ID

13239

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00262314

Stichworte

  1. 25.01.16 25.01.16 -
Hochgeladen am

25. Januar 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Multiple Sclerosis NCT00262314

Eligibility Multiple Sclerosis NCT00262314

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
platelet count >100,000 cells/µl
Beschreibung

platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
granulocyte count > 2000 cells/µl
Beschreibung

granulocyte count

Datentyp

boolean

Alias
UMLS CUI [1]
C0857490
age 18-65 years
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
Beschreibung

pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
for patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of novantrone®
Beschreibung

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
signed inform consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of cardiac risk factors:
Beschreibung

cardiac risk factors

Datentyp

boolean

Alias
UMLS CUI [1]
C2024776
history of congestive heart failure
Beschreibung

congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
lvef < 50% determined by echocardiography or muga
Beschreibung

lvef

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
previous treatment with novantrone®, other anthracenediones, or anthracyclines
Beschreibung

anthracenediones, anthracyclines

Datentyp

boolean

Alias
UMLS CUI [1]
C0003174
UMLS CUI [2]
C0282564
prior mediastinal radiotherapy or total lymphoidal irradiation
Beschreibung

radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
ast, alt, bilirubin > 2x upper limits of normal
Beschreibung

bilirubin, ast, alt

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
severe untreated infection (including current urinary tract infection)
Beschreibung

infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
nursing or pregnant women)
Beschreibung

pregnant or nursing

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Ähnliche Modelle

Eligibility Multiple Sclerosis NCT00262314

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
infection
Item
severe untreated infection (including current urinary tract infection)
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
pregnant or nursing
Item
nursing or pregnant women)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video