ID

42046

Description

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

Keywords

Versions (3)
  1. 10/27/16 10/27/16 -
  2. 10/27/16 10/27/16 -
  3. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

March 15, 2021

DOI

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License

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

German English

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

1 forms  
Medications
Description

Medications

Alias
UMLS CUI-1
C0013227
Number of medication
Description

Number of medication

Data type

integer

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

Name of medication

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose of Medication
Description

medication dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Start of therapy
Description

Start of therapy

Data type

date

Alias
UMLS CUI [1]
C3173309
Stop of therapy
Description

therapy Stop date

Data type

date

Alias
UMLS CUI [1]
C1531784
Ongoing
Description

Ongoing medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Indication
Description

indication for medication

Data type

text

Alias
UMLS CUI [1]
C2826696
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Number of Adverse Event
Description

Number of Adverse Event

Data type

integer

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

Description of Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Start of treatment
Description

Start of treatment

Data type

date

Alias
UMLS CUI [1]
C3173309
End of treatment
Description

End of treatment

Data type

date

Alias
UMLS CUI [1]
C1531784
Intensity
Description

adverse event intensity

Data type

text

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

Adverse event related to study treatment

Data type

boolean

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

Action taken with study medication

Data type

boolean

Alias
UMLS CUI [1]
C1704758
Outcome
Description

Adverse event outcome

Data type

text

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

is the adverse event serious

Data type

boolean

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

Transfusion history during the entry study

Alias
UMLS CUI-1
C1519604
Date of blood transfusion
Description

Date of blood transfusion

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1264703
YYYY-MM-DD
Number of units
Description

Number of units

Data type

integer

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

Any special events circumstances transfusion?

Data type

integer

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

if yes, please specify

Data type

text

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

Sub-Itemgroup: Investigator's signature

Data type

date

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

Sub-Itemgroup: Investigator's signature

Data type

integer

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

Conclusion of the Study and Termination

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

Early Ending of the Study or Termination

Data type

integer

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

If yes, study termination by?

Data type

integer

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

If yes, date of the Termination:

Data type

date

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

If yes, reason for the study termination

Data type

text

specify
Description

specify

Data type

text

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

Comments on the patient

Data type

text

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

Investigators name

Data type

text

Alias
UMLS CUI [1]
C2826892
Stamp
Description

Stamp

Data type

text

Alias
UMLS CUI [1]
C0032755
Signature date
Description

Sub-Itemgroup: Investigator's signature

Data type

date

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

Sub-Itemgroup: Investigator's signature

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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