ID

13495

Description

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

Keywords

Versions (3)
  1. 11/8/15 11/8/15 -
  2. 12/29/15 12/29/15 -
  3. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

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License

Creative Commons BY-NC 3.0
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Allogeneic Transplant Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

English

Allogeneic Transplant Form

1 forms  
Donor and Patient Characteristic at Entry
Description

Donor and Patient Characteristic at Entry

Alias
UMLS CUI-1
C0365288
Donor date of birth
Description

Donor date of birth

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0005615
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
Relation with patient
Description

Donor Relation

Data type

integer

Alias
UMLS CUI [1]
C0369128
*number of cord blood donors
Description

Number of cord blood donors

Data type

float

Alias
UMLS CUI [1,1]
C0162371
UMLS CUI [1,2]
C0013018
UMLS CUI [1,3]
C0750480
EBMT Risk Score
Description

EBMT Risk Score

Alias
UMLS CUI-1
C3826859
UMLS CUI-2
C0449820
EBMT risk score calculated (Appendix K)
Description

EBMT risk score calculated

Data type

boolean

Alias
UMLS CUI [1,1]
C3826859
UMLS CUI [1,2]
C0449820
EBMT risk score
Description

EBMT risk score

Data type

float

Alias
UMLS CUI [1,1]
C3826859
UMLS CUI [1,2]
C0449820
Comorbidity Index
Description

Comorbidity Index

Alias
UMLS CUI-1
C1516737
Comorbidity index calculated (Appendix J)
Description

Comorbidity index calculated

Data type

boolean

Alias
UMLS CUI [1]
C1516737
Date of evaluation
Description

Assessment Date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1516737
dd/mm/yyyy
Comorbidity score
Description

Comorbidity score

Data type

float

Alias
UMLS CUI [1,1]
C1516737
UMLS CUI [1,2]
C0449820
Conditioning
Description

Conditioning

Alias
UMLS CUI-1
C0376450
Conditioning
Description

Conditioning

Data type

integer

Alias
UMLS CUI [1]
C0376450
Date start
Description

Date start

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0376450
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Remission status
Description

Remission status

Data type

integer

Alias
UMLS CUI [1]
C1704632
Patient weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Drug
Description

Drug

Alias
UMLS CUI-1
C0013227
Cyclophosphamide total dose
Description

Cyclophosphamide total dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C2986497
mg
Busulfan total dose
Description

Busulfan total dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0006463
UMLS CUI [1,2]
C2986497
mg
Busilvex total dose
Description

Busilvex total dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0006463
UMLS CUI [1,2]
C2986497
mg
ATG total dose
Description

ATG total dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0003442
UMLS CUI [1,2]
C2986497
mg
Fludarabine total dose
Description

Fludarabine total dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0059985
UMLS CUI [1,2]
C2986497
mg
Other chemotherapy
Description

Other chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205394
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C3845569
Total body irradiation
Description

Total body irradiation

Data type

boolean

Alias
UMLS CUI [1]
C0043162
Total dose
Description

Total dose

Data type

float

Measurement units
  • Gy
Alias
UMLS CUI [1]
C2986497
Gy
Transplant
Description

Transplant

Alias
UMLS CUI-1
C0472699
Transplant date
Description

Transplant date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C3262321
dd/mm/yyyy
Source of stem cells (actually infused)
Description

Source of stem cells

Data type

integer

Alias
UMLS CUI [1]
C0018956
Number of nucleated cells infused
Description

Number of nucleated cells infused

Data type

float

Measurement units
  • 10^8/kg
Alias
UMLS CUI [1,1]
C1180059
UMLS CUI [1,2]
C0750480
10^8/kg
Number of CD34+ cells infused
Description

Number of CD34+ cells infused

Data type

float

Measurement units
  • 10^6/kg
Alias
UMLS CUI [1,1]
C0882849
UMLS CUI [1,2]
C0750480
10^6/kg
T-cell depletion
Description

T-cell depletion

Data type

boolean

Alias
UMLS CUI [1]
C0677960
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1,1]
C0677960
UMLS CUI [1,2]
C3845569
Number of T-cells infused
Description

Number of T-cells infused

Data type

float

Measurement units
  • 10^4/kg
Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0750480
10^4/kg
GvHD Prevention
Description

GvHD Prevention

Alias
UMLS CUI-1
C0018133
UMLS CUI-2
C0199176
MTX given
Description

MTX given

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0806914
Cyclosporin given
Description

