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
Physical Examination
integer
C0031809 (UMLS CUI [1])
Code List
Physical Examination
Item
General Appearance
integer
C1148438 (UMLS CUI [1])
Code List
General Appearance
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
General Appearance findings
Item
General Appearance: In case of significant findings, please specify
text
C1148438 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Nervous system
integer
C0027763 (UMLS CUI [1])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Nervous system findings
Item
Nervous system: In case of significant findings, please specify
text
C0027763 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Lungs
integer
C2228454 (UMLS CUI [1])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Examination of Lungs findings
Item
Lungs: In case of significant findings, please specify
text
C2228454 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Heart
integer
C0562319 (UMLS CUI [1])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Heart findings
Item
Heart: In case of significant findings, please specify
text
C0562319 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Abdomen
integer
C0562238 (UMLS CUI [1])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Abdominal findings
Item
Abdomen: In case of significant findings, please specify
text
C0562238 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Head examination
integer
C2239107 (UMLS CUI [1])
Code List
Head examination
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Head examination findings
Item
Head: In case of significant findings, please specify
text
C2239107 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Neck including Thyroid
integer
Code List
Neck including Thyroid
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Neck and thyroid examination findings
Item
Neck including Thyroid: In case of significant findings, please specify
text
C2228463 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2228489 (UMLS CUI [2,1])
C2607943 (UMLS CUI [2,2])
Item
Skin
integer
C0436149 (UMLS CUI [1])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Skin examination findings
Item
Skin: In case of significant findings, please specify
text
C0436149 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Extremities examination
integer
C0436150 (UMLS CUI [1])
Code List
Extremities examination
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Extremities examination findings
Item
Extremities: In case of significant findings, please specify
text
C0436150 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Signs of bleeding
integer
C3251812 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
Code List
Signs of bleeding
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
Signs of bleeding findings
Item
Signs of bleeding: In case of significant findings, please specify
text
C3251812 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Item
Lymph nodes
integer
C0562297 (UMLS CUI [1])
CL Item
Done and no lymphadenopathy palpable (1)
CL Item
Done and lymphadenopathy palpable (2)
Lymph nodes examination findings
Item
Lymph nodes: Description of manifestations
text
C0562297 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
Lymph node size
Item
Length of largest lymph node
integer
C1285847 (UMLS CUI [1,1])
C0443228 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
Lymph node size
Item
Width of largest lymph node
integer
C1285847 (UMLS CUI [1,1])
C0443228 (UMLS CUI [1,2])
C0487742 (UMLS CUI [1,3])
Item
Full blood count
integer
C0005771 (UMLS CUI [1])
Code List
Full blood count
Date of sampling
Item
Date of sampling
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Leukocytes
Item
Leukocytes Value
integer
C0023508 (UMLS CUI [1])
Item
Unit for leukocytes
integer
C1519795 (UMLS CUI [1])
Code List
Unit for leukocytes
CL Item
Gpt/l (=10^9/l = /nl) (1)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Haemoglobin
Item
Haemoglobin value
integer
C0518015 (UMLS CUI [1])
Item
Unit for Haemoglobin
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Haemoglobin
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Platelets
Item
Platelets value
integer
C0032181 (UMLS CUI [1])
Item
Unit for Platelets
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Platelets
CL Item
Gpt/l (=10^9/l = /nl) (1)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Neutrophiles
Item
Neutrophiles value
integer
C0200633 (UMLS CUI [1])
Item
Unit for Neutrophiles
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Neutrophiles
CL Item
Gpt/l (=10^9/l = /nl) (1)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Lymphocytes
Item
Lymphocytes value
integer
C0200635 (UMLS CUI [1])
Item
Unit for Lymphocytes
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Lymphocytes
CL Item
Gpt/l (=10^9/l = /nl) (1)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Monocytes
Item
Monocytes value
integer
C0200637 (UMLS CUI [1])
Item
Unit for Monocytes
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Monocytes
CL Item
Gpt/l (=10^9/l = /nl) (1)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Basophiles
Item
Basophiles value
integer
C0200641 (UMLS CUI [1])
Item
Unit for Basophiles
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Basophiles
CL Item
Gpt/l (=10^9/l = /nl) (1)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Eosinophiles
Item
Eosinophiles value
integer
C0750879 (UMLS CUI [1])
Item
Unit for Eosinophiles
integer
Code List
Unit for Eosinophiles
CL Item
Gpt/l (=10^9/l = /nl) (1)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Blast percentage
