ID

41117

Beschrijving

Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan; ODM derived from: https://clinicaltrials.gov/show/NCT01464411

Link

https://clinicaltrials.gov/show/NCT01464411

Trefwoorden

  1. 26-06-20 26-06-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

26 juni 2020

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Leukemia, Myelogenous, Chronic, BCR-ABL Positive NCT01464411

Eligibility Leukemia, Myelogenous, Chronic, BCR-ABL Positive NCT01464411

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed chronic myeloid leukemia in the chronic phase
Beschrijving

Leukemia, Myeloid, Chronic-Phase

Datatype

boolean

Alias
UMLS CUI [1]
C0023474
20 years old over
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status (ps) score 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function (hepatic, renal and lung)
Beschrijving

Organ function | Liver function | Renal function | Pulmonary function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0231921
signed written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
a case with the double cancer of the activity
Beschrijving

Malignant Neoplasm Double

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205173
women who are pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the case of pleural effusion clearly
Beschrijving

Pleural effusion

Datatype

boolean

Alias
UMLS CUI [1]
C0032227
patients with complications or a history of severe or uncontrolled cardiovascular failure following
Beschrijving

Complications | Failure Cardiovascular Severe | Failure Cardiovascular Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2,1]
C0231174
UMLS CUI [2,2]
C3887460
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0231174
UMLS CUI [3,2]
C3887460
UMLS CUI [3,3]
C0205318
have a myocardial infarction whithin 6 months
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
have an angina within 3 months
Beschrijving

Angina Pectoris

Datatype

boolean

Alias
UMLS CUI [1]
C0002962
have a congestive heart failure within 3 months
Beschrijving

Congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
have a qtc interval of more than 450msec at baseline
Beschrijving

Prolonged QTc interval

Datatype

boolean

Alias
UMLS CUI [1]
C1560305
a serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
Beschrijving

Disease Serious Uncontrolled | Therapy Investigational Receive Impaired

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0221099

Similar models

Eligibility Leukemia, Myelogenous, Chronic, BCR-ABL Positive NCT01464411

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myeloid, Chronic-Phase
Item
newly diagnosed chronic myeloid leukemia in the chronic phase
boolean
C0023474 (UMLS CUI [1])
Age
Item
20 years old over
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status (ps) score 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function | Liver function | Renal function | Pulmonary function
Item
adequate organ function (hepatic, renal and lung)
boolean
C0678852 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Double
Item
a case with the double cancer of the activity
boolean
C0006826 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pleural effusion
Item
the case of pleural effusion clearly
boolean
C0032227 (UMLS CUI [1])
Complications | Failure Cardiovascular Severe | Failure Cardiovascular Uncontrolled
Item
patients with complications or a history of severe or uncontrolled cardiovascular failure following
boolean
C0009566 (UMLS CUI [1])
C0231174 (UMLS CUI [2,1])
C3887460 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0231174 (UMLS CUI [3,1])
C3887460 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Myocardial Infarction
Item
have a myocardial infarction whithin 6 months
boolean
C0027051 (UMLS CUI [1])
Angina Pectoris
Item
have an angina within 3 months
boolean
C0002962 (UMLS CUI [1])
Congestive heart failure
Item
have a congestive heart failure within 3 months
boolean
C0018802 (UMLS CUI [1])
Prolonged QTc interval
Item
have a qtc interval of more than 450msec at baseline
boolean
C1560305 (UMLS CUI [1])
Disease Serious Uncontrolled | Therapy Investigational Receive Impaired
Item
a serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])

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