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)
- 1/19/18 1/19/18 -
- 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
nach 2. Induktionstherapie
- StudyEvent: ODM
- Eligibility criteria
- Ersterhebung
- Diagnostik vor Therapiebeginn
- 1. Induktionstherapie (DA)
- Induktionstherapie -Unerwünschte Ereignisse CTC 3.0-
- nach 1. Induktionstherapie
- 2. Induktionstherapie (DA)
- 2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Induktionstherapie
- 1. Postremissionstherapie (Ara-C/MAC)
- 1. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 1. Postremissionstherapie
- 2. Postremissionstherapie (Ara-C/MAMAC)
- 2. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Postremissionstherapie
- 3. Postremissionstherapie (Ara-C/MAC)
- 3. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 3. Postremissionstherapie
- Vor Stammzelltransplantation (SZT)
- Autologe SZT
- Allogene SZT
- SZT - Unerwünschte Ereignisse CTC 3.0 -
- Follow-up
- Rezidivbogen
- Schweres unerwünschtes Ereignis - SUE
Description
Blutbild
Alias
- UMLS CUI-1
- C0005771
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Leukocytes
Data type
float
Alias
- UMLS CUI [1]
- C0023508
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Hemoglobin
Data type
integer
Alias
- UMLS CUI [1]
- C0518015
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Blood platelets
Data type
float
Alias
- UMLS CUI [1]
- C0032181
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0948762
Description
Segmented neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0942466
Description
Band neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C1882076
Description
Lymphocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200635
Description
Monocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200637
Description
Eosinophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200638
Description
Basophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200641
Description
Myeloblasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0229633
Description
Promyelocyte count
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455279
Description
Myelocyte count
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455284
Description
Metamyelocyte count
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455285
Description
Klinische Chemie
Alias
- UMLS CUI-1
- C0008000
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Creatinine measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0201975
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Bilirubin measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0344395
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
AP
Data type
float
Alias
- UMLS CUI [1]
- C0201850
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
GOT/ASAT [umol/s*l]
Data type
float
Alias
- UMLS CUI [1]
- C0201899
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
GPT/ALAT
Data type
float
Alias
- UMLS CUI [1]
- C0201836
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
LDH
Data type
float
Alias
- UMLS CUI [1]
- C0202113
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Total proteine
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0555903
Description
KM-Morphologie
Alias
- UMLS CUI-1
- C2704380
Description
Bone marrow examination done?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005957
- UMLS CUI [1,2]
- C0884358
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Not done reason
Data type
text
Alias
- UMLS CUI [1]
- C2826287
Description
Blasts in Bone marrow
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C1982687
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Beurteilung des Therapieerfolges
Alias
- UMLS CUI-1
- C0085565
Description
Treatment outcome
Data type
integer
Alias
- UMLS CUI [1]
- C0085565
Description
Specify reason for evaluation impossible
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1272705
Description
Date of completion
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Risikogruppeneinteilung
Alias
- UMLS CUI-1
- C0035648
Description
Low risk aberrations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C3538919
Description
High risk aberrations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C0684030
Description
Stem cell donor
Data type
integer
Alias
- UMLS CUI [1]
- C0375877
Description
Stem cell donor relation type
Data type
integer
Alias
- UMLS CUI [1,1]
- C0375877
- UMLS CUI [1,2]
- C0369128
Description
Stem cell transplantation planned
Data type
integer
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C1301732
Description
Stem cell transplantation center
Data type
text
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0565990
Description
Geplante 1. Postremissionstherapie
Alias
- UMLS CUI-1
- C1511484
- UMLS CUI-2
- C1301732
Description
Planned first consolidation treatment trial arms
Data type
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C1522541
- UMLS CUI [1,3]
- C3538919
Description
