ID

13706

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00636922

Trefwoorden

Versies (1)
  1. 29-02-16 29-02-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

29 februari 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.

Terug naar het model Commentaren
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 NCT00636922

Engels

Eligibility Acute Myeloid Leukemia NCT00636922

1 Formulieren  
Criteria
Beschrijving

Criteria

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

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

Datatype

boolean

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

provision of written informed consent

Datatype

boolean

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

secondary aml (including therapy-related) are included

Datatype

boolean

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

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

Datatype

boolean

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

ecog performance status 0 - 3

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

boolean

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

patients with no uncontrolled active infection

Datatype

boolean

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

hydroxyurea ceased 48 hours prior to study therapy

Datatype

boolean

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

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
Beschrijving

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

Datatype

boolean

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

history of major non-compliance to medication

Datatype

boolean

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

evidence of cns leukemia

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
Terug naar het begin van de pagina

Similar models

Eligibility Acute Myeloid Leukemia NCT00636922

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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