Information:
Fel:
ID
13239
Beskrivning
Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00262314
Länk
https://clinicaltrials.gov/show/NCT00262314
Nyckelord
Versioner (1)
- 2016-01-25 2016-01-25 -
Uppladdad den
25 januari 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00262314
Eligibility Multiple Sclerosis NCT00262314
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis NCT00262314
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
platelet count
Item
platelet count >100,000 cells/µl
boolean
C0032181 (UMLS CUI [1])
granulocyte count
Item
granulocyte count > 2000 cells/µl
boolean
C0857490 (UMLS CUI [1])
age
Item
age 18-65 years
boolean
C0001779 (UMLS CUI [1])
pregnancy test
Item
negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
boolean
C0032976 (UMLS CUI [1])
contraception
Item
for patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of novantrone®
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
signed inform consent.
boolean
C0021430 (UMLS CUI [1])
cardiac risk factors
Item
presence of cardiac risk factors:
boolean
C2024776 (UMLS CUI [1])
congestive heart failure
Item
history of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
lvef
Item
lvef < 50% determined by echocardiography or muga
boolean
C0428772 (UMLS CUI [1])
anthracenediones, anthracyclines
Item
previous treatment with novantrone®, other anthracenediones, or anthracyclines
boolean
C0003174 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
C0282564 (UMLS CUI [2])
radiotherapy
Item
prior mediastinal radiotherapy or total lymphoidal irradiation
boolean
C1522449 (UMLS CUI [1])
bilirubin, ast, alt
Item
ast, alt, bilirubin > 2x upper limits of normal
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
infection
Item
severe untreated infection (including current urinary tract infection)
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
pregnant or nursing
Item
nursing or pregnant women)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])