ID

31748

Description

Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00880269

Link

https://clinicaltrials.gov/show/NCT00880269

Keywords

Versions (1)
  1. 9/25/18 9/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 25, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
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.

Back to model comments
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 Refractory Leukemia NCT00880269

English

Eligibility Refractory Leukemia NCT00880269

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent prior to study-specific screening procedures
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
life expectancy of ≥ 60 days
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative group (ecog) performance status ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
refractory aml with confirmed initial diagnosis of de novo aml (excluding apl) - or-
Description

Refractory AML | Diagnosis Initial AML de novo | APL Excluded

Data type

boolean

Alias
UMLS CUI [1]
C4528668
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C0023467
UMLS CUI [2,4]
C1515568
UMLS CUI [3,1]
C0023487
UMLS CUI [3,2]
C0332196
refractory aml with confirmed initial diagnosis of aml (excluding apl) secondary to ahd or mds with either condition precedent to aml (mds/ahd)
Description

Refractory AML | Diagnosis Initial AML | APL Excluded | Secondary to Hematological Disease Antecedent | Secondary to Myelodysplastic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C4528668
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C0023467
UMLS CUI [3,1]
C0023487
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C0175668
UMLS CUI [4,2]
C0018939
UMLS CUI [4,3]
C0683336
UMLS CUI [5,1]
C0175668
UMLS CUI [5,2]
C3463824
negative serum pregnancy test (within 7 days of first dose)
Description

Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0430061
negative urine pregnancy test immediately prior to first dose
Description

Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hiv
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
Description

Mental disorder Interferes with Comprehension Study Protocol | Mental disorder Interferes with Informed Consent | Mental disorder Impact Study Subject Participation Status | Mental disorder Impact Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C4049986
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C4049986
UMLS CUI [4,3]
C3274571
concurrent use of medications that might prolong the qt interval or of inducing torsade de pointes
Description

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Inducing Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205263
UMLS CUI [2,3]
C0040479
female patients who are pregnant or breast-feeding or patients of childbearing potential who are not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
Description

Pregnancy | Breast Feeding | Childbearing Potential Barrier Contraception Double Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0004764
UMLS CUI [3,3]
C0205173
UMLS CUI [3,4]
C0558080
male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment
Description

Gender Partner Childbearing Potential | Contraceptive method Double Unwilling | Condoms, Male

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0009653
patient is unable to swallow capsules
Description

Lacking Able to swallow Capsules

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0006935
patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
Description

Gastrointestinal system Impaired | Interference Digesting Panobinostat | Interference Absorption Panobinostat

Data type

boolean

Alias
UMLS CUI [1,1]
C0012240
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0868946
UMLS CUI [2,3]
C1998098
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0237442
UMLS CUI [3,3]
C1998098
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Back to the top of the page

Similar models

Eligibility Refractory Leukemia NCT00880269

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent prior to study-specific screening procedures
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of ≥ 60 days
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Refractory AML | Diagnosis Initial AML de novo | APL Excluded
Item
refractory aml with confirmed initial diagnosis of de novo aml (excluding apl) - or-
boolean
C4528668 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C0023467 (UMLS CUI [2,3])
C1515568 (UMLS CUI [2,4])
C0023487 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Refractory AML | Diagnosis Initial AML | APL Excluded | Secondary to Hematological Disease Antecedent | Secondary to Myelodysplastic syndrome
Item
refractory aml with confirmed initial diagnosis of aml (excluding apl) secondary to ahd or mds with either condition precedent to aml (mds/ahd)
boolean
C4528668 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C0023467 (UMLS CUI [2,3])
C0023487 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0175668 (UMLS CUI [4,1])
C0018939 (UMLS CUI [4,2])
C0683336 (UMLS CUI [4,3])
C0175668 (UMLS CUI [5,1])
C3463824 (UMLS CUI [5,2])
Serum pregnancy test negative
Item
negative serum pregnancy test (within 7 days of first dose)
boolean
C0430061 (UMLS CUI [1])
Urine pregnancy test negative
Item
negative urine pregnancy test immediately prior to first dose
boolean
C0430057 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Infection
Item
known hiv
boolean
C0019693 (UMLS CUI [1])
Mental disorder Interferes with Comprehension Study Protocol | Mental disorder Interferes with Informed Consent | Mental disorder Impact Study Subject Participation Status | Mental disorder Impact Follow-up
Item
psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C4049986 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C4049986 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Inducing Torsades de Pointes
Item
concurrent use of medications that might prolong the qt interval or of inducing torsade de pointes
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Barrier Contraception Double Unwilling
Item
female patients who are pregnant or breast-feeding or patients of childbearing potential who are not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Gender Partner Childbearing Potential | Contraceptive method Double Unwilling | Condoms, Male
Item
male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0700589 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0009653 (UMLS CUI [3])
Lacking Able to swallow Capsules
Item
patient is unable to swallow capsules
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
Gastrointestinal system Impaired | Interference Digesting Panobinostat | Interference Absorption Panobinostat
Item
patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
boolean
C0012240 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0868946 (UMLS CUI [2,2])
C1998098 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C0237442 (UMLS CUI [3,2])
C1998098 (UMLS CUI [3,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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