ID
18077
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)
- 10/7/16 10/7/16 -
- 10/10/16 10/10/16 -
- 10/11/16 10/11/16 -
- 10/17/16 10/17/16 -
- 10/18/16 10/18/16 -
- 10/21/16 10/21/16 -
- 10/23/16 10/23/16 -
- 10/24/16 10/24/16 -
- 10/27/16 10/27/16 -
- 11/2/16 11/2/16 -
Uploaded on
October 18, 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
Description
Demographics, Vital Signs and Examinations
Alias
- UMLS CUI-1
- C1955348
- UMLS CUI-3
- C0518766
- UMLS CUI-5
- C0582103
Description
Itemgroup: Date of Screening
Data type
text
Measurement units
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710477
Description
Sub-Itemgroup: Demographics
Data type
text
Measurement units
- YYYY-MM
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Sub-Itemgroup: Demographics
Data type
integer
Alias
- UMLS CUI [1]
- C0027473
Description
Sub-Itemgroup: Demographics
Data type
text
Alias
- UMLS CUI [1]
- C0027473
Description
Sub-Itemgroup: Demographics
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Sub-Itemgroup: Demographics
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Sub-Itemgroup: Demographics
Data type
float
Measurement units
- U/l
Alias
- UMLS CUI [1]
- C0202113
Description
Sub-Itemgroup: Vital Signs
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Sub-Itemgroup: Vital Signs
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Sub-Itemgroup: Vital Signs
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Sub-Itemgroup: Vital Signs
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Sub-Itemgroup: Vital Signs
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Sub-Itemgroup: Vital Signs
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Sub-Itemgroup: Vital Signs
Data type
integer
Measurement units
- beats per minute
Alias
- UMLS CUI [1]
- C2029904
Description
Sub-Itemgroup: Vital Signs
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Sub-Itemgroup: Examinations
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
Description
Sub-Itemgroup: Examinations
Data type
integer
Alias
- UMLS CUI [1]
- C2348813
Description
Sub-Itemgroup: Examinations
Data type
integer
Alias
- UMLS CUI [1]
- C0430456
Description
Sub-Itemgroup: Examinations
Data type
integer
Alias
- UMLS CUI [1]
- C0005957
Description
Sub-Itemgroup: Six-Minute Walk Test
Data type
integer
Measurement units
- Meter
Alias
- UMLS CUI [1]
- C3854161
Description
Sub-Itemgroup: Six-Minute Walk Test
Data type
integer
Alias
- UMLS CUI [1]
- C0013404
Description
Circulatory Symptoms
Alias
- UMLS CUI-1
- C0476270
Description
Date of first Cold Agglutin Disease
Data type
date
Measurement units
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0175816
Description
Thrombophlebitis/Deep Vein Thrombosis
Data type
integer
Alias
- UMLS CUI [1]
- C0040046
- UMLS CUI [2]
- C0149871
Description
Pulmonary Embolus
Data type
integer
Alias
- UMLS CUI [1]
- C0034065
Description
Cerebrovascular Accident
Data type
integer
Alias
- UMLS CUI [1]
- C0038454
Description
Amputation
Data type
integer
Alias
- UMLS CUI [1]
- C0002688
Description
Myocardial Infarction
Data type
integer
Alias
- UMLS CUI [1]
- C0027051
Description
Transient Ischemic Attack
Data type
integer
Alias
- UMLS CUI [1]
- C0007787
Description
Unstable Angina
Data type
integer
Alias
- UMLS CUI [1]
- C0002965
Description
Renal Vein Thrombosis
Data type
integer
Alias
- UMLS CUI [1]
- C0238457
Description
Mesenteric Vein Thrombosis
Data type
integer
Alias
- UMLS CUI [1]
- C0267412
Description
Portal Vein Thrombosis (Budd-Chiari)
Data type
integer
Alias
- UMLS CUI [1]
- C0155773
Description
Gangrene
Data type
integer
Alias
- UMLS CUI [1]
- C0017086
Description
Acute Peripheral Vascular Occlusion
Data type
integer
Alias
- UMLS CUI [1]
- C0240728
Description
Sudden Death
Data type
integer
Alias
- UMLS CUI [1]
- C0011071
Description
Patient suffers from other accompanying illnesses?
Data type
integer
Alias
- UMLS CUI [1]
- C0009488
Description
Only for Woman (under 50): Is the pregnancy test negativ?
