Informatie:
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ID
42046
Beschrijving
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose
Link
https://clinicaltrials.gov/ct2/show/NCT01303952
Trefwoorden
Versies (3)
- 27-10-16 27-10-16 -
- 27-10-16 27-10-16 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
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15 maart 2021
DOI
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Licentie
Creative Commons BY 4.0
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End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
Similar models
End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Number of medication
Item
Nummer der Medikation
integer
C0237753 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Name of medication
Item
Name der Medikation
text
C0013227 (UMLS CUI [1])
medication dose
Item
Dosis
float
C3174092 (UMLS CUI [1])
Start of therapy
Item
Therapiestart
date
C3173309 (UMLS CUI [1])
therapy Stop date
Item
Therapieende
date
C1531784 (UMLS CUI [1])
Ongoing medication
Item
Fortgeführte Medikation
boolean
C2826666 (UMLS CUI [1])
indication for medication
Item
Indikation für Medikation
text
C2826696 (UMLS CUI [1])
Number of Adverse Event
Item
Nummer des Adverse Event
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Description of Adverse Event
Item
Beschreibung des Adverse Event
text
C0877248 (UMLS CUI [1])
Start of treatment
Item
Therapiestart
date
C3173309 (UMLS CUI [1])
End of treatment
Item
Therapieende
date
C1531784 (UMLS CUI [1])
adverse event intensity
Item
Schweregrad des Adverse Events
text
C1710066 (UMLS CUI [1])
Adverse event related to study treatment
Item
Zusammenhang zur Studienmedikation
boolean
C1510821 (UMLS CUI [1])
Action taken with study medication
Item
Änderungen an Studienmedikation vorgenommen
boolean
C1704758 (UMLS CUI [1])
Adverse event outcome
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
is the adverse event serious
Item
Liegt ein schwerwiegendes Adverse Event vor?
boolean
C1519255 (UMLS CUI [1])
Item Group
Einjahres Transfusionsgeschichte
C1519604 (UMLS CUI-1)
Date of blood transfusion
Item
Datum der Bluttransfusion
date
C1264703 (UMLS CUI [1])
Number of units
Item
Anzahl Einheiten
integer
C0086252 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
C0449961 (UMLS CUI [1,2])
Item
Irgendwelche die Transfusion begleitende Ereignisse?
integer
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
Code List
Irgendwelche die Transfusion begleitende Ereignisse?
CL Item
Nein (0)
CL Item
Ja (1)
if yes, please specify
Item
wenn ja, bitte spezifizieren
text
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
Signature date
Item
Datum Unterschrift
date
C0807937 (UMLS CUI [1])
CL Item
Nein (0)
CL Item
Ja (1)
Item Group
Studienergebnis und -abschluss
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0008972 (UMLS CUI-2)
Item
Vorzeitiger Studienabbruch
integer
C2718058 (UMLS CUI [1])
CL Item
Nein (0)
CL Item
Ja (1)
CL Item
dem Arzt (1)
CL Item
dem Patient (2)
If yes, date of the Termination:
Item
Wenn ja, Abbruchdatum:
date
C2983670 (UMLS CUI [1])
If yes, reason for the study termination
Item
Wenn ja, Grund für Studienabbruch
text
specify
Item
näher beschreiben
text
C0566251 (UMLS CUI [1,1])
C2348570 (UMLS CUI [1,2])
C2348570 (UMLS CUI [1,2])
Comments on the patient
Item
Kommentare zum Patienten
text
C0947611 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
Investigators name
Item
Name des Prüfarztes
text
C2826892 (UMLS CUI [1])
Stamp
Item
Briefmarke
text
C0032755 (UMLS CUI [1])
Signature date
Item
Datum Unterschrift
date
C0807937 (UMLS CUI [1])
CL Item
Nein (0)
CL Item
Ja (1)