ID

42904

Descrizione

http://clinicaltrials.gov/ct2/show/NCT01657604

collegamento

http://clinicaltrials.gov/ct2/show/NCT01657604

Keywords

versioni (2)
  1. 18/01/14 18/01/14 -
  2. 17/09/21 17/09/21 -
Caricato su

17 settembre 2021

DOI

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Licenza

Creative Commons BY 4.0
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Einschlusskriterien DRKS00005243 NCT01657604 Chronic Myeloid Leukemia

Tedesco Inglese

Einschlusskriterien

1 moduli  
  1. StudyEvent: Chronic Myeloid Leukemia
    1. Einschlusskriterien
Administrative Items
Descrizione

Administrative Items

Alias
Code-1
Administrative Items
UMLS CUI 2011AB
C2598108
LOINC Version 232
MTHU029788
Hospital Identifier
Descrizione

Klinik-Nr.

Tipo di dati

integer

Alias
Code-1
Identifier
UMLS CUI 2011AB
C0600091
SNOMEDCT_2012_01_31
118522005
Code-2
Hospitals
UMLS CUI 2011AB
C0019994
LOINC Version 232
MTHU002722
Patient identifier
Descrizione

Patienten-Nr.

Tipo di dati

integer

Alias
Code-1
Identifier
UMLS CUI 2011AB
C0600091
SNOMEDCT_2012_01_31
118522005
Code-2
Patients
UMLS CUI 2011AB
C0030705
SNOMEDCT_2012_01_31
116154003
Date of birth
Descrizione

Date of birth

Alias
Code-1
Patient date of birth
UMLS CUI 2011AB
C0421451
SNOMEDCT_2012_01_31
184099003
LOINC Version 232
MTHU009540
Month of birth
Descrizione

Geburtsmonat

Tipo di dati

integer

Alias
Code-1
month
UMLS CUI 2011AB
C0439231
SNOMEDCT_2012_01_31
258706009
HL7 V3 2006_05
MO
Day of birth
Descrizione

Geburtstag

Tipo di dati

integer

Alias
Code-1
day
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
LOINC Version 232
MTHU039849
HL7 V3 2006_05
D
Administrative Items
Descrizione

Administrative Items

Alias
Code-1
Administrative Items
UMLS CUI 2011AB
C2598108
LOINC Version 232
MTHU029788
Date of Evaluation
Descrizione

Beurteilungsdatum

Tipo di dati

date

Alias
Code-1
Evaluation
UMLS CUI 2011AB
C0220825
Code-2
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Date of diagnosis
Descrizione

Diagnosedatum

Tipo di dati

date

Alias
Code-1
Date of diagnosis
UMLS CUI 2011AB
C2316983
SNOMEDCT_2012_01_31
432213005
LOINC Version 232
MTHU038128
Sex
Descrizione

Geschlecht

Tipo di dati

integer

Alias
Code-1
Patient sex
UMLS CUI 2011AB
C0150831
SNOMEDCT_2012_01_31
184100006
Inclusion Criterion
Descrizione

Inclusion Criterion

Alias
Code-1
Inclusion Criteria
UMLS CUI 2011AB
C1512693
CML in chronic phase with cytogenetic proof of philadelphia-chromosome or variant translocation (BCR-ABL positive in multiplex-PCR)
Descrizione

CML in chronischer Phase mit zytogenetischem Nachweis des Philadelphia-Chromosoms oder vatiante Translokation (BCR-ABL-positiv in Multiplex-PCR)

Tipo di dati

boolean

Alias
Code-1
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
UMLS CUI 2011AB
C0023474
SNOMEDCT_2012_01_31
413847001
MedDRA 14.1
10054352
Date of Diagnosis not older than six months
Descrizione

