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)