ID

13717

Beschrijving

Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00761722

Link

https://clinicaltrials.gov/show/NCT00761722

Trefwoorden

Versies (1)
  1. 01-03-16 01-03-16 -
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CC BY-NC 3.0

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1 maart 2016

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00761722

Engels

Eligibility Acute Myeloid Leukemia NCT00761722

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years or older
Beschrijving

18 years or older

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of mds or cmml
Beschrijving

diagnosis of mds or cmml

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023480
diagnosis of aml, multiple myeloma, hodgkin's or non-hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
Beschrijving

diagnosis of aml, multiple myeloma, hodgkin's or non-hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0019829
UMLS CUI [4]
C0024305
ecog performance status 0-2
Beschrijving

ecog performance status 0-2

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
use of acceptable birth control
Beschrijving

use of acceptable birth control

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
standard safety inclusion for serum creatinine, ast, alt, bilirubin
Beschrijving

standard safety inclusion for serum creatinine, ast, alt, bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
serum bicarbonate greater than or equal to 20 meq/l
Beschrijving

serum bicarbonate greater than or equal to 20 meq/l

Datatype

boolean

Alias
UMLS CUI [1]
C0202059
platelet count greater than or equal to 25,000/ul
Beschrijving

platelet count greater than or equal to 25,000/ul

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
hemoglobin greater than or equal to 500/ul
Beschrijving

hemoglobin greater than or equal to 500/ul

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
signed informed consent
Beschrijving

signed informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of acute promyelocytic leukemia
Beschrijving

diagnosis of acute promyelocytic leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
treatment with demethylating agents within 21 days prior to cycle 1, day 1
Beschrijving

treatment with demethylating agents within 21 days prior to cycle 1, day 1

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
treatment with any anticancer therapy (standard or investigational) within 21 days prior to cycle 1, day 1 or ongoing adverse events from previous treatment
Beschrijving

treatment with any anticancer therapy (standard or investigational) within 21 days prior to cycle 1, day 1 or ongoing adverse events from previous treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0877248
hypersensitivity to azacitidine or mannitol
Beschrijving

hypersensitivity to azacitidine or mannitol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004475
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0024730
UMLS CUI [2,2]
C0020517
active, uncontrolled infection
Beschrijving

active, uncontrolled infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
presence of gi disease, malignant tumors or other conditions known to interfere with adme
Beschrijving

presence of gi disease, malignant tumors or other conditions known to interfere with adme

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
known or active hiv, viral hepatitis b or c
Beschrijving

known or active hiv, viral hepatitis b or c

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
breastfeeding or pregnant females
Beschrijving

breastfeeding or pregnant females

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
current or uncontrolled cardiac disease
Beschrijving

current or uncontrolled cardiac disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
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Similar models

Eligibility Acute Myeloid Leukemia NCT00761722

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
mds or cmml
Item
diagnosis of mds or cmml
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
aml, multiple myeloma, hodgkin's or non-hodgkin's lymphoma
Item
diagnosis of aml, multiple myeloma, hodgkin's or non-hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
boolean
C0023467 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0019829 (UMLS CUI [3])
C0024305 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
contraception
Item
use of acceptable birth control
boolean
C0700589 (UMLS CUI [1])
standard safety inclusion for serum creatinine, ast, alt, bilirubin
Item
standard safety inclusion for serum creatinine, ast, alt, bilirubin
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
serum bicarbonate
Item
serum bicarbonate greater than or equal to 20 meq/l
boolean
C0202059 (UMLS CUI [1])
platelet count
Item
platelet count greater than or equal to 25,000/ul
boolean
C0005821 (UMLS CUI [1])
hemoglobin
Item
hemoglobin greater than or equal to 500/ul
boolean
C0019046 (UMLS CUI [1])
signed informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
diagnosis of acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
treatment with demethylating agents
Item
treatment with demethylating agents within 21 days prior to cycle 1, day 1
boolean
C1514463 (UMLS CUI [1])
treatment with any anticancer therapy
Item
treatment with any anticancer therapy (standard or investigational) within 21 days prior to cycle 1, day 1 or ongoing adverse events from previous treatment
boolean
C0003392 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
hypersensitivity to azacitidine or mannitol
Item
hypersensitivity to azacitidine or mannitol
boolean
C0004475 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0024730 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
active infection
Item
active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
comorbidity interfering with adme
Item
presence of gi disease, malignant tumors or other conditions known to interfere with adme
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
hiv, hepatitis b or c
Item
known or active hiv, viral hepatitis b or c
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
pregnancy or breastfeeding
Item
breastfeeding or pregnant females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
current or uncontrolled cardiac disease
Item
current or uncontrolled cardiac disease
boolean
C0018799 (UMLS CUI [1])
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