Datum der Diagnose nicht älter als sechs Monate

Tipo di dati

boolean

Alias
Code-1
Date of diagnosis
UMLS CUI 2011AB
C2316983
SNOMEDCT_2012_01_31
432213005
LOINC Version 232
MTHU038128
Code-2
Age
UMLS CUI 2011AB
C0001779
SNOMEDCT_2012_01_31
397669002
LOINC Version 232
MTHU010047
Code-3
Negation
UMLS CUI 2011AB
C1518422
Code-4
Greater Than
UMLS CUI 2011AB
C0439093
SNOMEDCT_2012_01_31
276140008
HL7 V3 2006_05
GT
Code-5
Six
UMLS CUI 2011AB
C0205452
SNOMEDCT_2012_01_31
422218008
Code-6
month
UMLS CUI 2011AB
C0439231
SNOMEDCT_2012_01_31
258706009
CML so far untreated (Exception up to six months Hydroxyurea and/or up to six weeks Imatinib or Nilotinib)
Descrizione

CML bislang unbehandelt (Ausnahme bis zu sechs Monate Hydroxyurea und/oder bis zu sechs Wochen Imatinib oder Nilotinib)

Tipo di dati

boolean

Alias
Code-1
Myeloid Leukemia, Chronic
UMLS CUI 2011AB
C0023473
SNOMEDCT_2012_01_31
63364005
MedDRA 14.1
10009700
ICD-10-CM Version 2010
C92.1
ICD-9-CM Version 2011
205.1
Code-2
Without
UMLS CUI 2011AB
C0332288
SNOMEDCT_2012_01_31
45169001
Code-3
Therapeutic procedure
UMLS CUI 2011AB
C0087111
SNOMEDCT_2012_01_31
277132007
MedDRA 14.1
10053757
LOINC Version 232
MTHU021209
Code-4
exception - ResponseLevel
UMLS CUI 2011AB
C1554961
HL7 V3 2006_05
E
Code-5
Six
UMLS CUI 2011AB
C0205452
SNOMEDCT_2012_01_31
422218008
Code-6
month
UMLS CUI 2011AB
C0439231
SNOMEDCT_2012_01_31
258706009
Age at Inclusion minimum 18 years
Descrizione

Alter bei Studieneinschluss mindestens 18 Jahre

Tipo di dati

boolean

Alias
Code-1
patient age
UMLS CUI 2011AB
CL386174
Code-2
Enrollment
UMLS CUI 2011AB
C1516879
Code-3
Minimum
UMLS CUI 2011AB
C1524031
Code-4
Eight
UMLS CUI 2011AB
C0205454
SNOMEDCT_2012_01_31
421825006
Code-5
Ten
UMLS CUI 2011AB
C0205456
SNOMEDCT_2012_01_31
420258001
Code-6
year
UMLS CUI 2011AB
C0439234
SNOMEDCT_2012_01_31
258707000
Serum-values Potassium, Magnesium and Calcium greater or equal LLN respectively within normal range under supplementation
Descrizione

Serum-Werte Kalium, Magnesium und Kalzium größer oder gleich LLN (untere Normschranke) bzw. innerhalb des Normbereichs unter Supplementation

Tipo di dati

boolean

Alias
Code-1
Potassium [Mass or Molecules/volume] in Serum or Plasma
UMLS CUI 2011AB
C2363391
LOINC Version 232
42569-4
Code-2
Magnesium [Mass or Molecules/volume] in Serum or Plasma
UMLS CUI 2011AB
C2607855
LOINC Version 232
35249-2
Code-3
Calcium:MCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0800968
LOINC Version 232
35246-8
Code-4
Greater Than or Equal To
UMLS CUI 2011AB
C0439091
SNOMEDCT_2012_01_31
276138003
HL7 V3 2006_05
GE
Code-5
Lower Limit of Normal
UMLS CUI 2011AB
C1518030
Code-6
Normal Values
UMLS CUI 2011AB
C0086715
SNOMEDCT_2012_01_31
260395002
ASAT and ALAT less than or equal to 2.5 times UNL respectively less than or equal to 5 times ULN, if induced by leukemia
Descrizione

ASAT und ALAT kleiner oder gleich 2.5 x UNL (obere Normschranke) bzw. kleiner oder gleich 5 x ULN, falls durch die Leukämie induziert.

