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ID
12315
Beschreibung
Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) Form Description: Allogeneic Transplant Form
Stichworte
Versionen (3)
- 08.11.15 08.11.15 -
- 29.12.15 29.12.15 -
- 11.02.16 11.02.16 -
Hochgeladen am
8. November 2015
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Allogeneic Transplant Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Allogeneic Transplant Form
- StudyEvent: ODM
Ähnliche Modelle
Allogeneic Transplant Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Donor and Patient Characteristic at Entry
C1521970 (UMLS CUI-1)
Donor date of birth
Item
date
C0013018 (UMLS CUI [1,1])
C0005615 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005615 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
monozygotic twin (1)
C0041432 (UMLS CUI-1)
CL Item
HLA identical sibling (2)
M (UMLS CUI-1)
CL Item
HLA identical parent (3)
M (UMLS CUI-1)
CL Item
1-antigen-mismatched related donor (4)
M (UMLS CUI-1)
CL Item
2-or more-antigen mismatched related donor (haplo-identical) (5)
M (UMLS CUI-1)
CL Item
matched unrelated donor# (6)
M (UMLS CUI-1)
CL Item
mismatched unrelated donor## (7)
M (UMLS CUI-1)
CL Item
cord blood unit identified (8)
M (UMLS CUI-1)
CL Item
unknown (9)
Number of cord blood donors
Item
*number of cord blood donors
float
C0162371 (UMLS CUI [1,1])
C0013018 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0013018 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
EBMT risk score calculated
Item
EBMT risk score calculated (Appendix K)
boolean
C3826859 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
EBMT risk score
Item
EBMT risk score
float
C3826859 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
Comorbidity index calculated
Item
Comorbidity index calculated (Appendix J)
boolean
C1516737 (UMLS CUI [1])
Assessment Date
Item
Date of evaluation
date
C2985720 (UMLS CUI [1,1])
C1516737 (UMLS CUI [1,2])
C1516737 (UMLS CUI [1,2])
Comorbidity score
Item
float
C1516737 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
CL Item
non-myelo ablative (1)
CL Item
myelo ablative (2)
Date start
Item
date
C0376450 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Remission status
integer
C0544452 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0686584 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0449438 (UMLS CUI [1,2])
C0686584 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
CL Item
no CR(i) (0)
CL Item
CR (1)
CL Item
CRi (2)
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Cyclophosphamide total dose
Item
Cyclophosphamide total dose
float
C0010583 (UMLS CUI [1,1])
C3795627 (UMLS CUI [1,2])
C3795627 (UMLS CUI [1,2])
Busulfan total dose
Item
Busulfan total dose
float
C0006463 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
Busilvex total dose
Item
Busilvex total dose
float
C0006463 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
ATG total dose
Item
float
C0003442 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
Fludarabine total dose
Item
float
C0059985 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
Other chemotherapy
Item
boolean
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Specify
Item
*Specify
text
C3845569 (UMLS CUI [1])
Total body irradiation
Item
boolean
C0043162 (UMLS CUI [1])
Total dose
Item
Total dose
float
C2986497 (UMLS CUI [1])
Transplant date
Item
date
C3262321 (UMLS CUI [1])
CL Item
bone marrow (1)
CL Item
peripheral blood (2)
CL Item
BM + PB (3)
CL Item
cord blood (4)
Number of nucleated cells infused
Item
Number of nucleated cells infused
float
C1180059 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Number of CD34+ cells infused
Item
Number of CD34+ cells infused
float
C0882849 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
T-cell depletion
Item
boolean
C0677960 (UMLS CUI [1])
Specify
Item
*Specify
text
C0677960 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
Number of T-cells infused
Item
Number of T-cells infused
float
C0039194 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
MTX given
Item
boolean
C0025677 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
C0806914 (UMLS CUI [1,2])
Cyclosporin given
Item
boolean
C0010592 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
C0806914 (UMLS CUI [1,2])
Mycophenolate given
Item
Mycophenolate (Myfortic) given
boolean
C0209368 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
C0806914 (UMLS CUI [1,2])
Other
Item
Other*
boolean
C3845569 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
C0806914 (UMLS CUI [1,2])
Specify
Item
Specify
text
Comments
Item
text
C0947611 (UMLS CUI [1])