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

Rezidivbogen

Demografie
Description

Demografie

Alias
UMLS CUI-1
C0011298
Klinik-Nr
Description

Hospital number

Data type

integer

Alias
UMLS CUI [1]
C0806432
Patienten-Nr.:
Description

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patienten-Initialen
Description

Patient initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Name
Description

Patient name

Data type

text

Alias
UMLS CUI [1]
C1299487
Vorname
Description

Given name

Data type

text

Alias
UMLS CUI [1]
C1443235
Geburtsdatum
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Geschlecht
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
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
Rezidiv festgestellt am (Diagnosedatum)
Description

Recidiv diagnosis date

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0034897
Wievieltes Rezidiv
Description

Recidiv number

Data type

integer

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0750480
Ort des Rezidivs
Description

Ort des Rezidivs

Alias
UMLS CUI-1
C0034897
UMLS CUI-2
C0450429
Ort des Rezidivs
Description

Recidiv location

Data type

integer

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0450429
andere Lokalisation
Description

Other location

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205394
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
Klinischer Befund
Description

Klinischer Befund

Alias
UMLS CUI-1
C2607943
Blutungen
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
Infektionen:
Description

Infections

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Temperatur > 38°C
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Gingivahyperplasie
Description

Gingival Hyperplasia

Data type

boolean

Alias
UMLS CUI [1]
C0017566
Lymphome
Description

Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024299
Lebergröße (in MCL sonographisch)
Description

Liver size

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0426688
UMLS CUI [1,2]
C0041618
cm
Milzgröße (Länge sonographisch)
Description

size of spleen

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0412541
UMLS CUI [1,2]
C0552406
cm
Extramedulläre Manifestation
Description

extramedullary manifestation

Data type

boolean

Alias
UMLS CUI [1]
C1868812
Extramedulläre Manifestation, Lokalisation:
Description

extramedullary manifestation localization

Data type

text

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C1521902
andere Symptome
Description

other symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205394
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
Rezidiv Behandlung
Description

Rezidiv Behandlung

Alias
UMLS CUI-1
C0040808
UMLS CUI-2
C0277556
Rezidivtherapie
Description

Recidiv treatment

Data type

integer

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0277556
Andere
Description

Other treatment protocol

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0040808
Beurteilung des Therapieerfolges
Description

Beurteilung des Therapieerfolges

Alias
UMLS CUI-1
C0085565
Datum
Description

Outcome assessment date

Data type

date

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C2985720
Therapieerfolg
Description

Treatment outcome

Data type

integer

Alias
UMLS CUI [1]
C0085565
Datum
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
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

Similar models

Rezidivbogen

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demografie
C0011298 (UMLS CUI-1)
Hospital number
Item
Klinik-Nr
integer
C0806432 (UMLS CUI [1])
Patient ID
Item
Patienten-Nr.:
integer
C2348585 (UMLS CUI [1])
Patient initials
Item
Patienten-Initialen
text
C2986440 (UMLS CUI [1])
Patient name
Item
Name
text
C1299487 (UMLS CUI [1])
Given name
Item
Vorname
text
C1443235 (UMLS CUI [1])
Date of birth
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 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])
Recidiv diagnosis date
Item
Rezidiv festgestellt am (Diagnosedatum)
date
C2316983 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Recidiv number
Item
Wievieltes Rezidiv
integer
C0034897 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item Group
Ort des Rezidivs
C0034897 (UMLS CUI-1)
C0450429 (UMLS CUI-2)
Item
Ort des Rezidivs
integer
C0034897 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Code List
Ort des Rezidivs
CL Item
Knochenmark/Blut (1)
CL Item
Haut (2)
CL Item
ZNS (3)
CL Item
anderer (4)
Other location
Item
andere Lokalisation
text
C1515974 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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
Klinischer Befund
C2607943 (UMLS CUI-1)
Hemorrhage
Item
Blutungen
boolean
C0019080 (UMLS CUI [1])
Infections
Item
Infektionen:
boolean
C0009450 (UMLS CUI [1])
Fever
Item
Temperatur > 38°C
boolean
C0015967 (UMLS CUI [1])
Gingival Hyperplasia
Item
Gingivahyperplasie
boolean
C0017566 (UMLS CUI [1])
Lymphoma
Item
Lymphome
boolean
C0024299 (UMLS CUI [1])
Liver size
Item
Lebergröße (in MCL sonographisch)
integer
C0426688 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
size of spleen
Item
Milzgröße (Länge sonographisch)
integer
C0412541 (UMLS CUI [1,1])
C0552406 (UMLS CUI [1,2])
extramedullary manifestation
Item
Extramedulläre Manifestation
boolean
C1868812 (UMLS CUI [1])
extramedullary manifestation localization
Item
Extramedulläre Manifestation, Lokalisation:
text
C1868812 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
other symptoms
Item
andere Symptome
text
C1457887 (UMLS CUI [1,1])
C0205394 (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
Rezidiv Behandlung
C0040808 (UMLS CUI-1)
C0277556 (UMLS CUI-2)
Item
Rezidivtherapie
integer
C0040808 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Code List
Rezidivtherapie
CL Item
Mito FLAG (1)
CL Item
andere (2)
Other treatment protocol
Item
Andere
text
C0205394 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
Item Group
Beurteilung des Therapieerfolges
C0085565 (UMLS CUI-1)
Outcome assessment date
Item
Datum
date
C0085565 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Therapieerfolg
integer
C0085565 (UMLS CUI [1])
Code List
Therapieerfolg
CL Item
Vollremission (1)
CL Item
Aplasie (2)
CL Item
Therapieversagen (3)
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Investigator name
Item
Name des Studienarztes
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Unterschrift
text
C2346576 (UMLS CUI [1])

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