Tipo di dati

boolean

Alias
Code-1
Aspartate Transaminase
UMLS CUI 2011AB
C0004002
SNOMEDCT_2012_01_31
26091008
LOINC Version 232
MTHU004883
Code-2
And
UMLS CUI 2011AB
C1515981
Code-3
Alanine Transaminase
UMLS CUI 2011AB
C0001899
SNOMEDCT_2012_01_31
56935002
LOINC Version 232
MTHU006766
Code-4
Less Than or Equal to
UMLS CUI 2011AB
C0439090
SNOMEDCT_2012_01_31
276137008
HL7 V3 2006_05
LE
Code-5
Two
UMLS CUI 2011AB
C0205448
SNOMEDCT_2012_01_31
420797005
Code-6
Half
UMLS CUI 2011AB
C2825407
Alkaline Phosphatase less than or equal to 2.5 times UNL, if not induced by leukemia
Descrizione

Alkalische Phosphatase kleiner oder gleich 2.5 x UNL, falls nicht durch die Leukämie induziert.

Tipo di dati

boolean

Alias
Code-1
Alkaline phosphatase level - finding
UMLS CUI 2011AB
C0428332
SNOMEDCT_2012_01_31
365771003
Code-2
Less Than or Equal to
UMLS CUI 2011AB
C0439090
SNOMEDCT_2012_01_31
276137008
HL7 V3 2006_05
LE
Code-3
Two
UMLS CUI 2011AB
C0205448
SNOMEDCT_2012_01_31
420797005
Code-4
Half
UMLS CUI 2011AB
C2825407
Code-5
Times
UMLS CUI 2011AB
C1632851
SNOMEDCT_2012_01_31
417929005
Code-6
Upper Limit of Normal
UMLS CUI 2011AB
C1519815
Bilirubin total less than oder equal to 1.5 times ULN, if no Gilbert's syndrome known
Descrizione

Gesamt-Bilirubin kleiner oder gleich 1.5 x ULN, sofern kein bekannter Morbus Gilbert (Meulengracht)

Tipo di dati

boolean

Alias
Code-1
Total Bilirubin Measurement
UMLS CUI 2011AB
C0201913
SNOMEDCT_2012_01_31
359986008
MedDRA 14.1
10004696
Code-2
Less Than or Equal to
UMLS CUI 2011AB
C0439090
SNOMEDCT_2012_01_31
276137008
HL7 V3 2006_05
LE
Code-3
One
UMLS CUI 2011AB
C0205447
SNOMEDCT_2012_01_31
421379005
Code-4
Half
UMLS CUI 2011AB
C2825407
Code-5
Times
UMLS CUI 2011AB
C1632851
SNOMEDCT_2012_01_31
417929005
Code-6
Upper Limit of Normal
UMLS CUI 2011AB
C1519815
Serum-Lipase and Amylase less than or equal to 1.5 times ULN
Descrizione

Serum-Lipase und Amylase kleiner oder gleich 1.5 ULN

Tipo di dati

boolean

Alias
Code-1
Triacylglycerol lipase:CCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0365184
LOINC Version 232
3040-3
Code-2
Amylase:CCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0484652
LOINC Version 232
1798-8
Code-3
Less Than or Equal to
UMLS CUI 2011AB
C0439090
SNOMEDCT_2012_01_31
276137008
HL7 V3 2006_05
LE
Code-4
One
UMLS CUI 2011AB
C0205447
SNOMEDCT_2012_01_31
421379005
Code-5
Half
UMLS CUI 2011AB
C2825407
Code-6
Times
UMLS CUI 2011AB
C1632851
SNOMEDCT_2012_01_31
417929005
Serum-Creatinine less than or equal to 2 times ULN
Descrizione

