Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient data
C2707520 (UMLS CUI 2011AB)
MTHU031990 (LOINC Version 232)
Pat. No.
Item
Pat. No.: -
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Item Group
Clinical finding
C0037088 (UMLS CUI 2011AB)
404684003 (SNOMEDCT_2012_01_31)
Physical Examination Date
Item
Physical Examination Date:
date
C2826643 (UMLS CUI 2011AB)
Item
ECOG performance status finding:
integer
C1828127 (UMLS CUI 2011AB)
424122007 (SNOMEDCT_2012_01_31)
Code List
ECOG performance status finding:
CL Item
ECOG 0 (Normal physical fitness) (0)
C1828078 (UMLS CUI 2011AB)
425389002 (SNOMEDCT_2012_01_31)
CL Item
ECOG 1 (Outpatient care, easy work possible) (1)
C1827388 (UMLS CUI 2011AB)
422512005 (SNOMEDCT_2012_01_31)
CL Item
ECOG 2 (Less than half day bed-ridden, self-sufficiency possible, but not able to work) (2)
C1828242 (UMLS CUI 2011AB)
422894000 (SNOMEDCT_2012_01_31)
CL Item
ECOG 3 (More than half day bed-ridden, limited self-sufficiency possible) (3)
C1827126 (UMLS CUI 2011AB)
423053003 (SNOMEDCT_2012_01_31)
CL Item
ECOG 4 (Permanent bed-ridden) (4)
C1827528 (UMLS CUI 2011AB)
423237006 (SNOMEDCT_2012_01_31)
Weight
Item
Body weight
float
Body Weight (Code-1)
27113001 (SNOMEDCT_2012_01_31)
MTHU001885 (LOINC Version 232)
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
Body Surface Area (Code-1)
301898006 (SNOMEDCT_2012_01_31)
10050311 (MedDRA 14.1)
C0005902 (UMLS CUI [1])
Item Group
Differential blood count
Differential Leukocyte Count (Code-1)
C0162401 (UMLS CUI 2011AB)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Differential Leukocyte Count (Code-2)
C0162401 (UMLS CUI 2011AB)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
Hemoglobin
Item
Hemoglobin
float
Hemoglobin (Code-1)
10018876 (MedDRA 14.1)
C0019046 (UMLS CUI [1])
Leukocytes
Item
Leukocytes
float
Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
26464-8 (LOINC Version 232)
C0023516 (UMLS CUI [1])
Prozentanteil Neutrophile
Item
Neutrophil percentage
integer
Neutrophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942471 (UMLS CUI 2011AB)
26511-6 (LOINC Version 232)
Prozentanteil Stabkernige
Item
Band neutrophil percentage
integer
Neutrophils.band form/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942468 (UMLS CUI 2011AB)
26508-2 (LOINC Version 232)
[oder] Prozentanteil Segmentkernige
Item
[or] Segmented neutrophil percentage
integer
Neutrophils.segmented/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942466 (UMLS CUI 2011AB)
26505-8 (LOINC Version 232)
Prozentanteil Lymphozyten
Item
Lymphocyte percentage
integer
Lymphocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942440 (UMLS CUI 2011AB)
26478-8 (LOINC Version 232)
Prozentanteil Monozyten
Item
Monocyte percentage
integer
Monocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942447 (UMLS CUI 2011AB)
26485-3 (LOINC Version 232)
Prozentanteil Eosinophile
Item
Eosinophil percentage
integer
Eosinophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0945354 (UMLS CUI 2011AB)
26450-7 (LOINC Version 232)
Prozentanteil Basophile
Item
Basophil percentage
integer
Basophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C1114065 (UMLS CUI 2011AB)
30180-4 (LOINC Version 232)
Prozentanteil Blasten
Item
Blast cell percentage
integer
Blasts/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942416 (UMLS CUI 2011AB)
26446-5 (LOINC Version 232)
Prozentanteil Promyelozyten
Item
Promyelocyte percentage
integer
Promyelocytes/100 leukocytes:Number Fraction:Point in time:Whole blood:Quantitative (Code-1)
C1114906 (UMLS CUI 2011AB)
26524-9 (LOINC Version 232)
Prozentanteil Myelozyten
Item
Myelocyte percentage
integer
Myelocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942460 (UMLS CUI 2011AB)
26498-6 (LOINC Version 232)
Prozentanteil Metamyelozyten
Item
Metamyelocyte percentage
integer
Metamyelocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0944135 (UMLS CUI 2011AB)
28541-1 (LOINC Version 232)
Prozentanteil sonstige Zellen
Item
Percentage of other cells
integer
Other cells/100 leukocytes (Code-1)
C1978275 (UMLS CUI 2011AB)
MTHU026796 (LOINC Version 232)
Platelets
Item
Peripheral Platelet Count
float
Platelets:NCnc:Pt:Bld:Qn (Code-1)
26515-7 (LOINC Version 232)
C0005821 (UMLS CUI [1])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Sodium
Item
Sodium
float
Sodium:SCnc:Pt:Bld:Qn (Code-1)
2947-0 (LOINC Version 232)
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
Potassium:SCnc:Pt:Bld:Qn (Code-1)
6298-4 (LOINC Version 232)
C0202194 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
Total Protein Measurement (Code-1)
304383000 (SNOMEDCT_2012_01_31)
10050537 (MedDRA 14.1)
C0036836 (UMLS CUI [1])
Uric acid
Item
Uric acid
float
Urate [Mass/volume] in Serum or Plasma (Code-1)
3084-1 (LOINC Version 232)
C0041980 (UMLS CUI [1])
BUN
Item
BUN
float
Urea Measurement (Code-1)
105010007 (SNOMEDCT_2012_01_31)
10046346 (MedDRA 14.1)
C0005845 (UMLS CUI [1])
Creatinine, Serum
Item
Creatinine
float
Creatinine Measurement (Code-1)
70901006 (SNOMEDCT_2012_01_31)
10005480 (MedDRA 14.1)
C0201976 (UMLS CUI [1])
Bilirubin, total
Item
Bilirubin, total
float
Total Bilirubin Measurement (Code-1)
359986008 (SNOMEDCT_2012_01_31)
10004696 (MedDRA 14.1)
C0201913 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
Aspartate transaminase level (Code-1)
373679006 (SNOMEDCT_2012_01_31)
C0201899 (UMLS CUI [1])
ALT
Item
ALT (SGPT)
float
Alanine Transaminase (Code-1)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
Alkaline phosphatase level - finding (Code-1)
365771003 (SNOMEDCT_2012_01_31)
C0201850 (UMLS CUI [1])
LDH
Item
Lactate Dehydrogenase
float
Lactate Dehydrogenase (Code-1)
259319003 (SNOMEDCT_2012_01_31)
MTHU002348 (LOINC Version 232)
C0202113 (UMLS CUI [1])
CRP
Item
CRP
float
C-reactive protein (Code-1)
61425002 (SNOMEDCT_2012_01_31)
MTHU002335 (LOINC Version 232)
C0201657 (UMLS CUI [1])
Quick
Item
Quick
float
Prothrombin time ratio (Code-1)
10037064 (MedDRA 14.1)
C0483455 (UMLS CUI [1])
INR
Item
INR
float
International Normalized Ratio (Code-1)
C0525032 (UMLS CUI [1])
PTT
Item
PTT
float
Activated Partial Thromboplastin Time measurement (Code-1)
42525009 (SNOMEDCT_2012_01_31)
10000630 (MedDRA 14.1)
C0030605 (UMLS CUI [1])
Item
Patient randomization in study arm:
integer
Protocol Treatment Arm (Code-1)
C1522541 (UMLS CUI 2011AB)
Code List
Patient randomization in study arm:
CL Item
A (5-Azacytidine) (1)
A (Code-1)
C1706281 (UMLS CUI 2011AB)
422097006 (SNOMEDCT_2012_01_31)
5-Azacytidine (Code-2)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
CL Item
B (Documentation continued on page 31) (2)
B (Code-1)
C0439105 (UMLS CUI 2011AB)
421151005 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Item
5-Azacytidine dose:
integer
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Code List
5-Azacytidine dose:
CL Item
DL 0: 18 mg/m2 (0)
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Level (Code-2)
C0456079 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Zero (Code-3)
C0919414 (UMLS CUI 2011AB)
258317007 (SNOMEDCT_2012_01_31)
Eight (Code-4)
C0205454 (UMLS CUI 2011AB)
421825006 (SNOMEDCT_2012_01_31)
Ten (Code-5)
C0205456 (UMLS CUI 2011AB)
420258001 (SNOMEDCT_2012_01_31)
mg/m2 (Code-6)
C1319266 (UMLS CUI 2011AB)
396174004 (SNOMEDCT_2012_01_31)
CL Item
DL 1: 37,5 mg/m2 (1)
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Level (Code-2)