Item
Percentage of blasts in pB
integer
C0587348 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Item
Clinical Chemistry
integer
C0008000 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Clinical Chemistry
Date of sampling
Item
Date of sampling
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
AST (GOT)
Item
AST (GOT) value
float
C0201899 (UMLS CUI [1])
Item
Units for AST (GOT)
integer
C1519795 (UMLS CUI [1])
Code List
Units for AST (GOT)
CL Item
μmol/s*l (μkat/l) (2)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
ALT (GPT)
Item
ALT (GPT) value
float
C0201836 (UMLS CUI [1])
Item
Units for ALT (GPT)
integer
C1519795 (UMLS CUI [1])
Code List
Units for ALT (GPT)
CL Item
μmol/s*l (μkat/l) (2)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Bilirubin
Item
Bilirubin (total) value
float
C1278039 (UMLS CUI [1])
Item
Units for Bilirubin
integer
C1519795 (UMLS CUI [1])
Code List
Units for Bilirubin
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Creatinine
Item
Creatinine value
float
C0201976 (UMLS CUI [1])
Item
Units for Creatinine
integer
C1519795 (UMLS CUI [1])
Code List
Units for Creatinine
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Sodium
Item
Sodium value
float
C0337443 (UMLS CUI [1])
Item
Units for Sodium
integer
C1519795 (UMLS CUI [1])
Code List
Units for Sodium
CL Item
mEq/l (mval/l) (2)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Potassium
Item
Potassium value
float
C0202194 (UMLS CUI [1])
Item
Units for Potassium
integer
C1519795 (UMLS CUI [1])
Code List
Units for Potassium
CL Item
mEq/l (mval/l) (2)
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Item
Coagulation
integer
C0005790 (UMLS CUI [1])
Date of sampling
Item
Date of sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
PTT
Item
PTT (partial thromboplastin time) value
integer
C0030605 (UMLS CUI [1])
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
INR
Item
INR Value
float
C0525032 (UMLS CUI [1])
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Fibrinogen
Item
Fibrinogen value
float
C0337428 (UMLS CUI [1])
Item
Units for Fibrinogen
integer
C1519795 (UMLS CUI [1])
Code List
Units for Fibrinogen
Item
Value is
integer
C2826293 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
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
C0522055 (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)
Item
Extramedullary Manifestations assessment
integer
C1868812 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Code List
Extramedullary Manifestations assessment
CL Item
Yes, histologically proven (3)
Extramedullary Manifestations anatomic site
Item
If yes or suspected, location
text
C1868812 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
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
Remission Assessment
integer
C0544452 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Code List
Remission Assessment
CL Item
Done (1)
C1272695 (UMLS CUI-1)
(Comment:en)
CL Item
Neither aspirate nor biopsy done (2)
C0857285 (UMLS CUI-1)
C1272696 (UMLS CUI-2)
C0005954 (UMLS CUI-3)
C1272696 (UMLS CUI-4)
(Comment:en)
CL Item
No assessment of extracted bone marrow possible (3)
C2238269 (UMLS CUI-1)
C1272705 (UMLS CUI-2)
(Comment:en)
Bone Marrow biopsy date
Item
Date of aspiration or biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
Percentage of blasts
Item
Percentage of blasts (Local)
float
C0587348 (UMLS CUI [1])
Item
Bone Marrow assessment
integer
C0005957 (UMLS CUI [1])
Code List
Bone Marrow assessment
CL Item
assessed by cytology (1)
CL Item
assessed by histology (2)
Percentage of blasts
Item
Percentage of blasts (central, assessed by cytology)
float
C0587348 (UMLS CUI [1,1])
C1305671 (UMLS CUI [1,2])
Molecular genetics
Item
Molecular genetics not done or failed
boolean
C0086345 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0086345 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Item
RUNX1-RUNX1 T1
integer
C1851466 (UMLS CUI [1])
CL Item
Not done/failed (3)
Item
CBF/MYH11
integer
C3276534 (UMLS CUI [1])
CL Item
Not done/failed (3)
Item
Bcr-Abl 1
integer
C1835417 (UMLS CUI [1])
CL Item
Not done/failed (3)
Item
NPM1-Mut
integer
C2826175 (UMLS CUI [1])
CL Item
Not done/failed (3)
Item
CEBPA-Mut
integer
C1511473 (UMLS CUI [1])
CL Item
Not done/failed (3)
Item
FLT3-ITD-Mut
integer
C2348499 (UMLS CUI [1])
CL Item
Not done/failed (3)
Item
FLT3-ITD/wt ratio
integer
C2348499 (UMLS CUI [1,1])
C0216388 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
Code List
FLT3-ITD/wt ratio
CL Item
Not done/failed (3)
Item
Other
integer
C0026882 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
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)
C1515714 (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])
Item
Extramedullary Manifestations assessment
integer
C1868812 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Code List
Extramedullary Manifestations assessment
CL Item
Yes, histologically proven (3)
Extramedullary Manifestations anatomic site
Item
If yes or suspected, location
text
C1868812 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Item
According to study protocol the treatment was
integer
C1516048 (UMLS CUI [1,1])
C0679864 (UMLS CUI [1,2])
Code List
According to study protocol the treatment was
CL Item
a success (blast count (local assessment) < 5%) (1)
CL Item
a failure (failure: blast count >= 5 %, no assessment of extracted bone marrow possible, neither aspiration nor biopsy of bone marrow done, drop out be-fore bone marrow assessment at visit 7 including death) (2)