Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Study Drop-out
Item
Study Drop-out?
boolean
C2348568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Date of discontinuation
Item
Date of premature study termination
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason
integer
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Patient withdrew consent (1)
CL Item
(Serious) adverse event (2)
CL Item
Neither aspirate nor biopsy of BM done (at Visit 7) (4)
CL Item
No assessment of extracted bone marrow possible (at Visit 7) (5)
CL Item
Patient is lacking compliance (6)
CL Item
Violation inclusion/exclusion criteria (7)
CL Item
Investigator‘s decision (8)
CL Item
Death (Please fill in Death sheet) (9)
CL Item
Other reasons (10)
CL Item
Suboptimal responder (blast > = 5% at Visit 7) (3)
Consent withdrawal reason
Item
Please document reason and circumstances of the patient‘s withdrawal
text
C2349954 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Number of (S)AE
Item
Number of (S)AE in database documentation
integer
C2826275 (UMLS CUI [1])
C1519255 (UMLS CUI [2,1])
C0600091 (UMLS CUI [2,2])
Specify protocol violation
Item
Violation inclusion/exclusion criteria, please specify
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify Investigators decision
Item
Specify Investigators decision
text
C0008961 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Specify other reason
Item
Specify other reason
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Drop-Out Visit not done
Item
Drop-Out Visit not done
boolean
C0457454 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Electrocardiography
integer
C1623258 (UMLS CUI [1])
Code List
Electrocardiography
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item
ECG findings
integer
C0438154 (UMLS CUI [1])
CL Item
no pathological findings (1)
(Comment:en)
CL Item
new pathological findings (2)
(Comment:en)
Item
Pathological ECG findings
integer
C1832603 (UMLS CUI [1])
Code List
Pathological ECG findings
CL Item
clinically NOT significant findings (1)
CL Item
clinically significant findings (2)
Significant ECG findings
Item
Significant ECG findings
text
C0438154 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Item
Echocardiography
integer
C0013516 (UMLS CUI [1])
Code List
Echocardiography
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
LVEF
Item
LV ejection fraction
integer
C0428772 (UMLS CUI [1])
valvular defects
Item
Any valvular defects?
boolean
C2748945 (UMLS CUI [1])
Tricuspid valve defect
Item
Tricuspid valve defect
boolean
C0264882 (UMLS CUI [1])
Item
Tricuspid valve type of defect
integer
C0264882 (UMLS CUI [1])
Code List
Tricuspid valve type of defect
CL Item
Insufficiency (1)
Item
Degree of Tricuspid valve defect
integer
C0457451 (UMLS CUI [1,1])
C0264882 (UMLS CUI [1,2])
Code List
Degree of Tricuspid valve defect
Pulmonary valve defect
Item
Pulmonary valve defect
boolean
C0034087 (UMLS CUI [1])
Item
Pulmonary valve type of defect
integer
C0034087 (UMLS CUI [1])
Code List
Pulmonary valve type of defect
CL Item
Insufficiency (1)
Item
Degree of pulmonary valve defect
integer
C0457451 (UMLS CUI [1,1])
C0034087 (UMLS CUI [1,2])
Code List
Degree of pulmonary valve defect
Mitral valve defect
Item
Mitral valve defect
boolean
C0026265 (UMLS CUI [1])
Item
Mitral valve type of defect
integer
C0026265 (UMLS CUI [1])
Code List
Mitral valve type of defect
CL Item
Insufficiency (1)
Item
Degree of Mitral valve defect
integer
C0457451 (UMLS CUI [1,1])
C0026265 (UMLS CUI [1,2])
Code List
Degree of Mitral valve defect
Aortic valve defect
Item
Aortic valve defect
boolean
C1260873 (UMLS CUI [1])
Item
Aortic valve type of defect
integer
C1260873 (UMLS CUI [1])
Code List
Aortic valve type of defect
CL Item
Insufficiency (1)
Item
Degree of aortic valve defect
integer
C0457451 (UMLS CUI [1,1])
C1260873 (UMLS CUI [1,2])
Code List
Degree of aortic valve defect
Item
Cardiac Enzymes
integer
C0201934 (UMLS CUI [1])
Code List
Cardiac Enzymes
Date of sampling
Item
Date of sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
NT-proBNP
Item
NT-proBNP value
float
C3272900 (UMLS CUI [1])
Item
Unit for NT-proBNP
integer
C1519795 (UMLS CUI [1])
Code List
Unit for NT-proBNP
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnT
Item
Troponin T value
float
C0523953 (UMLS CUI [1])
Item
Unit for TNT
integer
C1519795 (UMLS CUI [1])
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnI
Item
Troponin I value
float
C0920210 (UMLS CUI [1])
Item
Unit for TnI
integer
C1519795 (UMLS CUI [1])
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Neutropenia grade IV
Item
Neutropenia grade IV
boolean
C0027947 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Preexisting neutropenia
Item
1st neutropenia preexisting at V1?
boolean
C0027947 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Neutropenia onset date
Item
Date of onset of 1st neutropenia
date
C0027947 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing adverse event, neutropenia
Item
1st neutropenia ongoing at start administration Cytarabin /Induction II??
boolean
C0027947 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Ongoing adverse event, neutropenia
Item
1st neutropenia ongoing at this visit ?
boolean
C0027947 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, neutropenia
Item
End date 1st neutropenia
date
C0027947 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Second onset neutropenia
Item
Second onset neutropenia?
