ID
43394
Description
ODM derived from http://clinicaltrials.gov/show/NCT00632749
Link
http://clinicaltrials.gov/show/NCT00632749
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/15/14 4/15/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility DRKS00003742 NCT00632749 Leukemia, Myeloid, Acute
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0023487
- SNOMED CT 2011_0131
- 110004001
- MedDRA 14.1
- 10001019
- ICD-10-CM Version 2010
- C92.4
- UMLS CUI 2011AA
- C0023467
- SNOMED CT 2011_0131
- 91861009
- MedDRA 14.1
- 10000880
- ICD-10-CM Version 2010
- C92.0
- ICD-9-CM Version 2011
- 205.0
- UMLS CUI 2011AA
- C0449560
- SNOMED CT 2011_0131
- 260837004
- UMLS CUI 2011AA
- C0680240
- UMLS CUI 2011AA
- CL421536
Description
Relapsed or treatment refractory AML.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0278780
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205269
- SNOMED CT 2011_0131
- 20646008
- UMLS CUI 2011AA
- C0023467
- SNOMED CT 2011_0131
- 91861009
- MedDRA 14.1
- 10000880
- ICD-10-CM Version 2010
- C92.0
- ICD-9-CM Version 2011
- 205.0
Description
Hypersensitivity to one of the trial drugs or the excipients.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
Description
Other malignancy requiring treatment.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0039798
Description
Known central nervous system involvement.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0449389
- SNOMED CT 2011_0131
- 260766009
Description
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C1632851
- SNOMED CT 2011_0131
- 417929005
- UMLS CUI 2011AA
- C1519815
Description
INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0525032
- SNOMED CT 2011_0131
- 165581004
- MedDRA 14.1
- 10022400
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1611640
- SNOMED CT 2011_0131
- 5487002
- HL7 V3 2006_05
- THER
- UMLS CUI 2011AA
- C1096489
- MedDRA 14.1
- 10053755
- UMLS CUI 2011AA
- C0031444
- SNOMED CT 2011_0131
- 59488002
- LOINC Version 232
- MTHU016364
- UMLS CUI 2011AA
- C0043031
- SNOMED CT 2011_0131
- 48603004
- LOINC Version 232
- MTHU003212
Description
Bilirubin > 1.5 mg/dl.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
Description
Serum creatinine > 2.0 mg/dl.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Description
LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0428772
- SNOMED CT 2011_0131
- 250908004
- MedDRA 14.1
- 10069170
- UMLS CUI 2011AA
- C0013516
- SNOMED CT 2011_0131
- 40701008
- MedDRA 14.1
- 10014116
- ICD-9-CM Version 2011
- 88.72
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C0018802
- SNOMED CT 2011_0131
- 42343007
- MedDRA 14.1
- 10007559
- LOINC Version 232
- MTHU020787
- ICD-10-CM Version 2010
- I50.9
- ICD-9-CM Version 2011
- 428.0
- UMLS CUI 2011AA
- C1319795
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
- UMLS CUI 2011AA
- C1319796
- SNOMED CT 2011_0131
- 422293003
- MedDRA 14.1
- 10064082
Description
Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0243087
- UMLS CUI 2011AA
- C0277557
- SNOMED CT 2011_0131
- 88472004
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C0220825
- UMLS CUI 2011AA
- C1280519
- SNOMED CT 2011_0131
- 255403003
- UMLS CUI 2011AA
- C0036043
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
- UMLS CUI 2011AA
- C0003811
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
Description
Psychiatric illness or social situation that would limit compliance with trial requirements.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C0851364
- MedDRA 14.1
- 10041244
- UMLS CUI 2011AA
- C0439801
- SNOMED CT 2011_0131
- 255469002
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 405078008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514873
Description
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1707479
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C0220825
- UMLS CUI 2011AA
- C1280519
- SNOMED CT 2011_0131
- 255403003
- UMLS CUI 2011AA
- C0036043
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0021083
- SNOMED CT 2011_0131
- 146638005
Description
Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0680240
- UMLS CUI 2011AA
- C1709515
Description
Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0241028
- SNOMED CT 2011_0131
- 228453005
- MedDRA 14.1
- 10066098
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0600109
- SNOMED CT 2011_0131
- 225466006
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0700589
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- CL424941
- UMLS CUI 2011AA
- C0021900
- SNOMED CT 2011_0131
- 268460000
- MedDRA 14.1
- 10022745
- UMLS CUI 2011AA
- C0677582
- UMLS CUI 2011AA
- C0037862
- SNOMED CT 2011_0131
- 425484006
Description
Pregnant or nursing female patients.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Description
Patient unable to comply with the protocol.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 371151008
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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M (HL7 V3 2006_05)
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36692007 (SNOMED CT 2011_0131)
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260766009 (SNOMED CT 2011_0131)
26091008 (SNOMED CT 2011_0131)
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56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1632851 (UMLS CUI 2011AA)
417929005 (SNOMED CT 2011_0131)
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165581004 (SNOMED CT 2011_0131)
10022400 (MedDRA 14.1)
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C1518422 (UMLS CUI 2011AA)
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10064081 (MedDRA 14.1)
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10064082 (MedDRA 14.1)
C0277557 (UMLS CUI 2011AA)
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260379002 (SNOMED CT 2011_0131)
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228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL424941 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0677582 (UMLS CUI 2011AA)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
371151008 (SNOMED CT 2011_0131)