Informações:
Falhas:
ID
12648
Descrição
Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia; ODM derived from: https://clinicaltrials.gov/show/NCT01251809
Link
https://clinicaltrials.gov/show/NCT01251809
Palavras-chave
Versões (1)
- 07/12/2015 07/12/2015 -
Transferido a
7 de dezembro de 2015
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukaemia NCT01251809
Eligibility Acute Lymphoblastic Leukaemia NCT01251809
- StudyEvent: Eligibility
Similar models
Eligibility Acute Lymphoblastic Leukaemia NCT01251809
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
acute lymphoblastic leukaemia
Item
previously untreated acute lymphoblastic leukaemia (pro-b, common, pre-b, early t, thymic t, mature t)
boolean
C0023449 (UMLS CUI [1])
Age
Item
age 18 years - 55 years
boolean
C0001779 (UMLS CUI [1])
treatment according to german multicenter trials for adult acute lymphoblastic leukaemia (gmall) 07/2003 protocol or subsequent gmall protocols for patients with de novo all
Item
treatment according to german multicenter trials for adult acute lymphoblastic leukaemia (gmall) 07/2003 protocol or subsequent gmall protocols for patients with de novo all
boolean
C0087111 (UMLS CUI [1])
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception
Item
women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception
boolean
C0700589 (UMLS CUI [1])
negative pregnancy test for women of child-bearing potential
Item
negative pregnancy test for women of child-bearing potential
boolean
C0032976 (UMLS CUI [1])
patients with philadelphia chromosome (bcr-abl) positive all
Item
patients with philadelphia chromosome (bcr-abl) positive all
boolean
C0031526 (UMLS CUI [1])
severe comorbidity or leukaemia-associated complications
Item
severe comorbidity or leukaemia-associated complications
boolean
C0009488 (UMLS CUI [1])
C0009566 (UMLS CUI [2])
C0009566 (UMLS CUI [2])
known hypersensitivity to asparaginase
Item
known hypersensitivity to asparaginase
boolean
C0020517 (UMLS CUI [1])
C0003993 (UMLS CUI [2])
C0003993 (UMLS CUI [2])
history of severe pancreatitis
Item
history of severe pancreatitis
boolean
C0030305 (UMLS CUI [1])
history of thrombosis or pulmonary embolism
Item
history of thrombosis or pulmonary embolism
boolean
C0034065 (UMLS CUI [1])
C0040053 (UMLS CUI [2])
C0040053 (UMLS CUI [2])
pre-existing clinically relevant coagulopathy
Item
pre-existing clinically relevant coagulopathy
boolean
C0005779 (UMLS CUI [1])
liver dysfunction
Item
liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease
boolean
C0086565 (UMLS CUI [1])
bilirubin
Item
bilirubin > 1.5 x upper limit norm (uln)
boolean
C1557209 (UMLS CUI [1])
other current malignancies
Item
other current malignancies
boolean
C0006826 (UMLS CUI [1])
severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
Item
severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
body mass index
Item
body mass index > 30 kg/m²
boolean
C1305855 (UMLS CUI [1])
pregnant or breast feeding
Item
known pregnancy, breast feeding
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])