ID
42904
Description
http://clinicaltrials.gov/ct2/show/NCT01657604
Link
http://clinicaltrials.gov/ct2/show/NCT01657604
Keywords
Versions (2)
- 18/01/2014 18/01/2014 -
- 17/09/2021 17/09/2021 -
Uploaded on
17 de setembro de 2021
DOI
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License
Creative Commons BY 4.0
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Einschlusskriterien DRKS00005243 NCT01657604 Chronic Myeloid Leukemia
Einschlusskriterien
- StudyEvent: Chronic Myeloid Leukemia
Description
Geburtsdatum
Alias
- Code-1
- Patient date of birth
- UMLS CUI 2011AB
- C0421451
- SNOMEDCT_2012_01_31
- 184099003
- LOINC Version 232
- MTHU009540
Description
Geburtsmonat
Data type
integer
Alias
- Code-1
- month
- UMLS CUI 2011AB
- C0439231
- SNOMEDCT_2012_01_31
- 258706009
- HL7 V3 2006_05
- MO
Description
Geburtstag
Data type
integer
Alias
- Code-1
- day
- UMLS CUI 2011AB
- C0439228
- SNOMEDCT_2012_01_31
- 258703001
- LOINC Version 232
- MTHU039849
- HL7 V3 2006_05
- D
Description
Adiminstrative Daten II
Alias
- Code-1
- Administrative Items
- UMLS CUI 2011AB
- C2598108
- LOINC Version 232
- MTHU029788
Description
Beurteilungsdatum
Data type
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
Description
Diagnosedatum
Data type
date
Alias
- Code-1
- Date of diagnosis
- UMLS CUI 2011AB
- C2316983
- SNOMEDCT_2012_01_31
- 432213005
- LOINC Version 232
- MTHU038128
Description
Geschlecht
Data type
integer
Alias
- Code-1
- Patient sex
- UMLS CUI 2011AB
- C0150831
- SNOMEDCT_2012_01_31
- 184100006
Description
Einschlusskriterium
Alias
- Code-1
- Inclusion Criteria
- UMLS CUI 2011AB
- C1512693
Description
CML in chronischer Phase mit zytogenetischem Nachweis des Philadelphia-Chromosoms oder vatiante Translokation (BCR-ABL-positiv in Multiplex-PCR)
Data type
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
Description
Datum der Diagnose nicht älter als sechs Monate
Data type
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
Description
CML bislang unbehandelt (Ausnahme bis zu sechs Monate Hydroxyurea und/oder bis zu sechs Wochen Imatinib oder Nilotinib)
Data type
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
Description
Alter bei Studieneinschluss mindestens 18 Jahre
Data type
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
Description
Serum-Werte Kalium, Magnesium und Kalzium größer oder gleich LLN (untere Normschranke) bzw. innerhalb des Normbereichs unter Supplementation
Data type
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
Description
ASAT und ALAT kleiner oder gleich 2.5 x UNL (obere Normschranke) bzw. kleiner oder gleich 5 x ULN, falls durch die Leukämie induziert.
Data type
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
Description
Alkalische Phosphatase kleiner oder gleich 2.5 x UNL, falls nicht durch die Leukämie induziert.
Data type
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
Description
Gesamt-Bilirubin kleiner oder gleich 1.5 x ULN, sofern kein bekannter Morbus Gilbert (Meulengracht)
Data type
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
Description
Serum-Lipase und Amylase kleiner oder gleich 1.5 ULN
Data type
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
Description
Serum-Kreatinin kleiner oder gleich 2 x ULN
Data type
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
Description
ECOG-Status im Bereich von 0 bis 2
Data type
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
Description
Schriftliche Einwilligungserklärung des aufgeklärten Patienten vor jeglicher Studienintervention erhalten
Data type
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
Description
Unterschrift
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
Description
Klinik
Data type
string
Alias
- Code-1
- Hospitals
- UMLS CUI 2011AB
- C0019994
- LOINC Version 232
- MTHU002722
Description
Datum
Data type
date
Alias
- Code-1
- Signature date
- UMLS CUI 2011AB
- C0807937
- LOINC Version 232
- MTHU008294
Description
Unterschrift
Data type
string
Alias
- Code-1
- Investigator Signature
- UMLS CUI 2011AB
- C2346576
Similar models
Einschlusskriterien
- StudyEvent: Chronic Myeloid Leukemia
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Hospitals (Code-2)
C0019994 (UMLS CUI 2011AB)
MTHU002722 (LOINC Version 232)
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Patients (Code-2)
C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
C0421451 (UMLS CUI 2011AB)
184099003 (SNOMEDCT_2012_01_31)
MTHU009540 (LOINC Version 232)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
MO (HL7 V3 2006_05)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
MTHU039849 (LOINC Version 232)
D (HL7 V3 2006_05)
C0220825 (UMLS CUI 2011AB)
Date in time (Code-2)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
MTHU038128 (LOINC Version 232)
C0150831 (UMLS CUI 2011AB)
184100006 (SNOMEDCT_2012_01_31)
C0086582 (UMLS CUI 2011AB)
10052007 (SNOMEDCT_2012_01_31)
1086007 (SNOMEDCT_2012_01_31)
C1512693 (UMLS CUI 2011AB)
C0023474 (UMLS CUI 2011AB)
413847001 (SNOMEDCT_2012_01_31)
10054352 (MedDRA 14.1)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
C1519316 (UMLS CUI 2011AB)
Bone Marrow Examination (Code-2)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
C2346576 (UMLS CUI 2011AB)