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

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

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

German

Follow-up

25 forms  
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
Abbruch der Behandlung
Description

Abbruch der Behandlung

Alias
UMLS CUI-1
C0457454
Abbruch durch
Description

Discontinuation

Data type

integer

Alias
UMLS CUI [1]
C0457454
Datum des Abbruchs
Description

Date of discontinuation

Data type

date

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0011008
Grund für den Abbruch
Description

Reason for discontinuation

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
Andere Gründe
Description

Specify other reason

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
Therapie nach Studienabbruch
Description

Therapie nach Studienabbruch

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0457454
UMLS CUI-3
C0231290
Patient wurde transplantiert
Description

SCT done

Data type

boolean

Alias
UMLS CUI [1,1]
C0872278
UMLS CUI [1,2]
C1272695
Datum der Transplantation
Description

Date of SCT

Data type

date

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0011008
Art der SZT
Description

Type of SCT

Data type

integer

Alias
UMLS CUI [1,1]
C0872278
UMLS CUI [1,2]
C0332307
Verwandtschaftsgrad des Spenders
Description

Donor relation

Data type

integer

Alias
UMLS CUI [1]
C0369128
Art des Transplantats
Description

Transplant type

Data type

integer

Alias
UMLS CUI [1]
C3840412
Follow up Beurteilung
Description

Follow up Beurteilung

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C1522577
Stichtag
Description

Assessment date

Data type

date

Alias
UMLS CUI [1]
C2985720
ECOG Status
Description

ECOG

Data type

integer

Alias
UMLS CUI [1]
C1520224
Beurteilung zum Zeitpunkt des Stichtages
Description

Evaluation

Data type

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C2985720
Todesdatum
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C1148348
letzte KM-Punktion
Description

Date of last bone marrow biopsy

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005954
Bei allogener SZT
Description

Allogeneic sct

Data type

boolean

Alias
UMLS CUI [1]
C2242529
Chronische GvHD
Description

Chronic GvHD

Data type

boolean

Alias
UMLS CUI [1]
C0867389
GvHD Intensität
Description

GvHD Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0867389
UMLS CUI [1,2]
C0439793
Datum Beginn
Description

Start date GvHD

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0018133
Datum letzter Chimärismus
Description

Date last chimerism

Data type

date

Alias
UMLS CUI [1,1]
C3703928
UMLS CUI [1,2]
C0011008
Vollständiger Chimärismus
Description

Complete chimerism

Data type

boolean

Alias
UMLS CUI [1,1]
C3703928
UMLS CUI [1,2]
C0205197
Unvollständiger Chimärismus,Wert
Description

partial chimerism, value

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C3703928
UMLS CUI [1,2]
C0205430
%
Patient verstorben
Description

Patient verstorben

Alias
UMLS CUI-1
C0011065
Todesursache
Description

Cause of death

Data type

integer

Alias
UMLS CUI [1]
C0007465
Andere Todesursache
Description

Other cause of death

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C1521902
Steht die Todesursache mit der Studientherapie in Verbindung?
Description

Causality

Data type

integer

Alias
UMLS CUI [1]
C3641099
SUE ausgefüllt?
Description

SUE sheet completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205197
Bestätigung
Description

Bestätigung

Alias
UMLS CUI-1
C0750484
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
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Similar models