C0456079 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
One (Code-3)
C0205447 (UMLS CUI 2011AB)
421379005 (SNOMEDCT_2012_01_31)
Thirty (Code-4)
CL447153 (UMLS CUI 2011AB)
Seven (Code-5)
C0205453 (UMLS CUI 2011AB)
420359007 (SNOMEDCT_2012_01_31)
Point (Code-6)
CL415149 (UMLS CUI 2011AB)
CL Item
DL 2: 75 mg/m2 (2)
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Level (Code-2)
C0456079 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Seventy (Code-4)
CL447148 (UMLS CUI 2011AB)
Five (Code-5)
C0205451 (UMLS CUI 2011AB)
421820001 (SNOMEDCT_2012_01_31)
mg/m2 (Code-6)
C1319266 (UMLS CUI 2011AB)
396174004 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 1
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-3)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-3)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
First (Code-3)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Code List
Route of administration
CL Item
subcutaneous (1)
Subcutaneous Route of Drug Administration (Code-1)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Reason for not subcutaneous
Item
Reason for not subcutaneous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Subcutaneous Route of Drug Administration (Code-2)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 2
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-3)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-3)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-5)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Second (Code-3)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-5)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Code List
Route of administration
CL Item
subcutaneous (1)
Subcutaneous Route of Drug Administration (Code-1)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Reason for not subcutaneous
Item
Reason for not subcutaneous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Subcutaneous Route of Drug Administration (Code-2)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 3
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-3)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-3)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-5)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Third (Code-3)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-5)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Code List
Route of administration
CL Item
subcutaneous (1)
Subcutaneous Route of Drug Administration (Code-1)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Reason for not subcutaneous
Item
Reason for not subcutaneous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Subcutaneous Route of Drug Administration (Code-2)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 4
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-3)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-3)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-5)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Fourth (Code-3)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-5)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Code List
Route of administration
CL Item
subcutaneous (1)
Subcutaneous Route of Drug Administration (Code-1)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Reason for not subcutaneous
Item
Reason for not subcutaneous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Subcutaneous Route of Drug Administration (Code-2)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 5
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-3)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-3)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-5)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Fifth (Code-3)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-5)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Code List
