ID

13254

Description

Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01242774

Link

https://clinicaltrials.gov/show/NCT01242774

Keywords

  1. 1/26/16 1/26/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 26, 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 (AML) NCT01242774

Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk aml
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
= 20% bone marrow blasts via bone marrow aspiration or biopsy
Description

bone marrow blasts

Data type

boolean

Alias
UMLS CUI [1]
C0368761
the patient has not yet been treated for aml
Description

prior treatment for aml

Data type

boolean

Alias
UMLS CUI [1]
C0087111
1º or 2º aml patients with high-risk category features
Description

high-risk category

Data type

boolean

Alias
UMLS CUI [1]
C0086930
ecog ps = 2
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
renal function and liver function limits.
Description

renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
Description

cytogenetic profile

Data type

boolean

Alias
UMLS CUI [1]
C0010802
patient has clinical symptoms suggestive of cns leukemia and/or csf findings for cns leukemia
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
prior treatment with deacetylase inhibitors (daci) including, panobinostat
Description

deacetylase inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1333261
impaired cardiac function
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
female patient who is pregnant or breast feeding
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male patient who is not willing to use a barrier method of contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589

Similar models

Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk aml
boolean
C0023467 (UMLS CUI [1])
bone marrow blasts
Item
= 20% bone marrow blasts via bone marrow aspiration or biopsy
boolean
C0368761 (UMLS CUI [1])
prior treatment for aml
Item
the patient has not yet been treated for aml
boolean
C0087111 (UMLS CUI [1])
high-risk category
Item
1º or 2º aml patients with high-risk category features
boolean
C0086930 (UMLS CUI [1])
ECOG
Item
ecog ps = 2
boolean
C1520224 (UMLS CUI [1])
renal and hepatic function
Item
renal function and liver function limits.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
cytogenetic profile
Item
patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
boolean
C0010802 (UMLS CUI [1])
cns leukemia
Item
patient has clinical symptoms suggestive of cns leukemia and/or csf findings for cns leukemia
boolean
C1332884 (UMLS CUI [1])
deacetylase inhibitors
Item
prior treatment with deacetylase inhibitors (daci) including, panobinostat
boolean
C1333261 (UMLS CUI [1])
cardiac function
Item
impaired cardiac function
boolean
C0232164 (UMLS CUI [1])
pregnancy or lactation
Item
female patient who is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraception
Item
male patient who is not willing to use a barrier method of contraception
boolean
C0700589 (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