ID

4281

Descripción

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00952588

Link

http://clinicaltrials.gov/ct2/show/record/NCT00952588

Palabras clave

  1. 14/11/11 14/11/11 -
  2. 6/12/13 6/12/13 - Martin Dugas
  3. 11/4/14 11/4/14 - Julian Varghese
  4. 16/12/14 16/12/14 - Martin Dugas
Subido en

6 de diciembre de 2013

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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Eligibility Criteria NCT00952588

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion
Descripción

Inclusion

Provision of written informed consent
Descripción

consent

Tipo de datos

boolean

Newly diagnosed male or female patients aged 60 and over
Descripción

Age

Tipo de datos

boolean

De Novo or Secondary AML
Descripción

Diagnosis

Tipo de datos

boolean

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
Descripción

Other

Tipo de datos

boolean

Exclusion
Descripción

Exclusion

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
Descripción

other trial

Tipo de datos

boolean

Administration of LDAC is clinically contraindicated
Descripción

Contraindication LDAC

Tipo de datos

boolean

Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
Descripción

M3

Tipo de datos

boolean

Patients with blast crisis of chronic myeloid leukaemia
Descripción

CML blast crisis

Tipo de datos

boolean

Medical concepts
Descripción

Medical concepts

Informed Consent
Descripción

Informed Consent

Tipo de datos

string

Alias
UMLS CUI
C0021430
Age
Descripción

Age

Tipo de datos

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Descripción

Diagnosis

Tipo de datos

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Acute myeloic leukemia
Descripción

AML

Tipo de datos

string

Alias
UMLS CUI
C0023467
SNOMED CT 2010_0731
91861009
MedDRA 13.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
WHO performance status finding
Descripción

WHO performance status finding

Tipo de datos

string

Alias
UMLS CUI
C1298651
SNOMED CT 2010_0731
373802001
Enrollment
Descripción

Enrollment

Tipo de datos

string

Alias
UMLS CUI
C1516879
Contraindication to medical treatment
Descripción

Contraindication to medical treatment

Tipo de datos

string

Alias
UMLS CUI
C0852648
MedDRA 13.1
10010833
Acute Promyelocytic Leukemia
Descripción

APL

Tipo de datos

string

Alias
UMLS CUI
C0023487
SNOMED CT 2010_0731
110004001
MedDRA 13.1
10001019
ICD-10-CM Version 2010
C92.4
Chronic myeloid leukemia
Descripción

CML

Tipo de datos

string

Alias
UMLS CUI
C0023473
SNOMED CT 2010_0731
63364005
MedDRA 13.1
10009700
ICD-10-CM Version 2010
C92.1
ICD-9-CM Version 2011
205.1
Blast phase
Descripción

Blast crisis

Tipo de datos

string

Alias
UMLS CUI
C0005699
SNOMED CT 2010_0731
278180008
MedDRA 13.1
10053747

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion
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
Item Group
Exclusion
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
Item Group
Medical concepts
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
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)
WHO performance status finding
Item
WHO performance status finding
string
C1298651 (UMLS CUI)
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)
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)
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)
Blast crisis
Item
Blast phase
string
C0005699 (UMLS CUI)
278180008 (SNOMED CT 2010_0731)
10053747 (MedDRA 13.1)

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