ID

13254

Beschrijving

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

Trefwoorden

  1. 26-01-16 26-01-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

26 januari 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

AML

Datatype

boolean

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

bone marrow blasts

Datatype

boolean

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

prior treatment for aml

Datatype

boolean

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

high-risk category

Datatype

boolean

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

ECOG

Datatype

boolean

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

renal and hepatic function

Datatype

boolean

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

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)
Beschrijving

cytogenetic profile

Datatype

boolean

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

cns leukemia

Datatype

boolean

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

deacetylase inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C1333261
impaired cardiac function
Beschrijving

cardiac function

Datatype

boolean

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

pregnancy or lactation

Datatype

boolean

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

contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0700589

Similar models

Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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