Information:
Fel:
ID
12785
Beskrivning
Glivec in Ph Positive Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00388895
Länk
https://clinicaltrials.gov/show/NCT00388895
Nyckelord
Versioner (1)
- 2015-12-21 2015-12-21 -
Uppladdad den
21 december 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00388895
Eligibility Acute Lymphoblastic Leukemia NCT00388895
- StudyEvent: Eligibility
Similar models
Eligibility Acute Lymphoblastic Leukemia NCT00388895
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
new diagnosis lla ph+ (bcr/abl) patients ≤65 years old
Item
new diagnosis lla ph+ (bcr/abl) patients ≤65 years old
boolean
C0079011 (UMLS CUI [1])
C1960397 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1960397 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
negative pregnancy test
Item
fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
boolean
C0427780 (UMLS CUI [1])
Ecog performance status
Item
performance status 0-2 (appendix b); is allowed performance status > 2 because of lla
boolean
C1520224 (UMLS CUI [1])
patients without organ alteration
Item
patients without organ alteration: hepatic function: global bilirubin, ast, alt, gamma-gt and alkaline phosphatase less than 2 times lsn; renal function: creatinine < 1,5 mg/dl o clearance creatinine > 60 ml/min; anormal renal function caused by lla ; normal heart function (appendix b): fev > 50%; no chronic respiratory illness. if the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
hiv negativ
Item
negative hiv serology
boolean
C0481430 (UMLS CUI [1])
informed consent
Item
written, oral or with witness informed consent. in patients < 18 years old must be signed written and legal representative informed consent.
boolean
C0021430 (UMLS CUI [1])
no experimental chemotherapy or other experimental treatment no major surgery
Item
no experimental chemotherapy or other experimental treatment. allowed to begin induction chemotherapy from the diagnosis to confirm ph. no major surgical process in the previous 14 days of the treatment start.
boolean
C2348568 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0679637 (UMLS CUI [2])
other
Item
other lla variability
boolean
C0205394 (UMLS CUI [1])
hypertensive disease or valvular disease
Item
previous history of coronary valvular, hypertensive cardiopathy illness
boolean
C3258293 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0020538 (UMLS CUI [2])
chronic hepatic disease
Item
chronic hepatic illness
boolean
C0023895 (UMLS CUI [1])
respiratory insufficiency
Item
chronic respiratory insufficiency
boolean
C0035229 (UMLS CUI [1])
renal failure
Item
renal insufficiency not caused by lla
boolean
C0035078 (UMLS CUI [1])
neurological disease
Item
severe neurological problems not caused by lla
boolean
C0027765 (UMLS CUI [1])
Ecog performance status
Item
severe affection of the performance status (grade 3-4 oms gradation) not caused by lla
boolean
C1520224 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnancy and breastfeeding
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
blastic crisis cml
Item
blastic crisis cml
boolean
C0687162 (UMLS CUI [1])