Follow-up

25 forms
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])
Gender
Code List
Geschlecht
CL Item
männlich (1)
CL Item
weiblich (2)
Item Group
Abbruch der Behandlung
C0457454 (UMLS CUI-1)
Item
Abbruch durch
integer
C0457454 (UMLS CUI [1])
Discontinuation
Code List
Abbruch durch
CL Item
Arzt (1)
CL Item
Patient (2)
Date of discontinuation
Item
Datum des Abbruchs
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Grund für den Abbruch
integer
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Reason for discontinuation
Code List
Grund für den Abbruch
CL Item
Nebenwirkungen (1)
CL Item
Dosisreduktion (2)
CL Item
Therapieversagen nach IT1 (3)
CL Item
keine komplette Remission nach IT2 (4)
CL Item
Tod (5)
CL Item
andere Gründe (6)
Specify other reason
Item
Andere Gründe
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Therapie nach Studienabbruch
C0087111 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
C0231290 (UMLS CUI-3)
SCT done
Item
Patient wurde transplantiert
boolean
C0872278 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Date of SCT
Item
Datum der Transplantation
date
C1504389 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Art der SZT
integer
C0872278 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Sct other timepoint
Code List
Art der SZT
CL Item
allogen (1)
CL Item
autolog (2)
Item
Verwandtschaftsgrad des Spenders
integer
C0369128 (UMLS CUI [1])
Stem cell donor relation type
Code List
Verwandtschaftsgrad des Spenders
CL Item
Familienspender (1)
CL Item
Fremdspender (2)
Item
Art des Transplantats
integer
C3840412 (UMLS CUI [1])
Transplant type
Code List
Art des Transplantats
CL Item
PBSZ (1)
CL Item
KM (2)
Item Group
Follow up Beurteilung
C0220825 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Assessment date
Item
Stichtag
date
C2985720 (UMLS CUI [1])
Item
ECOG Status
integer
C1520224 (UMLS CUI [1])
ECOG
Code List
ECOG Status
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Item
Beurteilung zum Zeitpunkt des Stichtages
integer
C0220825 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Evaluation
Code List
Beurteilung zum Zeitpunkt des Stichtages
CL Item
Induktionstherapie noch nicht abgeschlossen (1)
CL Item
keine komplette Remission nach IT2 (2)
CL Item
Aplasie (3)
CL Item
Rezidiv (Rezidivbogen ausfüllen) (4)
CL Item
Vollremission (5)
CL Item
verstorben, Todesdatum (6)
CL Item
Therapieversagen nach IT1 (7)
CL Item
unbekannt (8)
Date of Death
Item
Todesdatum
date
C1148348 (UMLS CUI [1])
Date of last bone marrow biopsy
Item
letzte KM-Punktion
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
Allogeneic sct
Item
Bei allogener SZT
boolean
C2242529 (UMLS CUI [1])
Chronic GvHD
Item
Chronische GvHD
boolean
C0867389 (UMLS CUI [1])
Item
GvHD Intensität
integer
C0867389 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
GvHD Intensity
Code List
GvHD Intensität
CL Item
limitiert (1)
CL Item
extensiv (2)
Start date GvHD
Item
Datum Beginn
date
C0808070 (UMLS CUI [1,1])
C0018133 (UMLS CUI [1,2])
Date last chimerism
Item
Datum letzter Chimärismus
date
C3703928 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Complete chimerism
Item
Vollständiger Chimärismus
boolean
C3703928 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
partial chimerism, value
Item
Unvollständiger Chimärismus,Wert
integer
C3703928 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
Item Group
Patient verstorben
C0011065 (UMLS CUI-1)
Item
Todesursache
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Todesursache
CL Item
Rezidiv/Therapieversager (1)
CL Item
neue maligne Erkrankung (2)
CL Item
Infektion unbekannter Ursache (3)
CL Item
Pneumonie (4)
CL Item
virale Infektion (5)
CL Item
Pilzinfektion (6)
CL Item
Parasiteninfektion (7)
CL Item
Organversagen (8)
CL Item
Blutung (9)
CL Item
Medikamenten-Toxizität (10)
CL Item
akute GvHD (11)
CL Item
chronische GvHD (12)
CL Item
Markversagen oder Abstoßung (13)
CL Item
VOD (14)
CL Item
andere (15)
CL Item
unbekannt (16)
Other cause of death
Item
Andere Todesursache
text
C0007465 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Steht die Todesursache mit der Studientherapie in Verbindung?
integer
C3641099 (UMLS CUI [1])
Stem cell donor
Code List
Steht die Todesursache mit der Studientherapie in Verbindung?
CL Item
Ja (1)
CL Item
Nein (2)
CL Item
Unbekannt (3)
SUE sheet completed
Item
SUE ausgefüllt?
boolean
C1519255 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
Bestätigung
C0750484 (UMLS CUI-1)
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])
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