Data type
integer
Alias
- UMLS CUI [1]
- C0032976
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Sub-Itemgroup: Investigator's signature
Data type
date
Alias
- UMLS CUI [1]
- C0807937
Description
Sub-Itemgroup: Investigator's signature
Data type
integer
Alias
- UMLS CUI [1]
- C2346576
Description
One year transfusion history
Alias
- UMLS CUI-1
- C1519604
Description
Date of blood transfusion
Data type
date
Measurement units
- YYYY-MM-DD
Alias
- UMLS CUI [1]
- C1264703
Description
Number of units
Data type
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449961
Description
Hemoglobin before transfusion
Data type
float
Measurement units
- ulHGB
Alias
- UMLS CUI [1]
- C0518015
Description
Any special events circumstances transfusion?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Description
if yes, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Description
Sub-Itemgroup: Investigator's signature
Data type
date
Alias
- UMLS CUI [1]
- C0807937
Description
Sub-Itemgroup: Investigator's signature
Data type
integer
Alias
- UMLS CUI [1]
- C2346576
Description
Preexisting and concomitant diseases
Alias
- UMLS CUI-1
- C0243087
Description
Concomitant disease
Data type
integer
Alias
- UMLS CUI [1]
- C0243087
Description
Sub-Itemgroup: Investigator's signature
Data type
date
Alias
- UMLS CUI [1]
- C0807937
Description
Sub-Itemgroup: Investigator's signature
Data type
integer
Alias
- UMLS CUI [1]
- C2346576
Description
Preexisting and concomitant
Alias
- UMLS CUI-1
- C0243087
Description
Visit 0 - FACIT
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3476791
Description
lack of vitality
Data type
integer
Alias
- UMLS CUI [1]
- C1337102
Description
nausea
Data type
integer
Alias
- UMLS CUI [1]
- C0027497
Description
General health deterioration
Data type
integer
Alias
- UMLS CUI [1]
- C0563273
Description
pain
Data type
integer
Alias
- UMLS CUI [1]
- C0030193
Description
treatment side-effects
Data type
integer
Alias
- UMLS CUI [1]
- C0879626
Description
feeling of illness
Data type
integer
Alias
- UMLS CUI [1]
- C0231218
Description
bedrest
Data type
integer
Alias
- UMLS CUI [1]
- C0004910
Description
interacts with close friends
Data type
integer
Alias
- UMLS CUI [1]
- C0518615
Description
family support
Data type
integer
Alias
- UMLS CUI [1]
- C0150232
Description
receives support from friends
Data type
integer
Alias
- UMLS CUI [1]
- C2984072
Description
accepts disease
Data type
integer
Description
satisfied with talking about
Data type
text
Description
satisfied with talking about disease
Data type
integer
Description
feel close to other people
Data type
integer
Alias
- UMLS CUI [1]
- C2984048
- UMLS CUI [2]
- C2984059
Description
satisfied with sex life
Data type
integer
Alias
- UMLS CUI [1]
- C2984060
Description
sadness
Data type
integer
Alias
- UMLS CUI [1]
- C3827348
Description
satisfied with fighting against the illness
Data type
integer
Description
losing hope
Data type
integer
Alias
- UMLS CUI [1]
- C2984056
Description
nervousness
Data type
integer
Alias
- UMLS CUI [1]
- C0027769
Description
worries about death
Data type
integer
Alias
- UMLS CUI [1]
- C2984076
Description
worries about condition
Data type
integer
Alias
- UMLS CUI [1]
- C2984075
Description
able to work
Data type
integer
Alias
- UMLS CUI [1]
- C2984044
Description
satisfied with work
Data type
integer
Alias
- UMLS CUI [1]
- C0578800
Description
able to enjoy life
Data type
integer
Alias
- UMLS CUI [1]
- C2984051
Description
cope with disease
Data type
integer
Alias
- UMLS CUI [1,1]
- C0009967
- UMLS CUI [1,2]
- C0012634
Description
sleeping
Data type
integer
Alias
- UMLS CUI [1]
- C0474396
Description
able to enjoy leisure
Data type
integer
Alias
- UMLS CUI [1]
- C2984052
Description
currently satisfied with life
Data type
integer
Alias
- UMLS CUI [1]
- C1954023
Description
fatigue
Data type
integer
Alias
- UMLS CUI [1]
- C0015672
Description
weak
Data type
integer
Alias
- UMLS CUI [1]
- C3714552
Description
listless
Data type
integer
Alias
- UMLS CUI [1]
- C0023380
Description
tired
Data type
integer
Alias
- UMLS CUI [1]
- C0848717
Description
tiredness limiting starting things
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0439659
Description
tiredness limits finishing things
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3259534
Description
having energy
Data type
integer
Alias
- UMLS CUI [1]
- C0542479
Description
able to do usual activities
Data type
integer
Alias
- UMLS CUI [1]
- C0441655
Description