Planned Consolidation treatment trial arm B
Data type
integer
Alias
- UMLS CUI [1,1]
- C3538919
- UMLS CUI [1,2]
- C1522541
Description
Planned Consolidation treatment trial arm D
Data type
integer
Alias
- UMLS CUI [1,1]
- C3538919
- UMLS CUI [1,2]
- C1522541
Description
Planned first consolidation treatment trial arms
Data type
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C1522541
- UMLS CUI [1,3]
- C1998074
Description
Chemotherapie number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0237753
Description
Standart risk trial arm B
Data type
integer
Alias
- UMLS CUI [1,1]
- C1998074
- UMLS CUI [1,2]
- C1522541
Description
Standart risk trial arm D
Data type
integer
Alias
- UMLS CUI [1,1]
- C1998074
- UMLS CUI [1,2]
- C1522541
Description
Planned first consolidation treatment trial arms
Data type
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C1522541
- UMLS CUI [1,3]
- C0684030
Description
Chemotherapy number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0237753
Description
High risk trial arm B
Data type
integer
Alias
- UMLS CUI [1,1]
- C0684030
- UMLS CUI [1,2]
- C1522541
Description
High risk trial arm D
Data type
integer
Alias
- UMLS CUI [1,1]
- C0684030
- UMLS CUI [1,2]
- C1522541
Description
Geplante 1. Postremissionstherapie
Alias
- UMLS CUI-1
- C1511484
- UMLS CUI-2
- C1301732
Description
planned first consolidation treatment trial arm
Data type
integer
Alias
- UMLS CUI [1]
- C1522541
Description
Planned first consolidation treatment t(8;21) trial arm A
Data type
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
Description
Planned first consolidation treatment t(8;21) trial arm C
Data type
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
Description
without t(8;21) no complex caryotype trial arm A
Data type
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
Description
Planned first consolidation treatment without t(8;21) no complex karyotype family donor availableboth arms
Data type
integer
Alias
- UMLS CUI [1,1]
- C0333683
- UMLS CUI [1,2]
- C0375877
- UMLS CUI [1,3]
- C0470187
Description
Planned first consolidation treatment without t(8;21) no complex karyotype without family donor trial arm A
Data type
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Description
Planned first consolidation treatment without t(8;21) no complex karyotype without family donor trial arm C
Data type
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Description
Planned Consolidation treatment complex caryotype trial arm A
Data type
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C3273253
Description
planned consolidation treatment Complex karyotype stem cell donor available both arms
Data type
integer
Alias
- UMLS CUI [1,1]
- C3273253
- UMLS CUI [1,2]
- C0375877
- UMLS CUI [1,3]
- C0470187
Description
Planned first consolidation treatment complex karyotype no stem cell donor available trail arm A
Data type
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Description
Planned first consolidation treatment complex karyotype no stem cell donor available trail arm C
Data type
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Description
Date of completion
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
nach 2. Induktionstherapie
- StudyEvent: ODM
- Eligibility criteria
- Ersterhebung
- Diagnostik vor Therapiebeginn
- 1. Induktionstherapie (DA)
- Induktionstherapie -Unerwünschte Ereignisse CTC 3.0-
- nach 1. Induktionstherapie
- 2. Induktionstherapie (DA)
- 2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Induktionstherapie
- 1. Postremissionstherapie (Ara-C/MAC)
- 1. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 1. Postremissionstherapie
- 2. Postremissionstherapie (Ara-C/MAMAC)
- 2. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Postremissionstherapie
- 3. Postremissionstherapie (Ara-C/MAC)
- 3. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 3. Postremissionstherapie
- Vor Stammzelltransplantation (SZT)
- Autologe SZT
- Allogene SZT
- SZT - Unerwünschte Ereignisse CTC 3.0 -
- Follow-up
- Rezidivbogen
- Schweres unerwünschtes Ereignis - SUE
C0520510 (UMLS CUI-2)
C0005953 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0229664 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1883469 (UMLS CUI [1,2])
C2097112 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1883469 (UMLS CUI [1,2])
C2238079 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0369128 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
C0565990 (UMLS CUI [1,2])
C1301732 (UMLS CUI-2)
C1522541 (UMLS CUI [1,2])
C3538919 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1998074 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C0684030 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1301732 (UMLS CUI-2)
C0333683 (UMLS CUI [1,2])
C0333683 (UMLS CUI [1,2])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
C3273253 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
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