ID

42046

Beskrivning

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

Länk

https://clinicaltrials.gov/ct2/show/NCT01303952

Nyckelord

Versioner (3)
  1. 2016-10-27 2016-10-27 -
  2. 2016-10-27 2016-10-27 -
  3. 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Uppladdad den

15 mars 2021

DOI

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Licens

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

Tysk Engelsk

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

1 Formulär  
Medications
Beskrivning

Medications

Alias
UMLS CUI-1
C0013227
Number of medication
Beskrivning

Number of medication

Datatyp

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0013227
Name of medication
Beskrivning

Name of medication

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose of Medication
Beskrivning

medication dose

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Start of therapy
Beskrivning

Start of therapy

Datatyp

date

Alias
UMLS CUI [1]
C3173309
Stop of therapy
Beskrivning

therapy Stop date

Datatyp

date

Alias
UMLS CUI [1]
C1531784
Ongoing
Beskrivning

Ongoing medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Indication
Beskrivning

indication for medication

Datatyp

text

Alias
UMLS CUI [1]
C2826696
Adverse Events
Beskrivning

Adverse Events

Alias
UMLS CUI-1
C0877248
Number of Adverse Event
Beskrivning

Number of Adverse Event

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Description of Adverse Event
Beskrivning

Description of Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Start of treatment
Beskrivning

Start of treatment

Datatyp

date

Alias
UMLS CUI [1]
C3173309
End of treatment
Beskrivning

End of treatment

Datatyp

date

Alias
UMLS CUI [1]
C1531784
Intensity
Beskrivning

adverse event intensity

Datatyp

text

Alias
UMLS CUI [1]
C1710066
Related to the Study Medication
Beskrivning

Adverse event related to study treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C1510821
Action taken with study medication
Beskrivning

Action taken with study medication

Datatyp

boolean

Alias
UMLS CUI [1]
C1704758
Outcome
Beskrivning

Adverse event outcome

Datatyp

text

Alias
UMLS CUI [1]
C1705586
Is the AE serious?
Beskrivning

is the adverse event serious

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Transfusion history during the entry study
Beskrivning

Transfusion history during the entry study

Alias
UMLS CUI-1
C1519604
Date of blood transfusion
Beskrivning

Date of blood transfusion

Datatyp

date

Måttenheter
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1264703
YYYY-MM-DD
Number of units
Beskrivning

Number of units

Datatyp

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0449961
Any special events circumstances transfusion?
Beskrivning

Any special events circumstances transfusion?

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1879316
if yes, please specify
Beskrivning

if yes, please specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1879316
Signature date
Beskrivning

Sub-Itemgroup: Investigator's signature

Datatyp

date

Alias
UMLS CUI [1]
C0807937
Investigator's signature
Beskrivning

Sub-Itemgroup: Investigator's signature

Datatyp

integer

Alias
UMLS CUI [1]
C2346576
Conclusion of the Study and Termination
Beskrivning

Conclusion of the Study and Termination

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Early Ending of the Study or Termination
Beskrivning

Early Ending of the Study or Termination

Datatyp

integer

Alias
UMLS CUI [1]
C2718058
If yes, study termination by?
Beskrivning

If yes, study termination by?

Datatyp

integer

Alias
UMLS CUI [1]
C2348570
If yes, date of the Termination:
Beskrivning

If yes, date of the Termination:

Datatyp

date

Alias
UMLS CUI [1]
C2983670
If yes, reason for the study termination
Beskrivning

If yes, reason for the study termination

Datatyp

text

specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2348570
Comments on the patient
Beskrivning

Comments on the patient

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0030705
Investigator's name
Beskrivning

Investigators name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Stamp
Beskrivning

Stamp

Datatyp

text

Alias
UMLS CUI [1]
C0032755
Signature date
Beskrivning

Sub-Itemgroup: Investigator's signature

Datatyp

date

Alias
UMLS CUI [1]
C0807937
Investigator's signature
Beskrivning

Sub-Itemgroup: Investigator's signature

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Medications
C0013227 (UMLS CUI-1)
Number of medication
Item
Number of medication
integer
C0237753 (UMLS CUI [1,1])
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
C3173309 (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])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Number of Adverse Event
Item
Number of Adverse Event
integer
C0877248 (UMLS CUI [1,1])
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
C3173309 (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])
Item
Any special events circumstances transfusion?
integer
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
Are all inclusion criteria fulfilled?
Code List
Any special events circumstances transfusion?
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])
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
Item
Investigator's signature
integer
C2346576 (UMLS CUI [1])
Are all inclusion criteria fulfilled?
Code List
Investigator's signature
CL Item
no (0)
CL Item
yes (1)
Item Group
Conclusion of the Study and Termination
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Early Ending of the Study or Termination
integer
C2718058 (UMLS CUI [1])
Early Ending of the Study or Termination
Code List
Early Ending of the Study or Termination
CL Item
no (0)
CL Item
yes (1)
Item
If yes, study termination by?
integer
C2348570 (UMLS CUI [1])
If yes, study termination by?
Code List
If yes, study termination by?
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])
Comments on the patient
Item
Comments on the patient
text
C0947611 (UMLS CUI [1,1])
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])
Item
Investigator's signature
integer
C2346576 (UMLS CUI [1])
Are all inclusion criteria fulfilled?
Code List
Investigator's signature
CL Item
no (0)
CL Item
yes (1)
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