ID

13749

Beschrijving

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01074047

Link

https://clinicaltrials.gov/show/NCT01074047

Trefwoorden

Versies (1)
  1. 02-03-16 02-03-16 -
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2 maart 2016

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Eligibility Acute Myeloid Leukemia NCT01074047

Engels

Eligibility Acute Myeloid Leukemia NCT01074047

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of one of the following
Beschrijving

ID.1

Datatype

boolean

newly diagnosed de novo acute myeloid leukemia (aml)
Beschrijving

newly diagnosed de novo acute myeloid leukemia (aml)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
aml secondary to myelodysplastic syndromes (mds)
Beschrijving

aml secondary to myelodysplastic syndromes (mds)

Datatype

boolean

Alias
UMLS CUI [1]
C0280449
UMLS CUI [2]
C3463824
aml secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
Beschrijving

aml secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years

Datatype

boolean

Alias
UMLS CUI [1]
C0280449
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2983796
bone marrow blasts >30%
Beschrijving

bone marrow blasts >30%

Datatype

boolean

Alias
UMLS CUI [1]
C1982687
age ≥ 65 years
Beschrijving

age ≥ 65 years

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
easter cooperative oncology group (ecog) 0-2
Beschrijving

easter cooperative oncology group (ecog) 0-2

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous cytotoxic or biologic treatment for aml (except hydroxyurea)
Beschrijving

previous cytotoxic or biologic treatment for aml (except hydroxyurea)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1514463
UMLS CUI [2]
C0020402
previous treatment with azacitidine, decitabine or cytarabine
Beschrijving

previous treatment with azacitidine, decitabine or cytarabine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004475
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0049065
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C0010711
UMLS CUI [3,2]
C1514463
prior use of targeted therapy agents (e.g., flt3 inhibitors, other kinase inhibitors)
Beschrijving

prior use of targeted therapy agents (e.g., flt3 inhibitors, other kinase inhibitors)

Datatype

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C1514463
aml french american british subtype (fab m3)
Beschrijving

aml french american british subtype (fab m3)

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
aml associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
Beschrijving

aml associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0008625
prior bone marrow or stem cell transplantation
Beschrijving

prior bone marrow or stem cell transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005961
UMLS CUI [1,2]
C0332152
UMLS CUI [2,1]
C1504389
UMLS CUI [2,2]
C0332152
candidate for allogeneic bone marrow or stem cell transplant
Beschrijving

candidate for allogeneic bone marrow or stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1504389
diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
Beschrijving

diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
malignant hepatic tumors
Beschrijving

malignant hepatic tumors

Datatype

boolean

Alias
UMLS CUI [1]
C0345904
uncontrolled systemic infection
Beschrijving

uncontrolled systemic infection

Datatype

boolean

Alias
UMLS CUI [1]
C3646020
active viral infection with human immunodeficiency virus (hiv) or hepatitis type b or c
Beschrijving

active viral infection with human immunodeficiency virus (hiv) or hepatitis type b or c

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
use of any experimental drug or therapy within 28 days prior to day 1
Beschrijving

use of any experimental drug or therapy within 28 days prior to day 1

Datatype

boolean

Alias
UMLS CUI [1]
C0304229
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Similar models

Eligibility Acute Myeloid Leukemia NCT01074047

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of one of the following
boolean
de novo aml
Item
newly diagnosed de novo acute myeloid leukemia (aml)
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
secondary AML
Item
aml secondary to myelodysplastic syndromes (mds)
boolean
C0280449 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
secondary aml to leukemogenic therapy
Item
aml secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
boolean
C0280449 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2983796 (UMLS CUI [2,2])
bone marrow blasts
Item
bone marrow blasts >30%
boolean
C1982687 (UMLS CUI [1])
age
Item
age ≥ 65 years
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
easter cooperative oncology group (ecog) 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior therapy for aml
Item
previous cytotoxic or biologic treatment for aml (except hydroxyurea)
boolean
C0023467 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0020402 (UMLS CUI [2])
previous treatment with azacitidine, decitabine or cytarabine
Item
previous treatment with azacitidine, decitabine or cytarabine
boolean
C0004475 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0049065 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0010711 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
prior use of targeted therapy agents
Item
prior use of targeted therapy agents (e.g., flt3 inhibitors, other kinase inhibitors)
boolean
C2985566 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
AML m3
Item
aml french american british subtype (fab m3)
boolean
C0023487 (UMLS CUI [1])
aml cytogenetics
Item
aml associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
boolean
C0023467 (UMLS CUI [1,1])
C0008625 (UMLS CUI [1,2])
prior bone marrow or stem cell transplantation
Item
prior bone marrow or stem cell transplantation
boolean
C0005961 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
candidate for allogeneic bone marrow or stem cell transplant
Item
candidate for allogeneic bone marrow or stem cell transplant
boolean
C0005961 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
malignant disease
Item
diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
boolean
C0006826 (UMLS CUI [1])
malignant neoplasm of the liver
Item
malignant hepatic tumors
boolean
C0345904 (UMLS CUI [1])
uncontrolled systemic infection
Item
uncontrolled systemic infection
boolean
C3646020 (UMLS CUI [1])
hiv, hepatitis b or c
Item
active viral infection with human immunodeficiency virus (hiv) or hepatitis type b or c
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
experimental drug use
Item
use of any experimental drug or therapy within 28 days prior to day 1
boolean
C0304229 (UMLS CUI [1])
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