sleep during daytime
Data type
integer
Alias
- UMLS CUI [1]
- C4075948
Description
too tired to eat
Data type
integer
Alias
- UMLS CUI [1]
- C3897355
Description
need help with usual activities
Data type
integer
Alias
- UMLS CUI [1]
- C3898152
Description
frustrated by fatigue
Data type
integer
Alias
- UMLS CUI [1,1]
- C0016770
- UMLS CUI [1,2]
- C0015672
Description
fatigue limiting social activity
Data type
integer
Alias
- UMLS CUI [1]
- C3898911
Description
Visit 0 - SF36
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3640521
Description
general health condition
Data type
integer
Alias
- UMLS CUI [1]
- C1142435
Description
current state of health
Data type
integer
Description
limited in activities
Data type
text
Description
Vigorous activities
Data type
integer
Alias
- UMLS CUI [1]
- C3827557
Description
Moderate activities
Data type
integer
Alias
- UMLS CUI [1]
- C3833417
Description
Lifting or carrying groceries
Data type
integer
Alias
- UMLS CUI [1]
- C3829286
Description
Climbing several flights of stairs
Data type
integer
Alias
- UMLS CUI [1]
- C3831080
Description
Climbing one flight of stairs
Data type
integer
Description
Bending, kneeling, or stooping
Data type
integer
Alias
- UMLS CUI [1]
- C3831371
Description
Walking more than a mile
Data type
integer
Alias
- UMLS CUI [1]
- C3827523
Description
Walking several blocks
Data type
integer
Alias
- UMLS CUI [1]
- C3827521
Description
Walking one block
Data type
integer
Alias
- UMLS CUI [1]
- C3827522
Description
Bathing or dressing yourself
Data type
integer
Alias
- UMLS CUI [1]
- C3831396
Description
problems in past 4 weeks
Data type
text
Description
Cut down the amount of time you spent on work or other activities
Data type
integer
Alias
- UMLS CUI [1]
- C0585074
Description
Accomplished less than you would like
Data type
integer
Alias
- UMLS CUI [1]
- C3900126
Description
Were limited in the kind of work or other activities
Data type
integer
Alias
- UMLS CUI [1]
- C3898591
Description
Had difficulty performing the work or other activities (for example, it took extra effort)
Data type
integer
Alias
- UMLS CUI [1]
- C3898961
Description
emotional problems
Data type
text
Description
Cut down the amount of time you spent on work or other activities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0585074
- UMLS CUI [1,2]
- C0677660
Description
Accomplished less than you would like
Data type
integer
Alias
- UMLS CUI [1]
- C3900126
Description
Didnt do work or other activities as carefully as usual
Data type
integer
Alias
- UMLS CUI [1]
- C3899381
Description
emotional problems limiting social activities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0677660
- UMLS CUI [1,2]
- C3829529
Description
bodily pain during the past 4 weeks
Data type
integer
Alias
- UMLS CUI [1]
- C0030193
Description
pain interfere with your normal work
Data type
integer
Alias
- UMLS CUI [1]
- C3898033
Description
feelings last 4 weeks
Data type
text
Description
Did you feel full of pep?
Data type
integer
Alias
- UMLS CUI [1]
- C3484313
Description
Have you been a very nervous person?
Data type
integer
Alias
- UMLS CUI [1]
- C3475469
Description
Have you felt so down in the dumps that nothing could cheer you up?
Data type
integer
Alias
- UMLS CUI [1]
- C3475473
Description
Have you felt calm and peaceful?
Data type
integer
Alias
- UMLS CUI [1]
- C3475471
Description
Did you have a lot of energy?
Data type
integer
Alias
- UMLS CUI [1]
- C3484316
Description
Have you felt downhearted and blue?
Data type
integer
Alias
- UMLS CUI [1]
- C3475472
Description
Did you feel worn out?
Data type
integer
Alias
- UMLS CUI [1]
- C3484315
Description
Have you been a happy person?
Data type
integer
Alias
- UMLS CUI [1]
- C3475468
Description
Did you feel tired?
Data type
integer
Alias
- UMLS CUI [1]
- C3484314
Description
During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0677660
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C3641834
Description
How TRUE or FALSE is each of the following statements for you.
Data type
text
Description
I seem to get sick a little easier than other people
Data type
integer
Alias
- UMLS CUI [1]
- C3899028
Description
I am as healthy as anybody I know
Data type
integer
Alias
- UMLS CUI [1]
- C3900054
Description
I expect my health to get worse
Data type
integer
Alias
- UMLS CUI [1]
- C3475697
Description
My health is excellent
Data type
integer
Alias
- UMLS CUI [1]
- C3476206
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