ID

13706

Description

Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00636922

Link

https://clinicaltrials.gov/show/NCT00636922

Keywords

Versions (1)
  1. 2/29/16 2/29/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 29, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00636922

English

Eligibility Acute Myeloid Leukemia NCT00636922

1 forms  
Criteria
Description

Criteria

no prior failure to achieve at least a pr with azacitidine or everolimus
Description

no prior failure to achieve at least a pr with azacitidine or everolimus

Data type

boolean

Alias
UMLS CUI [1]
C0004475
UMLS CUI [2]
C0541315
provision of written informed consent
Description

provision of written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
secondary aml (including therapy-related) are included
Description

secondary aml (including therapy-related) are included

Data type

boolean

Alias
UMLS CUI [1]
C0280449
life expectancy of greater than 3 months in relation to diseases other then aml/mds
Description

life expectancy of greater than 3 months in relation to diseases other then aml/mds

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0 - 3
Description

ecog performance status 0 - 3

Data type

boolean

Alias
UMLS CUI [1]
C1520224
electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (wnl) or easily correctable with supplements
Description

electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (wnl) or easily correctable with supplements

Data type

boolean

Alias
UMLS CUI [1]
C0013832
adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln
Description

adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
adequate renal function, with serum creatinine ≤ 1.5 x uln or gfr > 30 ml/minute
Description

adequate renal function, with serum creatinine ≤ 1.5 x uln or gfr > 30 ml/minute

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0017654
patients with no uncontrolled active infection
Description

patients with no uncontrolled active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
hydroxyurea ceased 48 hours prior to study therapy
Description

hydroxyurea ceased 48 hours prior to study therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020402
UMLS CUI [1,2]
C1272693
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study
Description

any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
history of major non-compliance to medication
Description

history of major non-compliance to medication

Data type

boolean

Alias
UMLS CUI [1]
C1321605
evidence of cns leukemia
Description

evidence of cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
uncontrolled viral infection with known hiv or hepatitis type b or c
Description

uncontrolled viral infection with known hiv or hepatitis type b or c

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
Description

currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication

Data type

boolean

Alias
UMLS CUI [1]
C0009488
any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol
Description

any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose
Description

males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose

Data type

boolean

Alias
UMLS CUI [1]
C0700589
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Similar models

Eligibility Acute Myeloid Leukemia NCT00636922

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
no prior failure to achieve at least a pr with azacitidine or everolimus
Item
no prior failure to achieve at least a pr with azacitidine or everolimus
boolean
C0004475 (UMLS CUI [1])
C0541315 (UMLS CUI [2])
provision of written informed consent
Item
provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
secondary aml
Item
secondary aml (including therapy-related) are included
boolean
C0280449 (UMLS CUI [1])
life expectancy
Item
life expectancy of greater than 3 months in relation to diseases other then aml/mds
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
ecog performance status 0 - 3
boolean
C1520224 (UMLS CUI [1])
electrolytes
Item
electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (wnl) or easily correctable with supplements
boolean
C0013832 (UMLS CUI [1])
hepatic function
Item
adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (uln) and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
adequate renal function
Item
adequate renal function, with serum creatinine ≤ 1.5 x uln or gfr > 30 ml/minute
boolean
C0201976 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
active infection
Item
patients with no uncontrolled active infection
boolean
C0009450 (UMLS CUI [1])
hydroxyurea
Item
hydroxyurea ceased 48 hours prior to study therapy
boolean
C0020402 (UMLS CUI [1,1])
C1272693 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study
Item
any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
compliance behavior
Item
history of major non-compliance to medication
boolean
C1321605 (UMLS CUI [1])
cns leukemia
Item
evidence of cns leukemia
boolean
C1332884 (UMLS CUI [1])
hiv or hepatitis b or c
Item
uncontrolled viral infection with known hiv or hepatitis type b or c
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
active gastrointestinal disease
Item
currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
boolean
C0009488 (UMLS CUI [1])
concurrent severe and/or uncontrolled medical conditions
Item
any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
contraception
Item
males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose
boolean
C0700589 (UMLS CUI [1])
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