ID

13504

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)

Keywords

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

February 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Cytogenetic and FISH Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

English

Cytogenetic and FISH Form

1 forms  
Cytogenetic and FISH Form
Description

Cytogenetic and FISH Form

Patient date of birth
Description

Birth date

Data type

date

Measurement units
  • DD.MM.YYYY
Alias
UMLS CUI [1]
C0421451
DD.MM.YYYY
Cytogenetic study
Description

Cytogenetic study

Data type

integer

Alias
UMLS CUI [1]
C0010802
Date of sample for cytogenetic study
Description

sample date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0010802
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Type of examination
Description

Type of examination

Data type

integer

Alias
UMLS CUI [1]
C0456204
Number of mitoses examined
Description

Number of mitoses examined

Data type

integer

Alias
UMLS CUI [1,1]
C0026255
UMLS CUI [1,2]
C0750480
Number of banded cells fully analysed
Description

Number of banded cells fully analysed

Data type

float

Alias
UMLS CUI [1]
C3661517
General classification
Description

General classification

Data type

integer

Alias
UMLS CUI [1]
M
Number of cells with normal karyotype
Description

Number of cells with normal karyotype

Data type

float

Alias
UMLS CUI [1,1]
C0007634
UMLS CUI [1,2]
C0863140
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C1261273
Number of cells with clonal abnormality
Description

Number of cells with clonal abnormality

Data type

float

Alias
UMLS CUI [1,1]
C0007634
UMLS CUI [1,2]
C0476431
Nr of cells with complex (>=3) abnormalities
Description

Nr of cells with complex (>=3) abnormalities

Data type

float

Alias
UMLS CUI [1,1]
C0007634
UMLS CUI [1,2]
C0476431
Abnormalities present in
Description

Abnormalities present in

Data type

integer

Alias
UMLS CUI [1,1]
C0476431
UMLS CUI [1,2]
C0449475
Constitutional chromosome abnormality
Description

Constitutional chromosome abnormality

Data type

integer

Alias
UMLS CUI [1]
C3273253
*Specify
Description

*Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Karyotype (according to ISCN 2005) for complex karyotypes you can refer to included copy of original report
Description

Karyotype (according to ISCN 2005) for complex karyotypes you can refer to included copy of original report

Data type

text

Alias
UMLS CUI [1,1]
C1261273
UMLS CUI [1,2]
C2963412
FISH done
Description

FISH done

Data type

integer

Alias
UMLS CUI [1]
C0162789
Did FISH confirm cytogenetic results
Description

Did FISH confirm cytogenetic results

Data type

integer

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C0010802
*Specify
Description

*Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Comment Of The Reviewer
Description

Comment Of The Reviewer

Comment of the Reviewer
Description

Comment of the Reviewer

Data type

text

Alias
UMLS CUI [1]
C0947611
Date reviewed
Description

Date reviewed

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C3174387
dd/mm/yyyy
Signature reviewer
Description

Signature reviewer

Data type

text

Alias
UMLS CUI [1]
C2346576
Interphase FISH
Description

Interphase FISH

Alias
UMLS CUI-1
C2736045
Target code
Description

Target code

Data type

integer

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C1274040
Probe
Description

Probe

Data type

text

Alias
UMLS CUI [1]
C0016321
No. analysed
Description

No. analysed

Data type

float

Alias
UMLS CUI [1,1]
C0021798
UMLS CUI [1,2]
C0449788
loss %
Description

loss [%]

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C1517945
%
Normal [%]
Description

Normal [%]

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0205307
%
gain [%]
Description

gain [%]

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C1517378
%
transloc [%]
Description

transloc [%]

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0040715
%
Metaphase FISH
Description

Metaphase FISH

Metaphase FISH Describe results only if different from interphase FISH, e.g. elucidation of marker chromosomes etc. Also include a picture if this is more informative and results are not straightforward
Description

Metaphase FISH Describe results only if different from interphase FISH, e.g. elucidation of marker chromosomes etc. Also include a picture if this is more informative and results are not straightforward

Data type

text

Alias
UMLS CUI [1]
C2973230
Comment Of The Reviewer
Description

Comment Of The Reviewer

Comment of the Reviewer
Description

Comment of the Reviewer

Data type

text

Alias
UMLS CUI [1]
C0947611
Date reviewed
Description

Date reviewed

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C3174387
dd/mm/yyyy
Signature reviewer
Description

