ID

42046

Descripción

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

Palabras clave

Versiones (3)
  1. 27/10/16 27/10/16 -
  2. 27/10/16 27/10/16 -
  3. 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Subido en

15 de marzo de 2021

DOI

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Licencia

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

Alemán Inglés

End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 formularios  
Medikation
Descripción

Medikation

Alias
UMLS CUI-1
C0013227
Nummer der Medikation
Descripción

Number of medication

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0013227
Name der Medikation
Descripción

Name of medication

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Dosis
Descripción

medication dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Therapiestart
Descripción

Start of therapy

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Therapieende
Descripción

therapy Stop date

Tipo de datos

date

Alias
UMLS CUI [1]
C1531784
Fortgeführte Medikation
Descripción

Ongoing medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
Indikation für Medikation
Descripción

indication for medication

Tipo de datos

text

Alias
UMLS CUI [1]
C2826696
Adverse Events
Descripción

Adverse Events

Alias
UMLS CUI-1
C0877248
Nummer des Adverse Event
Descripción

Number of Adverse Event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Beschreibung des Adverse Event
Descripción

Description of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Therapiestart
Descripción

Start of treatment

Tipo de datos

date

Alias
UMLS CUI [1]
C3173309
Therapieende
Descripción

End of treatment

Tipo de datos

date

Alias
UMLS CUI [1]
C1531784
Schweregrad des Adverse Events
Descripción

adverse event intensity

Tipo de datos

text

Alias
UMLS CUI [1]
C1710066
Zusammenhang zur Studienmedikation
Descripción

Adverse event related to study treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1510821
Änderungen an Studienmedikation vorgenommen
Descripción

Action taken with study medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1704758
Adverse Event Outcome
Descripción

Adverse event outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Liegt ein schwerwiegendes Adverse Event vor?
Descripción

is the adverse event serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Einjahres Transfusionsgeschichte
Descripción

Einjahres Transfusionsgeschichte

Alias
UMLS CUI-1
C1519604
Datum der Bluttransfusion
Descripción

Date of blood transfusion

Tipo de datos

date

Unidades de medida
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1264703
YYYY-MM-DD
Anzahl Einheiten
Descripción

Number of units

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0449961
Irgendwelche die Transfusion begleitende Ereignisse?
Descripción

Any special events circumstances transfusion?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1879316
wenn ja, bitte spezifizieren
Descripción

if yes, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1879316
Datum Unterschrift
Descripción

Signature date

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
Unterschrift Prüfarzt
Descripción

Investigators signature

Tipo de datos

integer

Alias
UMLS CUI [1]
C2346576
Studienergebnis und -abschluss
Descripción

Studienergebnis und -abschluss

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Vorzeitiger Studienabbruch
Descripción

Early Ending of the Study or Termination

Tipo de datos

integer

Alias
UMLS CUI [1]
C2718058
Wenn ja, beendet von wem?
Descripción

If yes, study termination by?

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348570
Wenn ja, Abbruchdatum:
Descripción

If yes, date of the Termination:

Tipo de datos

date

Alias
UMLS CUI [1]
C2983670
Wenn ja, Grund für Studienabbruch
Descripción

If yes, reason for the study termination

Tipo de datos

text

näher beschreiben
Descripción

specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2348570
Kommentare zum Patienten
Descripción

Comments on the patient

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0030705
Name des Prüfarztes
Descripción

Investigators name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Briefmarke
Descripción

Stamp

Tipo de datos

text

Alias
UMLS CUI [1]
C0032755
Datum Unterschrift
Descripción

Signature date

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
Unterschrift Prüfarzt
Descripción

Investigators signature

Tipo de datos

integer

Alias
UMLS CUI [1]
C2346576
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Similar models

End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Medikation
C0013227 (UMLS CUI-1)
Number of medication
Item
Nummer der Medikation
integer
C0237753 (UMLS CUI [1,1])
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])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Number of Adverse Event
Item
Nummer des Adverse Event
integer
C0877248 (UMLS CUI [1,1])
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])
Item
Irgendwelche die Transfusion begleitende Ereignisse?
integer
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
Are all inclusion criteria fulfilled?
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])
Signature date
Item
Datum Unterschrift
date
C0807937 (UMLS CUI [1])
Item
Unterschrift Prüfarzt
integer
C2346576 (UMLS CUI [1])
Are all inclusion criteria fulfilled?
Code List
Unterschrift Prüfarzt
CL Item
Nein (0)
CL Item
Ja (1)
Item Group
Studienergebnis und -abschluss
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Vorzeitiger Studienabbruch
integer
C2718058 (UMLS CUI [1])
Early Ending of the Study or Termination
Code List
Vorzeitiger Studienabbruch
CL Item
Nein (0)
CL Item
Ja (1)
Item
Wenn ja, beendet von wem?
integer
C2348570 (UMLS CUI [1])
If yes, study termination by?
Code List
Wenn ja, beendet von wem?
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])
Comments on the patient
Item
Kommentare zum Patienten
text
C0947611 (UMLS CUI [1,1])
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])
Item
Unterschrift Prüfarzt
integer
C2346576 (UMLS CUI [1])
Are all inclusion criteria fulfilled?
Code List
Unterschrift Prüfarzt
CL Item
Nein (0)
CL Item
Ja (1)
Volver a la parte superior de la página 

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