ID

13748

Beskrivning

ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01067274

Länk

https://clinicaltrials.gov/show/NCT01067274

Nyckelord

Versioner (1)
  1. 2016-03-02 2016-03-02 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

2 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01067274

Engelsk

Eligibility Acute Myeloid Leukemia NCT01067274

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged of 65 to 79 years
Beskrivning

1. aged of 65 to 79 years

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"
Beskrivning

2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [2]
C2825139
3. not previously treated for aml
Beskrivning

3. not previously treated for aml

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332154
4. signed informed consent.
Beskrivning

4. signed informed consent.

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. apl in the who classification.
Beskrivning

1. apl in the who classification.

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
2. ph1-positive aml or prior ph1-positive disease
Beskrivning

ID.6

Datatyp

boolean

3. aml evolving from a prior mpn in the who 2008 classification.
Beskrivning

3. aml evolving from a prior mpn in the who 2008 classification.

Datatyp

boolean

Alias
UMLS CUI [1]
C0280449
4. prior treatment with chemotherapy or radiotherapy for another tumor
Beskrivning

4. prior treatment with chemotherapy or radiotherapy for another tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
Beskrivning

5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332152
UMLS CUI [2]
C0007099
UMLS CUI [3]
C0699893
6. prior advanced malignant hepatic tumor
Beskrivning

6. prior advanced malignant hepatic tumor

Datatyp

boolean

Alias
UMLS CUI [1]
C0345904
7. ecog performance status score > 2
Beskrivning

7. ecog performance status score > 2

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.
Beskrivning

8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.
Beskrivning

9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
10. ast (sgot) or alt (sgpt) more than 2.5x's the uln at the laboratory where the analysis was performed, except if aml-related
Beskrivning

AST or ALT

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
11. lvef less than.55 or equivalent by doppler echocardiography
Beskrivning

11. lvef less than.55 or equivalent by doppler echocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
12. known intolerance to azacitidine, mannitol, retinoids
Beskrivning

12. known intolerance to azacitidine, mannitol, retinoids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004475
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0024730
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C0035339
UMLS CUI [3,2]
C0020517
13. positive serum test for hiv and htlv-1
Beskrivning

13. positive serum test for hiv and htlv-1

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0020094
14. nyha grade 3/4 cardiac disease .
Beskrivning

14. nyha grade 3/4 cardiac disease .

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
15. severe infection at inclusion time.
Beskrivning

15. severe infection at inclusion time.

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
Beskrivning

16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
17. absence of health care insurance (affiliation à un régime de sécurité sociale)
Beskrivning

17. absence of health care insurance (affiliation à un régime de sécurité sociale)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C0332197
18. participation to any study requiring informed consent
Beskrivning

18. participation to any study requiring informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Acute Myeloid Leukemia NCT01067274

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. aged of 65 to 79 years
boolean
C0001779 (UMLS CUI [1])
AML de novo or AML with myelodysplasia related changes
Item
2. with a morphologically proven diagnosis of aml according to who classification either de novo or aml with "myelodysplasia related changes"
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C2825139 (UMLS CUI [2])
AML not previously treated
Item
3. not previously treated for aml
boolean
C0023467 (UMLS CUI [1,1])
C0332154 (UMLS CUI [1,2])
signed informed consent
Item
4. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
1. apl in the who classification.
boolean
C0023487 (UMLS CUI [1])
ID.6
Item
2. ph1-positive aml or prior ph1-positive disease
boolean
aml evolving from a prior mpn
Item
3. aml evolving from a prior mpn in the who 2008 classification.
boolean
C0280449 (UMLS CUI [1])
prior chemotherapy or radiotherapy
Item
4. prior treatment with chemotherapy or radiotherapy for another tumor
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
prior malignancy
Item
5. prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
boolean
C0006826 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0007099 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
hepatic malignancy
Item
6. prior advanced malignant hepatic tumor
boolean
C0345904 (UMLS CUI [1])
ECOG
Item
7. ecog performance status score > 2
boolean
C1520224 (UMLS CUI [1])
creatinine
Item
8. creatinine level more than 2x's the upper limit of the normal range (uln) at the laboratory where the analysis was performed, except if aml-related.
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
9. total serum bilirubin more than 2x's the uln at the laboratory where the analysis was performed, except if aml-related.
boolean
C1278039 (UMLS CUI [1])
AST or ALT
Item
10. ast (sgot) or alt (sgpt) more than 2.5x's the uln at the laboratory where the analysis was performed, except if aml-related
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
LVEF
Item
11. lvef less than.55 or equivalent by doppler echocardiography
boolean
C0428772 (UMLS CUI [1])
intolerance to azacitidine, mannitol, retinoids
Item
12. known intolerance to azacitidine, mannitol, retinoids
boolean
C0004475 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0024730 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0035339 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
hiv and htlv-1
Item
13. positive serum test for hiv and htlv-1
boolean
C0019682 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
NYHA
Item
14. nyha grade 3/4 cardiac disease .
boolean
C1275491 (UMLS CUI [1])
infection
Item
15. severe infection at inclusion time.
boolean
C0009450 (UMLS CUI [1])
comorbidity limiting compliance
Item
16. psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
absence of health care insurance
Item
17. absence of health care insurance (affiliation à un régime de sécurité sociale)
boolean
C0021682 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
participation to any study requiring informed consent
Item
18. participation to any study requiring informed consent
boolean
C2348568 (UMLS CUI [1])
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