Serum-Kreatinin kleiner oder gleich 2 x ULN

Tipo di dati

boolean

Alias
Code-1
Creatinine:Mass Concentration:Point in time:Serum/Plasma:Quantitative
UMLS CUI 2011AB
C2739805
LOINC Version 232
35203-9
Code-2
Less Than or Equal to
UMLS CUI 2011AB
C0439090
SNOMEDCT_2012_01_31
276137008
HL7 V3 2006_05
LE
Code-3
Two
UMLS CUI 2011AB
C0205448
SNOMEDCT_2012_01_31
420797005
Code-4
Times
UMLS CUI 2011AB
C1632851
SNOMEDCT_2012_01_31
417929005
Code-5
Upper Limit of Normal
UMLS CUI 2011AB
C1519815
ECOG Status within the range of 0 to 2
Descrizione

ECOG-Status im Bereich von 0 bis 2

Tipo di dati

boolean

Alias
Code-1
ECOG performance status - grade 0
UMLS CUI 2011AB
C1828078
SNOMEDCT_2012_01_31
425389002
Code-2
ECOG performance status - grade 1
UMLS CUI 2011AB
C1827388
SNOMEDCT_2012_01_31
422512005
Code-3
ECOG performance status - grade 2
UMLS CUI 2011AB
C1828242
SNOMEDCT_2012_01_31
422894000
Written informed consent obtained for each study intervention
Descrizione

Schriftliche Einwilligungserklärung des aufgeklärten Patienten vor jeglicher Studienintervention erhalten

Tipo di dati

boolean

Alias
Code-1
Informed consent obtained
UMLS CUI 2011AB
C0514044
LOINC Version 232
MTHU008888
Code-2
written - ParticipationMode
UMLS CUI 2011AB
C1576874
HL7 V3 2006_05
WRITTEN
Code-3
Intervention Studies
UMLS CUI 2011AB
C1096775
Code-4
Each
UMLS CUI 2011AB
C1457900
SNOMEDCT_2012_01_31
419473009
Signature
Descrizione

Signature

Alias
Code-1
Signature
UMLS CUI 2011AB
C1519316
Code-2
Bone Marrow Examination
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Hospital
Descrizione

Klinik

Tipo di dati

string

Alias
Code-1
Hospitals
UMLS CUI 2011AB
C0019994
LOINC Version 232
MTHU002722
Date
Descrizione

Datum

Tipo di dati

date

Alias
Code-1
Signature date
UMLS CUI 2011AB
C0807937
LOINC Version 232
MTHU008294
Signature
Descrizione

Unterschrift

Tipo di dati

string

Alias
Code-1
Investigator Signature
UMLS CUI 2011AB
C2346576
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Similar models

