ID

12648

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.12.15 07.12.15 -
Hochgeladen am

7. Dezember 2015

DOI

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Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukaemia NCT01251809

Englisch

Eligibility Acute Lymphoblastic Leukaemia NCT01251809

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated acute lymphoblastic leukaemia (pro-b, common, pre-b, early t, thymic t, mature t)
Beschreibung

acute lymphoblastic leukaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023449
age 18 years - 55 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
written informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception
Beschreibung

women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
negative pregnancy test for women of child-bearing potential
Beschreibung

negative pregnancy test for women of child-bearing potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with philadelphia chromosome (bcr-abl) positive all
Beschreibung

patients with philadelphia chromosome (bcr-abl) positive all

Datentyp

boolean

Alias
UMLS CUI [1]
C0031526
severe comorbidity or leukaemia-associated complications
Beschreibung

severe comorbidity or leukaemia-associated complications

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009566
known hypersensitivity to asparaginase
Beschreibung

known hypersensitivity to asparaginase

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0003993
history of severe pancreatitis
Beschreibung

history of severe pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
history of thrombosis or pulmonary embolism
Beschreibung

history of thrombosis or pulmonary embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0040053
pre-existing clinically relevant coagulopathy
Beschreibung

pre-existing clinically relevant coagulopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease
Beschreibung

liver dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
bilirubin > 1.5 x upper limit norm (uln)
Beschreibung

bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C1557209
other current malignancies
Beschreibung

other current malignancies

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
Beschreibung

severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
body mass index > 30 kg/m²
Beschreibung

body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
known pregnancy, breast feeding
Beschreibung

pregnant or breast feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
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Ähnliche Modelle

Eligibility Acute Lymphoblastic Leukaemia NCT01251809

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
known hypersensitivity to asparaginase
Item
known hypersensitivity to asparaginase
boolean
C0020517 (UMLS CUI [1])
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])
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])
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])
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