ID

17929

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 (10)
  1. 10/7/16 10/7/16 -
  2. 10/10/16 10/10/16 -
  3. 10/11/16 10/11/16 -
  4. 10/17/16 10/17/16 -
  5. 10/18/16 10/18/16 -
  6. 10/21/16 10/21/16 -
  7. 10/23/16 10/23/16 -
  8. 10/24/16 10/24/16 -
  9. 10/27/16 10/27/16 -
  10. 11/2/16 11/2/16 -
Uploaded on

October 10, 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

English

Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

1 forms  
In-/Exclusion Criteria
Description

In-/Exclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Pat.-No.
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
The patient gave his or her consent on
Description

The patient gave his or her consent on

Data type

text

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C2985782
YYYY-MM-DD
Are all inclusion criteria fulfilled?
Description

Are all inclusion criteria fulfilled?

Data type

integer

Alias
UMLS CUI [1]
C1512693
Are none of the exclusion criteria fulfilled?
Description

Are none of the exclusion criteria fulfilled?

Data type

integer

Alias
UMLS CUI [1]
C2828389
Demographics, Vital Signs and Examinations
Description

Demographics, Vital Signs and Examinations

Alias
UMLS CUI-1
C1955348
UMLS CUI-3
C0518766
UMLS CUI-5
C0582103
Date of Screening
Description

Date of Screening

Data type

text

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
YYYY-MM-DD
Date of Birth
Description

Date of Birth

Data type

text

Measurement units
  • YYYY-MM
Alias
UMLS CUI [1]
C0421451
YYYY-MM
Sex
Description

Sex

Data type

integer

Alias
UMLS CUI [1]
C0079399
Nationality
Description

Nationality

Data type

integer

Alias
UMLS CUI [1]
C0027473
specify nationality
Description

specify nationality

Data type

text

Alias
UMLS CUI [1]
C0027473
Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
LDH
Description

LDH

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1]
C0202113
U/l
1. Systolic blood pressure
Description

1. Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
1. Diastolic blood pressure
Description

1. Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
2. Systolic blood pressure
Description

2. Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
2. Diastolic blood pressure
Description

2. Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
3. Systolic blood pressure
Description

3. Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
3. Diastolic blood pressure
Description

3. Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Sitting heart rate
Description

Sitting heart rate

Data type

integer

Measurement units
  • beats per minute
Alias
UMLS CUI [1]
C2029904
beats per minute
Body temperature
Description

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Physical examination
Description

Physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Abdominal ultrasound
Description

Abdominal ultrasound

Data type

integer

Alias
UMLS CUI [1]
C2348813
12-lead electrocardiogram
Description

12-lead electrocardiogram

Data type

integer

Alias
UMLS CUI [1]
C0430456
Bone marrow
Description

Bone marrow

Data type

integer

Alias
UMLS CUI [1]
C0005957
Circulatory Symptoms
Description

Circulatory Symptoms

Alias
UMLS CUI-1
C0476270
One year transfusion history
Description

One year transfusion history

Alias
UMLS CUI-1
C1519604
Preexisting and concomitant diseases
Description

Preexisting and concomitant diseases

Alias
UMLS CUI-1
C0243087
Visit 0 - FACIT
Description

Visit 0 - FACIT

Alias
UMLS CUI-1
C1512346
UMLS CUI-2
C3476791
Visit 0 - SF36
Description

Visit 0 - SF36

Alias
UMLS CUI-1
C1512346
UMLS CUI-2
C3640521
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Similar models

Screening and Observation Period 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
In-/Exclusion Criteria
C1512693 (UMLS CUI-1)
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])
Are all inclusion criteria fulfilled?
Code List
Are all inclusion criteria fulfilled?
CL Item
no (0)
CL Item
yes (1)
Item
Are none of the exclusion criteria fulfilled?
integer
C2828389 (UMLS CUI [1])
Are none of the exclusion criteria fulfilled?
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)
Date of Screening
Item
Date of Screening
text
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
text
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Nationality
integer
C0027473 (UMLS CUI [1])
Nationality
Code List
Nationality
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])
Item
Physical examination
integer
C0031809 (UMLS CUI [1])
Physical examination
Code List
Physical examination
CL Item
without pathologic findings (0)
CL Item
with pathologic findings (1)
Item
Abdominal ultrasound
integer
C2348813 (UMLS CUI [1])
Abdominal ultrasound
Code List
Abdominal ultrasound
CL Item
without pathologic findings (0)
CL Item
with pathologic findings (1)
Item
12-lead electrocardiogram
integer
C0430456 (UMLS CUI [1])
12-lead electrocardiogram
Code List
12-lead electrocardiogram
CL Item
without pathologic findings , 1=with pathologic findings (0)
Item
Bone marrow
integer
C0005957 (UMLS CUI [1])
Bone marrow
Code List
Bone marrow
CL Item
without pathologic findings  (0)
CL Item
with pathologic findings (1)
Item Group
Circulatory Symptoms
C0476270 (UMLS CUI-1)
Item Group
One year transfusion history
C1519604 (UMLS CUI-1)
Item Group
Preexisting and concomitant diseases
C0243087 (UMLS CUI-1)
Item Group
Visit 0 - FACIT
C1512346 (UMLS CUI-1)
C3476791 (UMLS CUI-2)
Item Group
Visit 0 - SF36
C1512346 (UMLS CUI-1)
C3640521 (UMLS CUI-2)
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