Information:
Error:
ID
12797
Description
Glivec in Ph Positive Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00388895
Link
https://clinicaltrials.gov/show/NCT00388895
Keywords
Versions (1)
- 12/21/15 12/21/15 -
Uploaded on
December 21, 2015
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Acute Lymphoblastic Leukemia NCT00388895
Eligibility Acute Lymphoblastic Leukemia NCT00388895
- StudyEvent: Eligibility
Similar models
Eligibility Acute Lymphoblastic Leukemia NCT00388895
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
all ph+
Item
new diagnosis all ph+ (bcr/abl) patients ≤ 65 years old
boolean
C1960397 (UMLS CUI [1])
pregnancy test negative
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 percent; 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 negative
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 surgical process in the previous 14 days
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])
all
Item
other all variability
boolean
C0023449 (UMLS CUI [1])
previous history of coronary valvular, hypertensive cardiopathy illness
Item
previous history of coronary valvular, hypertensive cardiopathy illness
boolean
C0010068 (UMLS CUI [1])
C3258293 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C3258293 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
chronic hepatic disease
Item
chronic hepatic illness
boolean
C0341439 (UMLS CUI [1])
chronic respiratory insufficiency
Item
chronic respiratory insufficiency
boolean
C1998122 (UMLS CUI [1])
renal insufficiency
Item
renal insufficiency not caused by lla
boolean
C1565489 (UMLS CUI [1])
neurological problems
Item
severe neurological problems not caused by lla
boolean
C0221571 (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 women
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
blastic crisis cml
Item
blastic crisis cml
boolean
C0687162 (UMLS CUI [1])