ID
44476
Beschrijving
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
Trefwoorden
Versies (2)
- 19-01-18 19-01-18 -
- 27-09-21 27-09-21 -
Houder van rechten
Technische Universität Dresden,Dr. Röllig
Geüploaded op
27 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102
Follow-up
- 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
Beschrijving
Abbruch der Behandlung
Alias
- UMLS CUI-1
- C0457454
Beschrijving
Discontinuation
Datatype
integer
Alias
- UMLS CUI [1]
- C0457454
Beschrijving
Date of discontinuation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0011008
Beschrijving
Reason for discontinuation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0457454
Beschrijving
Specify other reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Beschrijving
Therapie nach Studienabbruch
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0457454
- UMLS CUI-3
- C0231290
Beschrijving
SCT done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0872278
- UMLS CUI [1,2]
- C1272695
Beschrijving
Date of SCT
Datatype
date
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0011008
Beschrijving
Type of SCT
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0872278
- UMLS CUI [1,2]
- C0332307
Beschrijving
Donor relation
Datatype
integer
Alias
- UMLS CUI [1]
- C0369128
Beschrijving
Transplant type
Datatype
integer
Alias
- UMLS CUI [1]
- C3840412
Beschrijving
Follow up Beurteilung
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C1522577
Beschrijving
Assessment date
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
ECOG
Datatype
integer
Alias
- UMLS CUI [1]
- C1520224
Beschrijving
Evaluation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C2985720
Beschrijving
Date of Death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Date of last bone marrow biopsy
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Beschrijving
Allogeneic sct
Datatype
boolean
Alias
- UMLS CUI [1]
- C2242529
Beschrijving
Chronic GvHD
Datatype
boolean
Alias
- UMLS CUI [1]
- C0867389
Beschrijving
GvHD Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0867389
- UMLS CUI [1,2]
- C0439793
Beschrijving
Start date GvHD
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0018133
Beschrijving
Date last chimerism
Datatype
date
Alias
- UMLS CUI [1,1]
- C3703928
- UMLS CUI [1,2]
- C0011008
Beschrijving
Complete chimerism
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3703928
- UMLS CUI [1,2]
- C0205197
Beschrijving
partial chimerism, value
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C3703928
- UMLS CUI [1,2]
- C0205430
Beschrijving
Patient verstorben
Alias
- UMLS CUI-1
- C0011065
Beschrijving
Cause of death
Datatype
integer
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
Other cause of death
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Beschrijving
Causality
Datatype
integer
Alias
- UMLS CUI [1]
- C3641099
Beschrijving
SUE sheet completed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0205197
Beschrijving
Bestätigung
Alias
- UMLS CUI-1
- C0750484
Similar models
Follow-up
- 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
C0011008 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0457454 (UMLS CUI-2)
C0231290 (UMLS CUI-3)
C1272695 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
C0018133 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])