ID

13804

Description

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

Keywords

  1. 3/7/16 3/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 7, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Acute Myeloid Leukemia NCT01303796

Eligibility Acute Myeloid Leukemia NCT01303796

Inclusion Criteria
Description

Inclusion Criteria

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

AML

Data type

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
Description

Age, chemotherapy

Data type

boolean

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

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal function
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
adequate liver function
Description

liver function

Data type

boolean

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

ability to swallow capsules

Data type

boolean

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

contraception

Data type

boolean

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

informed consent form

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

APL or extramedullary tumor without bone marrow involvement

Data type

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
Description

anti-cancer therapy

Data type

boolean

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

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
uncontrolled intercurrent illness
Description

comorbidity

Data type

boolean

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

hypersensitivity to decitabine

Data type

boolean

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

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682

Similar models

Eligibility Acute Myeloid Leukemia NCT01303796

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial