ID

14031

Descripción

Azacytidine (Vidaza®) Versus Fludarabine and Cytarabine (Fluga Scheme) in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02319135

Link

https://clinicaltrials.gov/show/NCT02319135

Palabras clave

  1. 22/3/16 22/3/16 -
Subido en

22 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT02319135

Eligibility Acute Myeloid Leukemia NCT02319135

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
Having voluntarily given informed consent before performing any test that is not part of
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Routine care of patients.
Descripción

Routine care

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1547137
Age greater than or equal to 65.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Morphological diagnosis of non-promyelocytic aml according to the who criteria.
Descripción

AML

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
Ecog performance status <4.
Descripción

ECOG

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Ability and willingness to comply with the schedule of study visits.
Descripción

Compliance with study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
Genetic diagnosis of acute promyelocytic leukemia.
Descripción

Acute Promyelocytic Leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023487
Patients with aml secondary to myelodysplastic syndrome (mds) or chronic myeloproloferative syndrome who have been previously treated with antileukemic agents
Descripción

aml secondary to myelodysplastic syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280449
hypomethylating or standard chemotherapy.
Descripción

treatment with hydroxyurea prior to randomization is allowed.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3665472
serum creatinine ≥ 250 mmol / l (≥ 2.5 mg/dl) (unless attributed to aml).
Descripción

serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600061
bilirubin, alkaline phosphatase or alt > 5 times the value of the upper limit of normal (unless attributed to aml) .
Descripción

bilirubin, alkaline phosphatase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005437
UMLS CUI [2]
C0002059
presence of an active and/or non controlled pathology different to aml which is severe and life-threatening, that in the investigator's opinion, prevents the subject participation in the study.
Descripción

Life-threatening disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517874
other active concomitant malignancy or whose remission is less than one year from the screening day (except carcinoma in situ).
Descripción

concomitant disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0243087
presence of any psychiatric illness or medical condition that, in the investigator's opinion, prevents the subject participation in the study.
Descripción

Mental disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
life expectancy less than x months.
Descripción

life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
inability of the patient or his legal representative to understand and voluntarily sign the informed consent form.
Descripción

No informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Acute Myeloid Leukemia NCT02319135

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
Having voluntarily given informed consent before performing any test that is not part of
boolean
C0021430 (UMLS CUI [1])
Routine care
Item
Routine care of patients.
boolean
C1547137 (UMLS CUI [1])
Age
Item
Age greater than or equal to 65.
boolean
C0001779 (UMLS CUI [1])
AML
Item
Morphological diagnosis of non-promyelocytic aml according to the who criteria.
boolean
C0023467 (UMLS CUI [1])
ECOG
Item
Ecog performance status <4.
boolean
C1520224 (UMLS CUI [1])
Compliance with study
Item
Ability and willingness to comply with the schedule of study visits.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
Genetic diagnosis of acute promyelocytic leukemia.
boolean
C0023487 (UMLS CUI [1])
aml secondary to myelodysplastic syndrome
Item
Patients with aml secondary to myelodysplastic syndrome (mds) or chronic myeloproloferative syndrome who have been previously treated with antileukemic agents
boolean
C0280449 (UMLS CUI [1])
chemotherapy
Item
hypomethylating or standard chemotherapy.
boolean
C3665472 (UMLS CUI [1])
serum creatinine
Item
serum creatinine ≥ 250 mmol / l (≥ 2.5 mg/dl) (unless attributed to aml).
boolean
C0600061 (UMLS CUI [1])
bilirubin, alkaline phosphatase
Item
bilirubin, alkaline phosphatase or alt > 5 times the value of the upper limit of normal (unless attributed to aml) .
boolean
C0005437 (UMLS CUI [1])
C0002059 (UMLS CUI [2])
Life-threatening disease
Item
presence of an active and/or non controlled pathology different to aml which is severe and life-threatening, that in the investigator's opinion, prevents the subject participation in the study.
boolean
C1517874 (UMLS CUI [1])
concomitant disease
Item
other active concomitant malignancy or whose remission is less than one year from the screening day (except carcinoma in situ).
boolean
C0243087 (UMLS CUI [1])
Mental disorders
Item
presence of any psychiatric illness or medical condition that, in the investigator's opinion, prevents the subject participation in the study.
boolean
C0004936 (UMLS CUI [1])
life expectancy
Item
life expectancy less than x months.
boolean
C0023671 (UMLS CUI [1])
No informed consent
Item
inability of the patient or his legal representative to understand and voluntarily sign the informed consent form.
boolean
C0021430 (UMLS CUI [1])

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