ID

13804

Beschrijving

A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01303796

Link

https://clinicaltrials.gov/show/NCT01303796

Trefwoorden

  1. 07-03-16 07-03-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

7 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Acute Myeloid Leukemia NCT01303796

Eligibility Acute Myeloid Leukemia NCT01303796

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed aml based on who classification
Beschrijving

AML

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
Beschrijving

Age, chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0392920
ecog performance status 0-2
Beschrijving

ECOG

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal function
Beschrijving

renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
adequate liver function
Beschrijving

liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
able to swallow capsules
Beschrijving

ability to swallow capsules

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006935
UMLS CUI [1,2]
C0085732
agree to practice effective contraception
Beschrijving

contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
ability to understand and willingness to sign the informed consent form
Beschrijving

informed consent form

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
Beschrijving

APL or extramedullary tumor without bone marrow involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
UMLS CUI [2]
C1517677
UMLS CUI [3]
C1868812
having received any systemic anti-cancer therapy for aml or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding mds or mpd
Beschrijving

anti-cancer therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
known or suspected central nervous system (cns) involvement by leukemia
Beschrijving

cns leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C1332884
uncontrolled intercurrent illness
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
known hypersensitivity to decitabine
Beschrijving

hypersensitivity to decitabine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0049065
known to be hiv-positive
Beschrijving

hiv

Datatype

boolean

Alias
UMLS CUI [1]
C0019682

Similar models

Eligibility Acute Myeloid Leukemia NCT01303796

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
newly diagnosed aml based on who classification
boolean
C0023467 (UMLS CUI [1])
Age, chemotherapy
Item
age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
boolean
C0001779 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
ECOG
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
ability to swallow capsules
Item
able to swallow capsules
boolean
C0006935 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
contraception
Item
agree to practice effective contraception
boolean
C0700589 (UMLS CUI [1])
informed consent form
Item
ability to understand and willingness to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL or extramedullary tumor without bone marrow involvement
Item
aml is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
boolean
C0023487 (UMLS CUI [1])
C1517677 (UMLS CUI [2])
C1868812 (UMLS CUI [3])
anti-cancer therapy
Item
having received any systemic anti-cancer therapy for aml or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding mds or mpd
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
cns leukemia
Item
known or suspected central nervous system (cns) involvement by leukemia
boolean
C1332884 (UMLS CUI [1])
comorbidity
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1])
hypersensitivity to decitabine
Item
known hypersensitivity to decitabine
boolean
C0020517 (UMLS CUI [1,1])
C0049065 (UMLS CUI [1,2])
hiv
Item
known to be hiv-positive
boolean
C0019682 (UMLS CUI [1])

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