ID

13717

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00761722

Nyckelord

Versioner (1)
  1. 2016-03-01 2016-03-01 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

1 mars 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Acute Myeloid Leukemia NCT00761722

Engelsk

Eligibility Acute Myeloid Leukemia NCT00761722

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years or older
Beskrivning

18 years or older

Datatyp

boolean

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

diagnosis of mds or cmml

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

ecog performance status 0-2

Datatyp

boolean

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

use of acceptable birth control

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

serum bicarbonate greater than or equal to 20 meq/l

Datatyp

boolean

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

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

Datatyp

boolean

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

hemoglobin greater than or equal to 500/ul

Datatyp

boolean

Alias
UMLS CUI [1]
C0019046
signed informed consent
Beskrivning

signed informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of acute promyelocytic leukemia
Beskrivning

diagnosis of acute promyelocytic leukemia

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

hypersensitivity to azacitidine or mannitol

Datatyp

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
Beskrivning

active, uncontrolled infection

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

known or active hiv, viral hepatitis b or c

Datatyp

boolean

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

breastfeeding or pregnant females

Datatyp

boolean

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

current or uncontrolled cardiac disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
Tillbaka till toppen

Similar models

Eligibility Acute Myeloid Leukemia NCT00761722

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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