Signature reviewer

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Cytogenetic and FISH Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Cytogenetic and FISH Form
Birth date
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Item
Cytogenetic study
integer
C0010802 (UMLS CUI [1])
Cytogenetic study
Code List
Cytogenetic study
CL Item
not done 1=done successfully 2=failure (0)
sample date
Item
Date of sample for cytogenetic study
date
C0010802 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Type of examination
integer
C0456204 (UMLS CUI [1])
Type of examination
Code List
Type of examination
CL Item
BM  (1)
C0005953 (UMLS CUI-1)
CL Item
PB  (2)
C0229664 (UMLS CUI-1)
CL Item
both  (3)
C1706086 (UMLS CUI-1)
CL Item
other (8)
C0205394 (UMLS CUI-1)
Number of mitoses examined
Item
Number of mitoses examined
integer
C0026255 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Number of banded cells fully analysed
Item
Number of banded cells fully analysed
float
C3661517 (UMLS CUI [1])
Item
General classification
integer
M (UMLS CUI [1])
General classification
Code List
General classification
CL Item
NN 2=AN 3=AA (1)
Number of cells with normal karyotype
Item
Number of cells with normal karyotype
float
C0007634 (UMLS CUI [1,1])
C0863140 (UMLS CUI [1,2])
C0007634 (UMLS CUI [2,1])
C1261273 (UMLS CUI [2,2])
Number of cells with clonal abnormality
Item
Number of cells with clonal abnormality
float
C0007634 (UMLS CUI [1,1])
C0476431 (UMLS CUI [1,2])
Nr of cells with complex (>=3) abnormalities
Item
Nr of cells with complex (>=3) abnormalities
float
C0007634 (UMLS CUI [1,1])
C0476431 (UMLS CUI [1,2])
Item
Abnormalities present in
integer
C0476431 (UMLS CUI [1,1])
C0449475 (UMLS CUI [1,2])
Abnormalities present in
Code List
Abnormalities present in
CL Item
not present  (0)
CL Item
in non-related cell clones (2)
CL Item
in one or in related cell clones (1)
Item
Constitutional chromosome abnormality
integer
C3273253 (UMLS CUI [1])
Constitutional chromosome abnormality
Code List
Constitutional chromosome abnormality
CL Item
no  (0)
CL Item
yes*  (1)
CL Item
unknown (9)
*Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Karyotype (according to ISCN 2005) for complex karyotypes you can refer to included copy of original report
Item
Karyotype (according to ISCN 2005) for complex karyotypes you can refer to included copy of original report
text
C1261273 (UMLS CUI [1,1])
C2963412 (UMLS CUI [1,2])
Item
FISH done
integer
C0162789 (UMLS CUI [1])
FISH done
Code List
FISH done
CL Item
no  (0)
CL Item
yes, fill out next items and page 2 (1)
Item
Did FISH confirm cytogenetic results
integer
C0162789 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
Did FISH confirm cytogenetic results
Code List
Did FISH confirm cytogenetic results
CL Item
no*  (0)
CL Item
yes (1)
*Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Item Group
Comment Of The Reviewer
Comment of the Reviewer
Item
Comment of the Reviewer
text
C0947611 (UMLS CUI [1])
Date reviewed
Item
Date reviewed
date
C3174387 (UMLS CUI [1])
Signature reviewer
Item
Signature reviewer
text
C2346576 (UMLS CUI [1])
Item Group
Interphase FISH
C2736045 (UMLS CUI-1)
Item
Target code
integer
C0162789 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Target code
Code List
Target code
CL Item
5q (1)
CL Item
16q22/CBFB (5)
CL Item
chr 5 (11)
CL Item
21q22/AML1 (15)
CL Item
7q (2)
CL Item
t(8;21)(q22;q22) (6)
CL Item
chr 7 (12)
CL Item
3q26/EVI-1 (3)
CL Item
t(9;22)(q34;q11) (7)
CL Item
chr 8 (13)
CL Item
11q23/MLL (4)
CL Item
t(15;17)(q22;q21) (8)
CL Item
20q12 (14)
Probe
Item
Probe
text
C0016321 (UMLS CUI [1])
No. analysed
Item
No. analysed
float
C0021798 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
loss [%]
Item
loss %
float
C1517945 (UMLS CUI [1])
Normal [%]
Item
Normal [%]
integer
C0205307 (UMLS CUI [1])
gain [%]
Item
gain [%]
float
C1517378 (UMLS CUI [1])
transloc [%]
Item
transloc [%]
float
C0040715 (UMLS CUI [1])
Item Group
Metaphase FISH
Metaphase FISH Describe results only if different from interphase FISH, e.g. elucidation of marker chromosomes etc. Also include a picture if this is more informative and results are not straightforward
Item
Metaphase FISH Describe results only if different from interphase FISH, e.g. elucidation of marker chromosomes etc. Also include a picture if this is more informative and results are not straightforward
text
C2973230 (UMLS CUI [1])
Item Group
Comment Of The Reviewer
Comment of the Reviewer
Item
Comment of the Reviewer
text
C0947611 (UMLS CUI [1])
Date reviewed
Item
Date reviewed
date
C3174387 (UMLS CUI [1])
Signature reviewer
Item
Signature reviewer
text
C2346576 (UMLS CUI [1])
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