boolean
C0027947 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
Neutropenia onset date
Item
Date of 2nd onset of neutropenia
date
C0027947 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing Adverse event , neutropenia
Item
2nd neutropenia ongoing at this visit ?
boolean
C0027947 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, neutropenia
Item
End date 2nd neutropenia
date
C0027947 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Thrombopenia grade IV
Item
Thrombopenia grade IV
boolean
C0040034 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Preexisting Thrombopenia
Item
1st Thrombopenia preexisting at V1?
boolean
C0040034 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Thrombopenia onset date
Item
Date of onset of 1st Thrombopenia
date
C0040034 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing adverse event, Thrombopenia
Item
1st Thrombopenia ongoing at start administration Cytarabin /Induction II??
boolean
C0040034 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Ongoing adverse event, Thrombopenia
Item
1st Thrombopenia ongoing at this visit ?
boolean
C0040034 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, neutropenia
Item
End date 1st neutropenia
date
C0027947 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Second onset Thrombopenia
Item
Second onset Thrombopenia?
boolean
C0040034 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
Thrombopenia onset date
Item
Date of 2nd onset of Thrombopenia
date
C0040034 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Ongoing Adverse event , Thrombopenia
Item
2nd Thrombopenia ongoing at this visit ?
boolean
C0040034 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Adverse event end date, Thrombopenia
Item
End date 2nd Thrombopenia
date
C0040034 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
RBC transfusion units
Item
Number of RBC transfusion units from start trial until this visit
integer
C0086252 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
platelet transfusion units
Item
Number of platelet transfusion units from start trial until this visit
integer
C0086818 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
Item
G-CSF administered during trial?
integer
C0079459 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Code List
G-CSF administered during trial?
G-CSF start date
Item
Start date 1st administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
G-CSF end date
Item
End date 1st administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
G-CSF ongoing
Item
1st administration ongoing at this visit
boolean
C0079459 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
G-CSF administered during trial?
integer
C0079459 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Code List
G-CSF administered during trial?
G-CSF start date
Item
Start date 1st administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
G-CSF end date
Item
End date 1st administration G-CSF
date
C0079459 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
G-CSF ongoing
Item
1st administration ongoing at this visit
boolean
C0079459 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Response Assessment
integer
C0521982 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Code List
Response Assessment
CL Item
Done (1)
C1272695 (UMLS CUI-1)
(Comment:en)
CL Item
Not done (2)
C1272696 (UMLS CUI-1)
(Comment:en)
CL Item
Failed (3)
C1272705 (UMLS CUI-1)
(Comment:en)
Bone marrow aspiration or biopsy date
Item
Date of aspiration or biopsy
date
C0005954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0398523 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Percentage of blasts
Item
Percentage of blasts
float
C0587348 (UMLS CUI [1])
Item
Remission Assessment
integer
C0544452 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Code List
Remission Assessment
CL Item
Neither aspirate nor biopsy done (2)
Bone marrow aspiration or biopsy date
Item
Date of aspiration or biopsy
date
C0005954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0398523 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item
Cytogenetics analysis
integer
C0752095 (UMLS CUI [1])
Code List
Cytogenetics analysis
CL Item
Failed (e.g. technical problems, EDTA conditioned) (2)
CL Item
Failure (bad morphology, no proliferation) (3)
Number of analyzed metaphases
Item
Total Number of analyzed metaphases
integer
C1621812 (UMLS CUI [1,1])
C0260877 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item
Karyotype
integer
C1261273 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
CL Item
Normal karyotype (1)
CL Item
Abnormal karyotype (2)
Item
If karyotype is not normal, which characteristics apply?
integer
C1261273 (UMLS CUI [1,1])
C0008625 (UMLS CUI [1,2])
Code List
If karyotype is not normal, which characteristics apply?
CL Item
high risk aberrations (1)
CL Item
low risk aberrations (2)
Complete
Item
Have you marked all karyotype characteristics?
boolean
C0205197 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Item
High risk aberrations
integer
C0008625 (UMLS CUI [1,1])
C0684030 (UMLS CUI [1,2])
Code List
High risk aberrations
CL Item
-5 (1)
C0439075 (UMLS CUI-1)
(Comment:en)
CL Item
-7 (2)
C3846158 (UMLS CUI-1)
(Comment:en)
CL Item
abnl(17p) (3)
C0796349 (UMLS CUI-1)
(Comment:en)
CL Item
del(5q) (4)
C1521461 (UMLS CUI-1)
(Comment:en)
CL Item
inv(3)(q21q26.2) (5)
C1515666 (UMLS CUI-1)
(Comment:en)
CL Item
t(3;3)(q21;q26.2) (6)
C1515764 (UMLS CUI-1)
(Comment:en)
CL Item
t(6;9) (q23;q34) (7)
C1515781 (UMLS CUI-1)
(Comment:en)
CL Item
t(v;11)(v;q23) (8)
C1515810 (UMLS CUI-1)
(Comment:en)
CL Item
complex karyotype (≥ 3 aberrations) (9)
C3273253 (UMLS CUI-1)
(Comment:en)
Item
Low risk aberrations
integer
C0008625 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
Code List
Low risk aberrations
CL Item
inv(16) (1)
C3897144 (UMLS CUI-1)
(Comment:en)
CL Item
t(8;21) (2)
C3897139 (UMLS CUI-1)
(Comment:en)
CL Item
t(16;16) (3)
C4287945 (UMLS CUI-1)
(Comment:en)
CL Item
other aberrations (4)
C0008625 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
Other aberrations
Item
Other aberrations, please specify
text
C0008625 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Further entry
Item
Further entry
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])