
Code List
Thrombozyten Transfusion
CL Item
Einzelspender (1)
CL Item
gepoolt (2)
Count of Platelet transfusions
Item
Anzahl Einzelspender Transfusionen
integer
C0086818 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C1277092 (UMLS CUI [1,3])
Sustained
Item
andauernd
boolean
C0443318 (UMLS CUI [1])
Count of pooled platelet transfusions
Item
Anzahl gepoolter Thrombozyten Transfusionen
integer
C0086818 (UMLS CUI [1,1])
C1277095 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Sustained
Item
andauernd
boolean
C0443318 (UMLS CUI [1])
Count of granulocyte transfusions
Item
Anzahl Granulozytentransfusionen
integer
C0085430 (UMLS CUI [1,1])
C0018183 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Item
SZT-spezifische Nebenwirkungen
integer
C0371849 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
SZT-spezifische Nebenwirkungen
CL Item
Markversagen / Abstoßung (1)
CL Item
VOD (2)
CL Item
sonstige (3)
SCT specific adverse event , specify other
Item
SZT-spezifische Nebenwirkungen, sonstige
text
C0371849 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Item Group
Materialversand an Studienzentrale
C1524049 (UMLS CUI-1)
C0520510 (UMLS CUI-2)
Bone marrow heparinized
Item
mind. 10 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. 40 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])
Item Group
KM-Morphologie
C2704380 (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])
Blasts in Bone marrow
Item
Blastenanteil im KM
integer
C1982687 (UMLS CUI [1])
Laboratory Name
Item
Labor
text
C1882331 (UMLS CUI [1])
Item Group
Beurteilung des Therapieerfolges
C0085565 (UMLS CUI-1)
Item
Status nach SZT (nach Regeneration)
integer
C0371849 (UMLS CUI [1,1])
C0085415 (UMLS CUI [1,2])
Code List
Status nach SZT (nach Regeneration)
CL Item
komplette Remission (1)
CL Item
SZT-assoziierter Todesfall (2)
CL Item
Transplantatversagen (3)
CL Item
Rezidiv (4)
SCT associated death day number post-treatment
Item
SZT-assoziierter Todesfall: wievielter Tag nach SZT
integer
C0371849 (UMLS CUI [1,1])
C0206277 (UMLS CUI [1,2])
C2709088 (UMLS CUI [1,3])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
Investigator name
Item
Name des Studienarztes
text
C2826892 (UMLS CUI [1])
Investigator Signature
Item
Signature Unterschrift
text
C2346576 (UMLS CUI [1])

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