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ID
18054
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
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Uploaded on
October 17, 2016
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
Similar models
Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
In-/Exclusion Criteria
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
C0680251 (UMLS CUI-2)
Patient number
Item
Pat.-No.
integer
C1830427 (UMLS CUI [1])
The patient gave his or her consent on
Item
The patient gave his or her consent on
text
C2985782 (UMLS CUI [1])
Item
Are all inclusion criteria fulfilled?
integer
C1512693 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
Item
Are none of the exclusion criteria fulfilled?
integer
C2828389 (UMLS CUI [1])
Code List
Are none of the exclusion criteria fulfilled?
CL Item
no (0)
CL Item
yes (1)
Item Group
Demographics, Vital Signs and Examinations
C1955348 (UMLS CUI-1)
C0518766 (UMLS CUI-3)
C0582103 (UMLS CUI-5)
C0518766 (UMLS CUI-3)
C0582103 (UMLS CUI-5)
Date of Screening
Item
Date of Screening
text
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
text
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
German (1)
CL Item
other (2)
specify nationality
Item
specify nationality
text
C0027473 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
1. Systolic blood pressure
Item
1. Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
1. Diastolic blood pressure
Item
1. Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
2. Systolic blood pressure
Item
2. Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
2. Diastolic blood pressure
Item
2. Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
3. Systolic blood pressure
Item
3. Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
3. Diastolic blood pressure
Item
3. Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Sitting heart rate
Item
Sitting heart rate
integer
C2029904 (UMLS CUI [1])
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
CL Item
without pathologic findings (0)
CL Item
with pathologic findings (1)
CL Item
without pathologic findings (0)
CL Item
with pathologic findings (1)
CL Item
without pathologic findings , 1=with pathologic findings (0)
CL Item
without pathologic findings (0)
CL Item
with pathologic findings (1)
Walk distance
Item
Walk distance
integer
C3854161 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
Date of first Cold Agglutin Disease
Item
Date of first Cold Agglutin Disease diagnosis
date
C0011008 (UMLS CUI [1,1])
C0175816 (UMLS CUI [1,2])
C0175816 (UMLS CUI [1,2])
Item
Thrombophlebitis/Deep Vein Thrombosis
integer
C0040046 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0149871 (UMLS CUI [2])
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
Item
Portal Vein Thrombosis (Budd-Chiari)
integer
C0155773 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
Item
Acute Peripheral Vascular Occlusion
integer
C0240728 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
Item
Patient suffers from other accompanying illnesses?
integer
C0009488 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
Item
Only for Woman (under 50): Is the pregnancy test negativ?
integer
C0032976 (UMLS CUI [1])
Code List
Only for Woman (under 50): Is the pregnancy test negativ?
CL Item
no (0)
CL Item
yes (1)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (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])
Hemoglobin before transfusion
Item
Hemoglobin before transfusion
float
C0518015 (UMLS CUI [1])
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
Preexisting and concomitant diseases
C0243087 (UMLS CUI-1)
Item
The patient has no preexisting/concomitant diseases
integer
C0243087 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
CD No
Item
text
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
satisfied with talking about
Item
text
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
feel close to other people
integer
C2984048 (UMLS CUI [1])
C2984059 (UMLS CUI [2])
C2984059 (UMLS CUI [2])
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
satisfied with fighting against the illness
integer
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
cope with disease
integer
C0009967 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
tiredness limiting starting things
integer
C0015672 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
tiredness limits finishing things
integer
C0015672 (UMLS CUI [1,1])
C3259534 (UMLS CUI [1,2])
C3259534 (UMLS CUI [1,2])
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
need help with usual activities
integer
C3898152 (UMLS CUI [1])
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
frustrated by fatigue
integer
C0016770 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)
Item
fatigue limiting social activity
integer
C3898911 (UMLS CUI [1])
CL Item
not at all (0)
CL Item
a little bit (1)
CL Item
somewhat (2)
CL Item
quite a bit (3)
CL Item
very much (4)