ID
4449
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00701766
Link
http://clinicaltrials.gov/show/NCT00701766
Trefwoorden
Versies (4)
- 09-12-13 09-12-13 - Martin Dugas
- 16-04-14 16-04-14 - Julian Varghese
- 16-04-14 16-04-14 - Julian Varghese
- 20-09-21 20-09-21 -
Geüploaded op
9 december 2013
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00701766 Leukemia, Myeloid, Acute
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3)
Datatype
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
- C0457329
- SNOMED CT 2011_0131
- 278165002
Beschrijving
Hypersensitivity to the trial drug or the excipients
Datatype
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
Beschrijving
Secondary malignancy requiring therapy
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2939419
- SNOMED CT 2011_0131
- 128462008
- MedDRA 14.1
- 10061289
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0039798
Beschrijving
Known central nervous system involvement
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0449389
- SNOMED CT 2011_0131
- 260766009
Beschrijving
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal, or AST or ALT > 5 times the upper limit of normal in case of known liver involvement
Datatype
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
- CL384738
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- CL414906
- UMLS CUI 2011AA
- CL384738
- UMLS CUI 2011AA
- C0205451
- SNOMED CT 2011_0131
- 34001005
- UMLS CUI 2011AA
- C1632851
- SNOMED CT 2011_0131
- 417929005
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C0750557
- UMLS CUI 2011AA
- C0023884
- SNOMED CT 2011_0131
- 10200004
- LOINC Version 232
- MTHU002039
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
Beschrijving
Bilirubin > 1.5 mg/dl (> 26 mcmol/l, SI unit equivalent)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011221
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
- UMLS CUI 2011AA
- C1705302
- UMLS CUI 2011AA
- CL415123
Beschrijving
Serum creatinine > 2.0 mg/dl
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL415222
- 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
- C0021311
- 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
Beschrijving
Psychiatric illness or social situation that would limit compliance with trial requirements
Datatype
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
- C0449295
- SNOMED CT 2011_0131
- 246175000
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 405078008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514873
Beschrijving
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Datatype
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
Beschrijving
Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0020402
- SNOMED CT 2011_0131
- 56602009
- UMLS CUI 2011AA
- C0021083
- SNOMED CT 2011_0131
- 146638005
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- C1444637
- SNOMED CT 2011_0131
- 410513005
- UMLS CUI 2011AA
- C0205450
- SNOMED CT 2011_0131
- 9362000
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013227
Beschrijving
Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0546816
- SNOMED CT 2011_0131
- 130965009
- UMLS CUI 2011AA
- C0040539
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0521124
- SNOMED CT 2011_0131
- 65897001
- UMLS CUI 2011AA
- C0023418
- SNOMED CT 2011_0131
- 93143009
- MedDRA 14.1
- 10024288
- ICD-10-CM Version 2010
- C95.9
- ICD-9-CM Version 2011
- 208.9
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C2347946
Beschrijving
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.)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C0241028
- SNOMED CT 2011_0131
- 228453005
- MedDRA 14.1
- 10066098
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C1879533
- 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
Beschrijving
Patient unable to comply with the protocol
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C0525058
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10022745 (MedDRA 14.1)
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425484006 (SNOMED CT 2011_0131)
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