Route of administration
CL Item
subcutaneous (1)
Subcutaneous Route of Drug Administration (Code-1)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Reason for not subcutaneous
Item
Reason for not subcutaneous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Subcutaneous Route of Drug Administration (Code-2)
C1522438 (UMLS CUI 2011AB)
34206005 (SNOMEDCT_2012_01_31)
_SubcutaneousRoute (HL7 V3 2006_05)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine dose reduction
Dose Reduced (Code-1)
C1707814 (UMLS CUI 2011AB)
5-Azacytidine (Code-2)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
5-Azacytidine dose reduction
Item
5-Azacytidine dose reduction
boolean
Dose Reduced (Code-1)
C1707814 (UMLS CUI 2011AB)
5-Azacytidine (Code-2)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Item
yes, reason:
integer
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
CL Item
AE(s) in actual therapy block (1)
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Actual (Code-2)
C0237400 (UMLS CUI 2011AB)
Therapy (Code-3)
C0039798 (UMLS CUI 2011AB)
Block (Code-4)
C2828370 (UMLS CUI 2011AB)
CL Item
AE(s) in a previous therapy block (2)
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Previous (Code-2)
C0205156 (UMLS CUI 2011AB)
9130008 (SNOMEDCT_2012_01_31)
Therapy (Code-3)
C0039798 (UMLS CUI 2011AB)
Block (Code-4)
C2828370 (UMLS CUI 2011AB)
CL Item
treatment error (3)
treatment error (Code-1)
C0679862 (UMLS CUI 2011AB)
CL Item
Miscellaneous (4)
C0205395 (UMLS CUI 2011AB)
49634009 (SNOMEDCT_2012_01_31)
MTHU000097 (LOINC Version 232)
Miscellaneous
Item
Miscellaneous:
string
C0205395 (UMLS CUI 2011AB)
49634009 (SNOMEDCT_2012_01_31)
MTHU000097 (LOINC Version 232)
Free Text Format (Code-2)
C2348713 (UMLS CUI 2011AB)
AE-No
Item
AE-No:
integer
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Number (Code-2)
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
Actual (Code-3)
C0237400 (UMLS CUI 2011AB)
Therapy (Code-4)
C0039798 (UMLS CUI 2011AB)
Block (Code-5)
C2828370 (UMLS CUI 2011AB)
AE-No
Item
AE-No:
integer
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Number (Code-2)
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
Previous (Code-3)
C0205156 (UMLS CUI 2011AB)
9130008 (SNOMEDCT_2012_01_31)
Therapy (Code-4)
C0039798 (UMLS CUI 2011AB)
Block (Code-5)
C2828370 (UMLS CUI 2011AB)
Item Group
Transfusions
C1879316 (UMLS CUI 2011AB)
5447007 (SNOMEDCT_2012_01_31)
10066152 (MedDRA 14.1)
Transfusions between day 1 of 1st consolidation chemotherapy and day 1 of 2nd consolidation chemotherapy
Item
How many transfusions did the patient receive in the period between day 1 of the 1st consolidation chemotherapy AND day 1 of the 2nd consolidation chemotherapy?
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Transfusions (Code-2)
C1879316 (UMLS CUI 2011AB)
5447007 (SNOMEDCT_2012_01_31)
10066152 (MedDRA 14.1)
Between (Code-3)
CL426201 (UMLS CUI 2011AB)
day (Code-4)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
D (HL7 V3 2006_05)
1 (Code-5)
C0205447 (UMLS CUI 2011AB)
38112003 (SNOMEDCT_2012_01_31)
1st (Code-6)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Number of transfused erythrocyte concentrates
Item
Number of transfused erythrocyte concentrates:
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Erythrocyte Transfusion (Code-2)
C0086252 (UMLS CUI 2011AB)
116863004 (SNOMEDCT_2012_01_31)
Concentrate (Code-3)
C2003864 (UMLS CUI 2011AB)
Number of transfused platelet concentrates
Item
Number of transfused platelet concentrates:
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Platelet transfusion (Code-2)
C0086818 (UMLS CUI 2011AB)
12719002 (SNOMEDCT_2012_01_31)
10035543 (MedDRA 14.1)
99.05 (ICD-9-CM Version 2011)
Concentrate (Code-3)
C2003864 (UMLS CUI 2011AB)
Item Group
Chemotherapy
C0392920 (UMLS CUI 2011AB)
150415003 (SNOMEDCT_2012_01_31)
Day 1
Item
Day 1:
date
day (Code-1)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
D (HL7 V3 2006_05)
1 (Code-2)
C0205447 (UMLS CUI 2011AB)
38112003 (SNOMEDCT_2012_01_31)
Item Group
Ara-C (2 x 1g/sqm over 3 hrs intravenous day 1,3,5)
Ara-C (Code-1)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
2 x (Code-2)
C1948050 (UMLS CUI 2011AB)
1 (Code-3)
C0205447 (UMLS CUI 2011AB)
38112003 (SNOMEDCT_2012_01_31)
g/m2 (Code-4)
C1300564 (UMLS CUI 2011AB)
396168004 (SNOMEDCT_2012_01_31)
3 (Code-5)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
h (Code-6)
C0439227 (UMLS CUI 2011AB)
258702006 (SNOMEDCT_2012_01_31)
Ara-C - dose reduction
Item
Ara-C - dose reduction
boolean
Ara-C (Code-1)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Dose Reduced (Code-2)
C1707814 (UMLS CUI 2011AB)
Reason
Item
(if yes:) a) Reason:
string
Reason (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Ara-C (Code-2)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Dose Reduced (Code-3)
C1707814 (UMLS CUI 2011AB)
Absolute total dose
Item
(if yes:) b) Absolute total dose in this therapy block (mg):
integer
Absolute (Code-1)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
Total Dose (Code-2)
C2986497 (UMLS CUI 2011AB)
Therapy (Code-3)
C0039798 (UMLS CUI 2011AB)
Block (Code-4)
C2828370 (UMLS CUI 2011AB)
mg (Code-5)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Ara-C (Code-6)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Item Group
G-CSF dose
G-CSF (Code-1)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Patient did receive G-CSF
Item
Patient did receive G-CSF:
boolean
Patient (Code-1)
C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
Receive (Code-2)
C1514756 (UMLS CUI 2011AB)
G-CSF (Code-3)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
Begin
Item
(if yes:) Start date:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
G-CSF (Code-2)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
End
Item
(if yes:) End date:
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
G-CSF (Code-2)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
Item
(if yes:) Pharmaceutical Preparations:
integer
C0013227 (UMLS CUI 2011AB)
MTHU038481 (LOINC Version 232)
Code List
(if yes:) Pharmaceutical Preparations:
CL Item
Neulasta (1)
C1171279 (UMLS CUI 2011AB)
388379009 (SNOMEDCT_2012_01_31)
CL Item
Neupogen (2)
C0210630 (UMLS CUI 2011AB)
108965009 (SNOMEDCT_2012_01_31)
CL Item
Granocyte (3)
C0218640 (UMLS CUI 2011AB)
327123007 (SNOMEDCT_2012_01_31)
CL Item
other (4)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Item Group
Cytopenia duration
Cytopenia (Code-1)
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
Duration (Code-2)
C0449238 (UMLS CUI 2011AB)
103335007 (SNOMEDCT_2012_01_31)
MTHU001938 (LOINC Version 232)
Item Group
leucocytes <1,0 GPt/l or <1000 /ul
Leukocytes (Code-1)
C0023516 (UMLS CUI 2011AB)
52501007 (SNOMEDCT_2012_01_31)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)
Less Than (Code-2)
C0439092 (UMLS CUI 2011AB)
Thousand Cells per Microliter (Code-3)
C1883312 (UMLS CUI 2011AB)
One (Code-4)
C0205447 (UMLS CUI 2011AB)
421379005 (SNOMEDCT_2012_01_31)
Billion Cells per Liter (Code-5)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
start leukopenia
Item
Start date (leucocytes <1,0 GPt/l or <1000 /ul)
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Leukopenia (Code-2)