Cyclosporin given

Data type

boolean

Alias
UMLS CUI [1,1]
C0010592
UMLS CUI [1,2]
C0806914
Mycophenolate (Myfortic) given
Description

Mycophenolate given

Data type

boolean

Alias
UMLS CUI [1,1]
C0209368
UMLS CUI [1,2]
C0806914
Other*
Description

Other

Data type

boolean

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C0806914
Specify
Description

Specify

Data type

text

Comments
Description

Comments

Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Allogeneic Transplant Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Donor and Patient Characteristic at Entry
C0365288 (UMLS CUI-1)
Donor date of birth
Item
Donor date of birth
date
C0013018 (UMLS CUI [1,1])
C0005615 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Relation with patient
integer
C0369128 (UMLS CUI [1])
Donor Relation
Code List
Relation with patient
CL Item
monozygotic twin (1)
C0041432 (UMLS CUI-1)
CL Item
HLA identical sibling (2)
C0037047 (UMLS CUI-1)
CL Item
HLA identical parent (3)
C0030551 (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)
C0439673 (UMLS CUI-1)
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])
Item Group
EBMT Risk Score
C3826859 (UMLS CUI-1)
C0449820 (UMLS CUI-2)
EBMT risk score calculated
Item
EBMT risk score calculated (Appendix K)
boolean
C3826859 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
EBMT risk score
Item
EBMT risk score
float
C3826859 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Comorbidity Index
C1516737 (UMLS CUI-1)
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])
Comorbidity score
Item
Comorbidity score
float
C1516737 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Conditioning
C0376450 (UMLS CUI-1)
Item
Conditioning
integer
C0376450 (UMLS CUI [1])
Conditioning
Code List
Conditioning
CL Item
non-myelo ablative  (1)
C1831742 (UMLS CUI-1)
CL Item
myelo ablative (2)
C1513784 (UMLS CUI-1)
Date start
Item
Date start
date
C0376450 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Remission status
integer
C1704632 (UMLS CUI [1])
Remission status
Code List
Remission status
CL Item
no CR(i)  (0)
C3844738 (UMLS CUI-1)
CL Item
CR  (1)
C0677874 (UMLS CUI-1)
CL Item
CRi (2)
C3538993 (UMLS CUI-1)
Weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Item Group
Drug
C0013227 (UMLS CUI-1)
Cyclophosphamide total dose
Item
Cyclophosphamide total dose
float
C0010583 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Busulfan total dose
Item
Busulfan total dose
float
C0006463 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Busilvex total dose
Item
Busilvex total dose
float
C0006463 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
ATG total dose
Item
ATG total dose
float
C0003442 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Fludarabine total dose
Item
Fludarabine total dose
float
C0059985 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Other chemotherapy
Item
Other chemotherapy
boolean
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Specify
Item
*Specify
text
C3845569 (UMLS CUI [1])
Total body irradiation
Item
Total body irradiation
boolean
C0043162 (UMLS CUI [1])
Total dose
Item
Total dose
float
C2986497 (UMLS CUI [1])
Item Group
Transplant
C0472699 (UMLS CUI-1)
Transplant date
Item
Transplant date
date
C3262321 (UMLS CUI [1])
Item
Source of stem cells (actually infused)
integer
C0018956 (UMLS CUI [1])
Source of stem cells
Code List
Source of stem cells (actually infused)
CL Item
bone marrow  (1)
C0005953 (UMLS CUI-1)
CL Item
peripheral blood (2)
C0229664 (UMLS CUI-1)
CL Item
BM + PB (3)
C0005953 (UMLS CUI-1)
C0229664 (UMLS CUI-2)
CL Item
cord blood (4)
C0162371 (UMLS CUI-1)
Number of nucleated cells infused
Item
Number of nucleated cells infused
float
C1180059 (UMLS CUI [1,1])
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])
T-cell depletion
Item
T-cell depletion
boolean
C0677960 (UMLS CUI [1])
Specify
Item
*Specify
text
C0677960 (UMLS CUI [1,1])
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])
Item Group
GvHD Prevention
C0018133 (UMLS CUI-1)
C0199176 (UMLS CUI-2)
MTX given
Item
MTX given
boolean
C0025677 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
Cyclosporin given
Item
Cyclosporin given
boolean
C0010592 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
Mycophenolate given
Item
Mycophenolate (Myfortic) given
boolean
C0209368 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
Other
Item
Other*
boolean
C3845569 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
Specify
Item
Specify
text
Item Group
Comments
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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