ID
44592
Descrição
ODM derived from http://clinicaltrials.gov/show/NCT01018069
Link
http://clinicaltrials.gov/show/NCT01018069
Palavras-chave
Versões (3)
- 07/12/2013 07/12/2013 - Martin Dugas
- 17/04/2014 17/04/2014 - Julian Varghese
- 27/09/2021 27/09/2021 -
Transferido a
27 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility NCT01018069 Leukemia
Eligibility
- StudyEvent: Eligibility
Descrição
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descrição
Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0549178
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0205488
- SNOMED CT 2011_0131
- 57407000
- UMLS CUI 2011AA
- C2826262
- UMLS CUI 2011AA
- C0205449
- SNOMED CT 2011_0131
- 421291004
- UMLS CUI 2011AA
- C0205450
- SNOMED CT 2011_0131
- 9362000
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
- UMLS CUI 2011AA
- C0205263
- SNOMED CT 2011_0131
- 16404004
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
Descrição
Patients with a prior history of peripheral neuropathy of grade >= 2.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0031117
- MedDRA 14.1
- 10029331
- ICD-10-CM Version 2010
- G64
- ICD-9-CM Version 2011
- 350-359.99
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Descrição
Clinical evidence of active CNS leukemic involvement.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1332884
- SNOMED CT 2011_0131
- 10067299
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
Descrição
Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0009450
Descrição
Current evidence of invasive fungal infection (blood or tissue culture).
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205281
- SNOMED CT 2011_0131
- 10179008
- UMLS CUI 2011AA
- C0026946
- SNOMED CT 2011_0131
- 3218000
- MedDRA 14.1
- 10017533
- ICD-10-CM Version 2010
- B35-B49
- ICD-9-CM Version 2011
- 110-118.99
- UMLS CUI 2011AA
- C0200949
- SNOMED CT 2011_0131
- 30088009
- MedDRA 14.1
- 10005485
- ICD-9-CM Version 2011
- 90.52
- UMLS CUI 2011AA
- C0040284
- SNOMED CT 2011_0131
- 77601007
Descrição
Current evidence of an active second malignancy except for non-melanoma skin cancer.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0085183
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0699893
- MedDRA 14.1
- 10040810
Descrição
Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1522577
Descrição
Neurological or psychiatric disorders that would interfere with consent or study follow-up.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0021430
Descrição
Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1744706
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
- UMLS CUI 2011AA
- CL414967
- UMLS CUI 2011AA
- C0079925
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
- UMLS CUI 2011AA
- C0020789
- SNOMED CT 2011_0131
- 372539000
Descrição
History of alcohol or other substance abuse within the last year.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0085762
Descrição
Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0205448
- SNOMED CT 2011_0131
- 19338005
- 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
- C1516879
Descrição
Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
Tipo de dados
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
- C2828358
- UMLS CUI 2011AA
- C0240802
- SNOMED CT 2011_0131
- 250423000
- MedDRA 14.1
- 10036575
- UMLS CUI 2011AA
- C1409616
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
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439401001 (SNOMED CT 2011_0131)
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10000880 (MedDRA 14.1)
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50820005 (SNOMED CT 2011_0131)
10066274 (MedDRA 14.1)
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10019481 (MedDRA 14.1)
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MTHU002432 (LOINC Version 232)
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30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
424122007 (SNOMED CT 2011_0131)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0002453 (UMLS CUI 2011AA)
14302001 (SNOMED CT 2011_0131)
10001928 (MedDRA 14.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0205460 (UMLS CUI 2011AA)
12893009 (SNOMED CT 2011_0131)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
88323005 (SNOMED CT 2011_0131)
C0678852 (UMLS CUI 2011AA)
C1817756 (UMLS CUI 2011AA)
106183005 (SNOMED CT 2011_0131)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
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MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
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MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
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C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
CL357089 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C2826262 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
392521001 (SNOMED CT 2011_0131)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
55561003 (SNOMED CT 2011_0131)
C1332884 (UMLS CUI 2011AA)
10067299 (SNOMED CT 2011_0131)
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248448006 (SNOMED CT 2011_0131)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
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30088009 (SNOMED CT 2011_0131)
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77601007 (SNOMED CT 2011_0131)
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C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
CL414967 (UMLS CUI 2011AA)
C0079925 (UMLS CUI 2011AA)
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89265009 (SNOMED CT 2011_0131)
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372539000 (SNOMED CT 2011_0131)
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C0013230 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
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288556008 (SNOMED CT 2011_0131)
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