ID
44592
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT01018069
Link
http://clinicaltrials.gov/show/NCT01018069
Trefwoorden
Versies (3)
- 07-12-13 07-12-13 - Martin Dugas
- 17-04-14 17-04-14 - Julian Varghese
- 27-09-21 27-09-21 -
Geüploaded op
27 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility NCT01018069 Leukemia
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
Datatype
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
Beschrijving
Patients with a prior history of peripheral neuropathy of grade >= 2.
Datatype
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
Beschrijving
Clinical evidence of active CNS leukemic involvement.
Datatype
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
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0009450
Beschrijving
Current evidence of invasive fungal infection (blood or tissue culture).
Datatype
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
Beschrijving
Current evidence of an active second malignancy except for non-melanoma skin cancer.
Datatype
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
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1522577
Beschrijving
Neurological or psychiatric disorders that would interfere with consent or study follow-up.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0021430
Beschrijving
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.
Datatype
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
Beschrijving
History of alcohol or other substance abuse within the last year.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0085762
Beschrijving
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.
Datatype
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
Beschrijving
Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
Datatype
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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