C0023530 (UMLS CUI 2011AB)
D72.81 (ICD-10-CM Version 2010)
288.5 (ICD-9-CM Version 2011)
end leukopenia
Item
End date (leucocytes >=1,0 GPt/l or >=1000 /ul)
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Leukopenia (Code-2)
C0023530 (UMLS CUI 2011AB)
D72.81 (ICD-10-CM Version 2010)
288.5 (ICD-9-CM Version 2011)
Ongoing cytopenia
Item
(or) cytopenia ongoing [leucocytes <1,0 GPt/l or <1000 /ul] on:
date
Leukopenia (Code-1)
C0023530 (UMLS CUI 2011AB)
D72.81 (ICD-10-CM Version 2010)
288.5 (ICD-9-CM Version 2011)
ongoing (Code-2)
C0750536 (UMLS CUI 2011AB)
Item Group
neutrophils <0,5 GPt/l or <500 /ul
Neutrophils (Code-1)
C0027950 (UMLS CUI 2011AB)
116712007 (SNOMEDCT_2012_01_31)
10029380 (MedDRA 14.1)
MTHU006207 (LOINC Version 232)
Less Than (Code-2)
C0439092 (UMLS CUI 2011AB)
Five (Code-3)
C0205451 (UMLS CUI 2011AB)
421820001 (SNOMEDCT_2012_01_31)
One Hundred (Code-4)
CL447292 (UMLS CUI 2011AB)
Thousand Cells per Microliter (Code-5)
C1883312 (UMLS CUI 2011AB)
Half (Code-6)
C2825407 (UMLS CUI 2011AB)
start neutropenia
Item
Start date (neutrophils <0,5 GPt/l or <500 /ul)
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Neutropenia (Code-2)
C0027947 (UMLS CUI 2011AB)
165517008 (SNOMEDCT_2012_01_31)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288 (ICD-9-CM Version 2011)
end neutropenia
Item
End date (neutrophils >=0,5 GPt/l or >=500 /ul)
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Neutropenia (Code-2)
C0027947 (UMLS CUI 2011AB)
165517008 (SNOMEDCT_2012_01_31)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288 (ICD-9-CM Version 2011)
Ongoing cytopenia
Item
(or) cytopenia ongoing [neutrophils <0,5 GPt/l or <500 /ul] on:
date
Neutropenia (Code-1)
C0027947 (UMLS CUI 2011AB)
165517008 (SNOMEDCT_2012_01_31)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288.00 (ICD-9-CM Version 2011)
ongoing (Code-2)
C0750536 (UMLS CUI 2011AB)
Item Group
Start date (platelets <25 GPt/l or <25000 /ul)
platelets (Code-1)
C0005821 (UMLS CUI 2011AB)
16378004 (SNOMEDCT_2012_01_31)
MTHU002432 (LOINC Version 232)
Less Than (Code-2)
C0439092 (UMLS CUI 2011AB)
Twenty (Code-3)
CL447287 (UMLS CUI 2011AB)
Five (Code-4)
C0205451 (UMLS CUI 2011AB)
421820001 (SNOMEDCT_2012_01_31)
Thousand Cells per Microliter (Code-5)
C1883312 (UMLS CUI 2011AB)
Twenty (Code-6)
CL447287 (UMLS CUI 2011AB)
start thrombopenia
Item
Start date (platelets <25 GPt/l or <25000 /ul)
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Thrombocytopenia (Code-2)
C0040034 (UMLS CUI 2011AB)
415116008 (SNOMEDCT_2012_01_31)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
end thrombopenia
Item
End date (platelets >=25 GPt/l or >=25000 /ul - increasing, independent of substitution of platelets)
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Thrombocytopenia (Code-2)
C0040034 (UMLS CUI 2011AB)
415116008 (SNOMEDCT_2012_01_31)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
Ongoing cytopenia
Item
(or) cytopenia ongoing [platelets <25 GPt/l or <25000 /ul] on:
date
Thrombocytopenia (Code-1)
C0040034 (UMLS CUI 2011AB)
415116008 (SNOMEDCT_2012_01_31)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
ongoing (Code-2)
C0750536 (UMLS CUI 2011AB)
Item Group
Signature
C1519316 (UMLS CUI 2011AB)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Name/Unterschrift Prüfarzt
Item
Name/Signature study physician
string
Name (Code-1)
C0027365 (UMLS CUI 2011AB)
MTHU008539 (LOINC Version 232)
Signature (Code-2)
C1519316 (UMLS CUI 2011AB)
Study (Code-3)
C0008976 (UMLS CUI 2011AB)
110465008 (SNOMEDCT_2012_01_31)
Physician (Code-4)
C0031831 (UMLS CUI 2011AB)
309343006 (SNOMEDCT_2012_01_31)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)