Einschlusskriterien

1 moduli
  1. StudyEvent: Chronic Myeloid Leukemia
    1. Einschlusskriterien
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Items
Administrative Items (Code-1)
C2598108 (UMLS CUI 2011AB)
MTHU029788 (LOINC Version 232)
Klinik-Nr.
Item
Hospital Identifier
integer
Identifier (Code-1)
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Hospitals (Code-2)
C0019994 (UMLS CUI 2011AB)
MTHU002722 (LOINC Version 232)
Patienten-Nr.
Item
Patient identifier
integer
Identifier (Code-1)
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Patients (Code-2)
C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
Item Group
Date of birth
Patient date of birth (Code-1)
C0421451 (UMLS CUI 2011AB)
184099003 (SNOMEDCT_2012_01_31)
MTHU009540 (LOINC Version 232)
Geburtsmonat
Item
Month of birth
integer
month (Code-1)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
MO (HL7 V3 2006_05)
Geburtstag
Item
Day of birth
integer
day (Code-1)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
MTHU039849 (LOINC Version 232)
D (HL7 V3 2006_05)
Item Group
Administrative Items
Administrative Items (Code-1)
C2598108 (UMLS CUI 2011AB)
MTHU029788 (LOINC Version 232)
Beurteilungsdatum
Item
Date of Evaluation
date
Evaluation (Code-1)
C0220825 (UMLS CUI 2011AB)
Date in time (Code-2)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Diagnosedatum
Item
Date of diagnosis
date
Date of diagnosis (Code-1)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
MTHU038128 (LOINC Version 232)
Item
Sex
integer
Patient sex (Code-1)
C0150831 (UMLS CUI 2011AB)
184100006 (SNOMEDCT_2012_01_31)
Geschlecht
Code List
Sex
CL Item
Male (männlich)
Male gender (Code-1)
C0086582 (UMLS CUI 2011AB)
10052007 (SNOMEDCT_2012_01_31)
CL Item
Female (weiblich)
C0086287 (UMLS CUI 2011AB)
1086007 (SNOMEDCT_2012_01_31)
Item Group
Inclusion Criterion
Inclusion Criteria (Code-1)
C1512693 (UMLS CUI 2011AB)
CML in chronischer Phase mit zytogenetischem Nachweis des Philadelphia-Chromosoms oder vatiante Translokation (BCR-ABL-positiv in Multiplex-PCR)
Item
CML in chronic phase with cytogenetic proof of philadelphia-chromosome or variant translocation (BCR-ABL positive in multiplex-PCR)
boolean
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive (Code-1)
C0023474 (UMLS CUI 2011AB)
413847001 (SNOMEDCT_2012_01_31)
10054352 (MedDRA 14.1)
Datum der Diagnose nicht älter als sechs Monate
Item
Date of Diagnosis not older than six months
boolean
Date of diagnosis (Code-1)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
MTHU038128 (LOINC Version 232)
Age (Code-2)
C0001779 (UMLS CUI 2011AB)
397669002 (SNOMEDCT_2012_01_31)
MTHU010047 (LOINC Version 232)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Greater Than (Code-4)
C0439093 (UMLS CUI 2011AB)
276140008 (SNOMEDCT_2012_01_31)
GT (HL7 V3 2006_05)
Six (Code-5)
C0205452 (UMLS CUI 2011AB)
422218008 (SNOMEDCT_2012_01_31)
month (Code-6)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
CML bislang unbehandelt (Ausnahme bis zu sechs Monate Hydroxyurea und/oder bis zu sechs Wochen Imatinib oder Nilotinib)
Item
CML so far untreated (Exception up to six months Hydroxyurea and/or up to six weeks Imatinib or Nilotinib)
boolean
Myeloid Leukemia, Chronic (Code-1)
C0023473 (UMLS CUI 2011AB)
63364005 (SNOMEDCT_2012_01_31)
10009700 (MedDRA 14.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
Without (Code-2)
C0332288 (UMLS CUI 2011AB)
45169001 (SNOMEDCT_2012_01_31)
Therapeutic procedure (Code-3)
C0087111 (UMLS CUI 2011AB)
277132007 (SNOMEDCT_2012_01_31)
10053757 (MedDRA 14.1)
MTHU021209 (LOINC Version 232)
exception - ResponseLevel (Code-4)
C1554961 (UMLS CUI 2011AB)
E (HL7 V3 2006_05)
Six (Code-5)
C0205452 (UMLS CUI 2011AB)
422218008 (SNOMEDCT_2012_01_31)
month (Code-6)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
Alter bei Studieneinschluss mindestens 18 Jahre
Item
Age at Inclusion minimum 18 years
boolean
patient age (Code-1)
CL386174 (UMLS CUI 2011AB)
Enrollment (Code-2)
C1516879 (UMLS CUI 2011AB)
Minimum (Code-3)
C1524031 (UMLS CUI 2011AB)
Eight (Code-4)
C0205454 (UMLS CUI 2011AB)
421825006 (SNOMEDCT_2012_01_31)
Ten (Code-5)
C0205456 (UMLS CUI 2011AB)
420258001 (SNOMEDCT_2012_01_31)
year (Code-6)
C0439234 (UMLS CUI 2011AB)
258707000 (SNOMEDCT_2012_01_31)
Serum-Werte Kalium, Magnesium und Kalzium größer oder gleich LLN (untere Normschranke) bzw. innerhalb des Normbereichs unter Supplementation
Item
Serum-values Potassium, Magnesium and Calcium greater or equal LLN respectively within normal range under supplementation
boolean
Potassium [Mass or Molecules/volume] in Serum or Plasma (Code-1)
C2363391 (UMLS CUI 2011AB)
42569-4 (LOINC Version 232)
Magnesium [Mass or Molecules/volume] in Serum or Plasma (Code-2)
C2607855 (UMLS CUI 2011AB)
35249-2 (LOINC Version 232)
Calcium:MCnc:Pt:Ser/Plas:Qn (Code-3)
C0800968 (UMLS CUI 2011AB)
35246-8 (LOINC Version 232)
Greater Than or Equal To (Code-4)
C0439091 (UMLS CUI 2011AB)
276138003 (SNOMEDCT_2012_01_31)
GE (HL7 V3 2006_05)
Lower Limit of Normal (Code-5)
C1518030 (UMLS CUI 2011AB)
Normal Values (Code-6)
C0086715 (UMLS CUI 2011AB)
260395002 (SNOMEDCT_2012_01_31)
ASAT und ALAT kleiner oder gleich 2.5 x UNL (obere Normschranke) bzw. kleiner oder gleich 5 x ULN, falls durch die Leukämie induziert.
Item
ASAT and ALAT less than or equal to 2.5 times UNL respectively less than or equal to 5 times ULN, if induced by leukemia
boolean
Aspartate Transaminase (Code-1)
C0004002 (UMLS CUI 2011AB)
26091008 (SNOMEDCT_2012_01_31)
MTHU004883 (LOINC Version 232)
And (Code-2)
C1515981 (UMLS CUI 2011AB)
Alanine Transaminase (Code-3)
C0001899 (UMLS CUI 2011AB)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)
Less Than or Equal to (Code-4)
C0439090 (UMLS CUI 2011AB)
276137008 (SNOMEDCT_2012_01_31)
LE (HL7 V3 2006_05)
Two (Code-5)
C0205448 (UMLS CUI 2011AB)
420797005 (SNOMEDCT_2012_01_31)
Half (Code-6)
C2825407 (UMLS CUI 2011AB)
Alkalische Phosphatase kleiner oder gleich 2.5 x UNL, falls nicht durch die Leukämie induziert.
Item
Alkaline Phosphatase less than or equal to 2.5 times UNL, if not induced by leukemia
boolean
Alkaline phosphatase level - finding (Code-1)
C0428332 (UMLS CUI 2011AB)
365771003 (SNOMEDCT_2012_01_31)
Less Than or Equal to (Code-2)
C0439090 (UMLS CUI 2011AB)
276137008 (SNOMEDCT_2012_01_31)
LE (HL7 V3 2006_05)
Two (Code-3)
C0205448 (UMLS CUI 2011AB)
420797005 (SNOMEDCT_2012_01_31)
Half (Code-4)
C2825407 (UMLS CUI 2011AB)
Times (Code-5)
C1632851 (UMLS CUI 2011AB)
417929005 (SNOMEDCT_2012_01_31)
Upper Limit of Normal (Code-6)
C1519815 (UMLS CUI 2011AB)
