ID

14944

Beschrijving

Efficacy and Safety of Imatinib Mesylate as First-line Treatment for the Patients With Chronic Phase of Chronic Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02317159

Link

https://clinicaltrials.gov/show/NCT02317159

Trefwoorden

Versies (1)
  1. 09-05-16 09-05-16 -
Geüploaded op

9 mei 2016

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia NCT02317159

Engels

Eligibility Chronic Myeloid Leukemia NCT02317159

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age≥18；
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the new diagnosis of cml patients in six months；
Beschrijving

Myeloid Leukemia, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0023473
no proof of extra-medullary infiltration of leukemia；
Beschrijving

Leukaemic infiltration extramedullary

Datatype

boolean

Alias
UMLS CUI [1]
C1868812
ecog ps score：0-2；
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
hepatic and renal functions are normal，serum bilirubin≤1.5*uln, serum alt and ast≤2.5*uln, serum cr≤1.5*uln;
Beschrijving

Liver function normal | Normal renal function | Serum total bilirubin measurement | Serum Alanine Transaminase tests | AST serum measurement | Creatinine measurement, serum | Upper Limit of Normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0232805
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0036828
UMLS CUI [5]
C1261155
UMLS CUI [6]
C0201976
UMLS CUI [7]
C1519815
do not receive the treatment of anti-cml；
Beschrijving

Therapeutic procedure Against Chronic Myeloid Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0023473
subjects signed informed consent form in line with gcp requirements。
Beschrijving

Informed Consent | Good Clinical Practice Requirement

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C2986419
UMLS CUI [2,2]
C1514873
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women；
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
received tkis any time before；
Beschrijving

Tyrosine kinase inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C1268567
failure to control systemic infection or multiple organ failure；
Beschrijving

Sepsis Control Unsuccessful | Multiple Organ Failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C1272705
UMLS CUI [2]
C0026766
according to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
Beschrijving

Comorbidity Affecting Patient safety | Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
being diagnosed with other malignancies in the prior 12 months；
Beschrijving

Malignant Neoplasms Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
have a history of neurological or psychiatric disorders, including epilepsy or dementia；
Beschrijving

nervous system disorder | Mental disorders | Epilepsy | Dementia

Datatype

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0497327
known or suspected allergy to imatinib；
Beschrijving

Hypersensitivity imatinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0935989
bsa≤1.5m2；
Beschrijving

Body Surface Area

Datatype

boolean

Alias
UMLS CUI [1]
C0005902
using other experimental drugs or participating in other clinical trials in the prior one months。
Beschrijving

Investigational New Drugs Other | Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348568
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Similar models

Eligibility Chronic Myeloid Leukemia NCT02317159

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age≥18；
boolean
C0001779 (UMLS CUI [1])
Myeloid Leukemia, Chronic
Item
the new diagnosis of cml patients in six months；
boolean
C0023473 (UMLS CUI [1])
Leukaemic infiltration extramedullary
Item
no proof of extra-medullary infiltration of leukemia；
boolean
C1868812 (UMLS CUI [1])
ECOG performance status
Item
ecog ps score：0-2；
boolean
C1520224 (UMLS CUI [1])
Liver function normal | Normal renal function | Serum total bilirubin measurement | Serum Alanine Transaminase tests | AST serum measurement | Creatinine measurement, serum | Upper Limit of Normal
Item
hepatic and renal functions are normal，serum bilirubin≤1.5*uln, serum alt and ast≤2.5*uln, serum cr≤1.5*uln;
boolean
C0232741 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0232805 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0036828 (UMLS CUI [4])
C1261155 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C1519815 (UMLS CUI [7])
Therapeutic procedure Against Chronic Myeloid Leukemia
Item
do not receive the treatment of anti-cml；
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0023473 (UMLS CUI [1,3])
Informed Consent | Good Clinical Practice Requirement
Item
subjects signed informed consent form in line with gcp requirements。
boolean
C0021430 (UMLS CUI [1])
C2986419 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women；
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tyrosine kinase inhibitor
Item
received tkis any time before；
boolean
C1268567 (UMLS CUI [1])
Sepsis Control Unsuccessful | Multiple Organ Failure
Item
failure to control systemic infection or multiple organ failure；
boolean
C0243026 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0026766 (UMLS CUI [2])
Comorbidity Affecting Patient safety | Compliance behavior Limited
Item
according to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study；
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Malignant Neoplasms Other
Item
being diagnosed with other malignancies in the prior 12 months；
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
nervous system disorder | Mental disorders | Epilepsy | Dementia
Item
have a history of neurological or psychiatric disorders, including epilepsy or dementia；
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
Hypersensitivity imatinib
Item
known or suspected allergy to imatinib；
boolean
C0020517 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Body Surface Area
Item
bsa≤1.5m2；
boolean
C0005902 (UMLS CUI [1])
Investigational New Drugs Other | Study Subject Participation Status
Item
using other experimental drugs or participating in other clinical trials in the prior one months。
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
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