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Informazione:
Errore:
ID
18281
Descrizione
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
collegamento
https://clinicaltrials.gov/ct2/show/NCT01303952
Keywords
versioni (3)
- 27/10/16 27/10/16 -
- 27/10/16 27/10/16 -
- 15/03/21 15/03/21 - Dr. rer. medic Philipp Neuhaus
Caricato su
27 ottobre 2016
DOI
Per favore, per richiedere un accesso.
Licenza
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
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Number of medication
Item
Number of medication
integer
C0237753 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Name of medication
Item
Name of medication
text
C0013227 (UMLS CUI [1])
medication dose
Item
Dose of Medication
float
C3174092 (UMLS CUI [1])
Start of therapy
Item
Start of therapy
date
C1531783 (UMLS CUI [1])
therapy Stop date
Item
Stop of therapy
date
C1531784 (UMLS CUI [1])
Ongoing medication
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
indication for medication
Item
Indication
text
C2826696 (UMLS CUI [1])
Number of Adverse Event
Item
Number of Adverse Event
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Description of Adverse Event
Item
Description of Adverse Event
text
C0877248 (UMLS CUI [1])
Start of treatment
Item
Start of treatment
date
C1531783 (UMLS CUI [1])
End of treatment
Item
End of treatment
date
C1531784 (UMLS CUI [1])
adverse event intensity
Item
Intensity
text
C1710066 (UMLS CUI [1])
Adverse event related to study treatment
Item
Related to the Study Medication
boolean
C1510821 (UMLS CUI [1])
Action taken with study medication
Item
Action taken with study medication
boolean
C1704758 (UMLS CUI [1])
Adverse event outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
is the adverse event serious
Item
Is the AE serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Transfusion history during the entry study
C1519604 (UMLS CUI-1)
Date of blood transfusion
Item
Date of blood transfusion
date
C1264703 (UMLS CUI [1])
Number of units
Item
Number of units
integer
C0086252 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
C0449961 (UMLS CUI [1,2])
Item
Any special events circumstances transfusion?
integer
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
CL Item
no (0)
CL Item
yes (1)
if yes, please specify
Item
if yes, please specify
text
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
Item Group
Conclusion of the Study and Termination
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0008972 (UMLS CUI-2)
Item
Early Ending of the Study or Termination
integer
C2718058 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
CL Item
the physician (1)
CL Item
the patient (2)
If yes, date of the Termination:
Item
If yes, date of the Termination:
date
C2983670 (UMLS CUI [1])
If yes, reason for the study termination
Item
text
specify
Item
specify
text
C0566251 (UMLS CUI [1,1])
C2348570 (UMLS CUI [1,2])
C2348570 (UMLS CUI [1,2])
Comments on the patient
Item
Comments on the patient
text
C0947611 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
Investigators name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Stamp
Item
Stamp
text
C0032755 (UMLS CUI [1])
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)