ID

14023

Description

A Safety and Efficacy Study Using Decitabine, Decitabine/Carboplatin, Decitabine/Arsenic for the Treatment of Relapsed, Refractory, and Elderly Acute Myeloid Leukemia , Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02190695

Link

https://clinicaltrials.gov/show/NCT02190695

Keywords

  1. 3/22/16 3/22/16 -
Uploaded on

March 22, 2016

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.

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 NCT02190695

Eligibility Acute Myeloid Leukemia NCT02190695

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
acute myeloid leukemia, relapsed or refractory and elderly(over 65)
Description

Acute myeloid leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023467
acute myeloid leukemia under 65 but who are unfit for conventional therapy
Description

Acute myeloid leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3839996
de novo or treated myelodysplastic syndrome, chronic myelomonocytic leukemia who are int-1or above
Description

Myelodysplastic syndrom

Data type

boolean

Patients may have prior exposure to azacitidine but no decitabine
Description

Azacitidine

Data type

boolean

Alias
UMLS CUI [1]
C0004475
Must be off all chemotherapy for 2 weeks and recovered from any toxicities unless rapidly progressive disease.
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0439577
Hydrea is permitted for first 4 cycles
Description

Hydrea

Data type

boolean

Alias
UMLS CUI [1]
C0591617
Performance 0-2 (ecog)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded)
Description

Adequate cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0438176
Pretreatment Electrocardiogram
Description

Electrocardiogram

Data type

boolean

Alias
UMLS CUI [1]
C0013798
Lab results
Description

Lab results

Data type

integer

Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina or cardiac arrhythmia
Description

Intercurrent illness

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0002965
Psychiatric illness which precludes the giving of informed consent
Description

Psychiatric illness

Data type

boolean

Alias
UMLS CUI [1]
C0004936
Informed Consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Nursing and pregnant females
Description

Pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0549206
Current uncontrolled infections
Description

uncontrolled infections

Data type

boolean

Alias
UMLS CUI [1]
C3714514
Uncontrolled intercurrent illness including , but not limited to the above list
Description

Significant Intercurrent Illness

Data type

boolean

Alias
UMLS CUI [1]
C3640977
Chronic kidney disease> stage 3
Description

Chronic kidney disease

Data type

boolean

Alias
UMLS CUI [1]
C0022661
Hiv infection
Description

HIV Infections

Data type

boolean

Alias
UMLS CUI [1]
C0019693

Similar models

Eligibility Acute Myeloid Leukemia NCT02190695

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute myeloid leukemia
Item
acute myeloid leukemia, relapsed or refractory and elderly(over 65)
boolean
C0023467 (UMLS CUI [1])
Acute myeloid leukemia
Item
acute myeloid leukemia under 65 but who are unfit for conventional therapy
boolean
C0023467 (UMLS CUI [1])
C3839996 (UMLS CUI [2])
Myelodysplastic syndrom
Item
de novo or treated myelodysplastic syndrome, chronic myelomonocytic leukemia who are int-1or above
boolean
Azacitidine
Item
Patients may have prior exposure to azacitidine but no decitabine
boolean
C0004475 (UMLS CUI [1])
Chemotherapy
Item
Must be off all chemotherapy for 2 weeks and recovered from any toxicities unless rapidly progressive disease.
boolean
C0439577 (UMLS CUI [1])
Hydrea
Item
Hydrea is permitted for first 4 cycles
boolean
C0591617 (UMLS CUI [1])
ECOG performance status
Item
Performance 0-2 (ecog)
boolean
C1520224 (UMLS CUI [1])
Adequate cardiac function
Item
Adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded)
boolean
C0438176 (UMLS CUI [1])
Electrocardiogram
Item
Pretreatment Electrocardiogram
boolean
C0013798 (UMLS CUI [1])
Item
Lab results
integer
Code List
Lab results
CL Item
Creatinine (1)
C0010294 (UMLS CUI-1)
CL Item
Total billirubine (2)
C0005437 (UMLS CUI-1)
Intercurrent illness
Item
Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina or cardiac arrhythmia
boolean
C0018801 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Psychiatric illness
Item
Psychiatric illness which precludes the giving of informed consent
boolean
C0004936 (UMLS CUI [1])
Informed Consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnant
Item
Nursing and pregnant females
boolean
C0549206 (UMLS CUI [1])
uncontrolled infections
Item
Current uncontrolled infections
boolean
C3714514 (UMLS CUI [1])
Significant Intercurrent Illness
Item
Uncontrolled intercurrent illness including , but not limited to the above list
boolean
C3640977 (UMLS CUI [1])
Chronic kidney disease
Item
Chronic kidney disease> stage 3
boolean
C0022661 (UMLS CUI [1])
HIV Infections
Item
Hiv infection
boolean
C0019693 (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