Gesamt-Bilirubin kleiner oder gleich 1.5 x ULN, sofern kein bekannter Morbus Gilbert (Meulengracht)
Item
Bilirubin total less than oder equal to 1.5 times ULN, if no Gilbert's syndrome known
boolean
Total Bilirubin Measurement (Code-1)
C0201913 (UMLS CUI 2011AB)
359986008 (SNOMEDCT_2012_01_31)
10004696 (MedDRA 14.1)
Less Than or Equal to (Code-2)
C0439090 (UMLS CUI 2011AB)
276137008 (SNOMEDCT_2012_01_31)
LE (HL7 V3 2006_05)
One (Code-3)
C0205447 (UMLS CUI 2011AB)
421379005 (SNOMEDCT_2012_01_31)
Half (Code-4)
C2825407 (UMLS CUI 2011AB)
Times (Code-5)
C1632851 (UMLS CUI 2011AB)
417929005 (SNOMEDCT_2012_01_31)
Upper Limit of Normal (Code-6)
C1519815 (UMLS CUI 2011AB)
Serum-Lipase und Amylase kleiner oder gleich 1.5 ULN
Item
Serum-Lipase and Amylase less than or equal to 1.5 times ULN
boolean
Triacylglycerol lipase:CCnc:Pt:Ser/Plas:Qn (Code-1)
C0365184 (UMLS CUI 2011AB)
3040-3 (LOINC Version 232)
Amylase:CCnc:Pt:Ser/Plas:Qn (Code-2)
C0484652 (UMLS CUI 2011AB)
1798-8 (LOINC Version 232)
Less Than or Equal to (Code-3)
C0439090 (UMLS CUI 2011AB)
276137008 (SNOMEDCT_2012_01_31)
LE (HL7 V3 2006_05)
One (Code-4)
C0205447 (UMLS CUI 2011AB)
421379005 (SNOMEDCT_2012_01_31)
Half (Code-5)
C2825407 (UMLS CUI 2011AB)
Times (Code-6)
C1632851 (UMLS CUI 2011AB)
417929005 (SNOMEDCT_2012_01_31)
Serum-Kreatinin kleiner oder gleich 2 x ULN
Item
Serum-Creatinine less than or equal to 2 times ULN
boolean
Creatinine:Mass Concentration:Point in time:Serum/Plasma:Quantitative (Code-1)
C2739805 (UMLS CUI 2011AB)
35203-9 (LOINC Version 232)
Less Than or Equal to (Code-2)
C0439090 (UMLS CUI 2011AB)
276137008 (SNOMEDCT_2012_01_31)
LE (HL7 V3 2006_05)
Two (Code-3)
C0205448 (UMLS CUI 2011AB)
420797005 (SNOMEDCT_2012_01_31)
Times (Code-4)
C1632851 (UMLS CUI 2011AB)
417929005 (SNOMEDCT_2012_01_31)
Upper Limit of Normal (Code-5)
C1519815 (UMLS CUI 2011AB)
ECOG-Status im Bereich von 0 bis 2
Item
ECOG Status within the range of 0 to 2
boolean
ECOG performance status - grade 0 (Code-1)
C1828078 (UMLS CUI 2011AB)
425389002 (SNOMEDCT_2012_01_31)
ECOG performance status - grade 1 (Code-2)
C1827388 (UMLS CUI 2011AB)
422512005 (SNOMEDCT_2012_01_31)
ECOG performance status - grade 2 (Code-3)
C1828242 (UMLS CUI 2011AB)
422894000 (SNOMEDCT_2012_01_31)
Schriftliche Einwilligungserklärung des aufgeklärten Patienten vor jeglicher Studienintervention erhalten
Item
Written informed consent obtained for each study intervention
boolean
Informed consent obtained (Code-1)
C0514044 (UMLS CUI 2011AB)
MTHU008888 (LOINC Version 232)
written - ParticipationMode (Code-2)
C1576874 (UMLS CUI 2011AB)
WRITTEN (HL7 V3 2006_05)
Intervention Studies (Code-3)
C1096775 (UMLS CUI 2011AB)
Each (Code-4)
C1457900 (UMLS CUI 2011AB)
419473009 (SNOMEDCT_2012_01_31)
Item Group
Signature
Signature (Code-1)
C1519316 (UMLS CUI 2011AB)
Bone Marrow Examination (Code-2)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Klinik
Item
Hospital
string
Hospitals (Code-1)
C0019994 (UMLS CUI 2011AB)
MTHU002722 (LOINC Version 232)
Datum
Item
Date
date
Signature date (Code-1)
C0807937 (UMLS CUI 2011AB)
MTHU008294 (LOINC Version 232)
Unterschrift
Item
Signature
string
Investigator Signature (Code-1)
C2346576 (UMLS CUI 2011AB)
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