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])
Lost to follow up
Item
Visit 7 not done
boolean
C1302313 (UMLS CUI [1])
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)
Hemoglobin
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
C1519795 (UMLS CUI [1])
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
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)
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)
FLT3-ITD/wt ratio
Item
FLT3-ITD/wt ratio
text
C2348499 (UMLS CUI [1,1])
C0216388 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
Item
Other
integer
C0026882 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other
Item
If other, please specify
text
C0026882 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
According to study protocol the treatment was
text
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
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) (a failure (failure: blast count >)