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Informações:
Falhas:
ID
4281
Descrição
ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00952588
Link
http://clinicaltrials.gov/ct2/show/record/NCT00952588
Palavras-chave
Versões (4)
- 14/11/2011 14/11/2011 -
- 06/12/2013 06/12/2013 - Martin Dugas
- 11/04/2014 11/04/2014 - Julian Varghese
- 16/12/2014 16/12/2014 - Martin Dugas
Transferido a
6 de dezembro de 2013
DOI
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Licença
Creative Commons BY-NC 3.0 Legacy
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Eligibility Criteria NCT00952588
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
consent
Item
Provision of written informed consent
boolean
Age
Item
Newly diagnosed male or female patients aged 60 and over
boolean
Diagnosis
Item
De Novo or Secondary AML
boolean
Other
Item
Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following: Age ?75 years; Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia
boolean
other trial
Item
Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product
boolean
Contraindication LDAC
Item
Administration of LDAC is clinically contraindicated
boolean
M3
Item
Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
boolean
CML blast crisis
Item
Patients with blast crisis of chronic myeloid leukaemia
boolean
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
439401001 (SNOMED CT 2010_0731)
AML
Item
Acute myeloic leukemia
string
C0023467 (UMLS CUI)
91861009 (SNOMED CT 2010_0731)
10000880 (MedDRA 13.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
91861009 (SNOMED CT 2010_0731)
10000880 (MedDRA 13.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
WHO performance status finding
Item
WHO performance status finding
string
C1298651 (UMLS CUI)
373802001 (SNOMED CT 2010_0731)
373802001 (SNOMED CT 2010_0731)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Contraindication to medical treatment
Item
Contraindication to medical treatment
string
C0852648 (UMLS CUI)
10010833 (MedDRA 13.1)
10010833 (MedDRA 13.1)
APL
Item
Acute Promyelocytic Leukemia
string
C0023487 (UMLS CUI)
110004001 (SNOMED CT 2010_0731)
10001019 (MedDRA 13.1)
C92.4 (ICD-10-CM Version 2010)
110004001 (SNOMED CT 2010_0731)
10001019 (MedDRA 13.1)
C92.4 (ICD-10-CM Version 2010)
CML
Item
Chronic myeloid leukemia
string
C0023473 (UMLS CUI)
63364005 (SNOMED CT 2010_0731)
10009700 (MedDRA 13.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
63364005 (SNOMED CT 2010_0731)
10009700 (MedDRA 13.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
Blast crisis
Item
Blast phase
string
C0005699 (UMLS CUI)
278180008 (SNOMED CT 2010_0731)
10053747 (MedDRA 13.1)
278180008 (SNOMED CT 2010_0731)
10053747 (MedDRA 13.1)