ID

13726

Description

A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old; ODM derived from: https://clinicaltrials.gov/show/NCT00927498

Link

https://clinicaltrials.gov/show/NCT00927498

Keywords

Versions (1)
  1. 3/1/16 3/1/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 1, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00927498

English

Eligibility Acute Myeloid Leukemia NCT00927498

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a morphologically proven diagnosis aml and both the two following criteria: age > 50 years and £ 70 years. not previously treated for their disease.
Description

patients with a morphologically proven diagnosis aml and both the two following criteria: age > 50 years and £ 70 years. not previously treated for their disease.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0001779
ecog performance status 0 to 3
Description

ecog performance status 0 to 3

Data type

boolean

Alias
UMLS CUI [1]
C1520224
negative serology hiv, hbv and hbc (except post vaccination)
Description

negative serology hiv, hbv and hbc (except post vaccination)

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
serum creatinin inf 2.5n; ast and alt inf 2.5n; total bilirubin inf 2n
Description

serum creatinin inf 2.5n; ast and alt inf 2.5n; total bilirubin inf 2n

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
cardiac function determined by radionucleide or echography within normal limits.
Description

cardiac function determined by radionucleide or echography within normal limits.

Data type

boolean

Alias
UMLS CUI [1]
C0232164
negative serum pregnancy test within one week before treatment for women of child bearing potential.
Description

negative serum pregnancy test within one week before treatment for women of child bearing potential.

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C3831118
signed informed consent.
Description

signed informed consent.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
m3-aml
Description

m3-aml

Data type

boolean

Alias
UMLS CUI [1]
C0023487
aml following previously know myeloproliferative syndrome.
Description

aml following previously know myeloproliferative syndrome.

Data type

boolean

Alias
UMLS CUI [1]
C0280449
UMLS CUI [2,1]
C1443043
UMLS CUI [2,2]
C0332152
known central nervous system involvement.
Description

known central nervous system involvement.

Data type

boolean

Alias
UMLS CUI [1]
C0449389
uncontrolled infection
Description

uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
other active malignancy
Description

other active malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Acute Myeloid Leukemia NCT00927498

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML, age
Item
patients with a morphologically proven diagnosis aml and both the two following criteria: age > 50 years and £ 70 years. not previously treated for their disease.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
ecog
Item
ecog performance status 0 to 3
boolean
C1520224 (UMLS CUI [1])
hiv, hbv, hbc
Item
negative serology hiv, hbv and hbc (except post vaccination)
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
creatinine, ast, alt, bilirubin
Item
serum creatinin inf 2.5n; ast and alt inf 2.5n; total bilirubin inf 2n
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
cardiac function
Item
cardiac function determined by radionucleide or echography within normal limits.
boolean
C0232164 (UMLS CUI [1])
pregnancy test for women of childbearing potential
Item
negative serum pregnancy test within one week before treatment for women of child bearing potential.
boolean
C0032976 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
signed informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
m3-aml
Item
m3-aml
boolean
C0023487 (UMLS CUI [1])
aml following previously know myeloproliferative syndrome
Item
aml following previously know myeloproliferative syndrome.
boolean
C0280449 (UMLS CUI [1])
C1443043 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
cns involvement
Item
known central nervous system involvement.
boolean
C0449389 (UMLS CUI [1])
uncontrolled infection
Item
uncontrolled infection
boolean
C0009488 (UMLS CUI [1])
other active malignancy
Item
other active malignancy
boolean
C0006826 (UMLS CUI [1])
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