ID

13717

Description

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

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 NCT00761722

English

Eligibility Acute Myeloid Leukemia NCT00761722

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years or older
Description

18 years or older

Data type

boolean

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

diagnosis of mds or cmml

Data type

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
Description

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

Data type

boolean

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

ecog performance status 0-2

Data type

boolean

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

use of acceptable birth control

Data type

boolean

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

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

Data type

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
Description

serum bicarbonate greater than or equal to 20 meq/l

Data type

boolean

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

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

Data type

boolean

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

hemoglobin greater than or equal to 500/ul

Data type

boolean

Alias
UMLS CUI [1]
C0019046
signed informed consent
Description

signed informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of acute promyelocytic leukemia
Description

diagnosis of acute promyelocytic leukemia

Data type

boolean

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

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

Data type

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
Description

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

Data type

boolean

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

hypersensitivity to azacitidine or mannitol

Data type

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
Description

active, uncontrolled infection

Data type

boolean

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

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

Data type

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
Description

known or active hiv, viral hepatitis b or c

Data type

boolean

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

breastfeeding or pregnant females

Data type

boolean

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

current or uncontrolled cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
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Similar models

Eligibility Acute Myeloid Leukemia NCT00761722

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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