ID
18131
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 (10)
- 2016-10-07 2016-10-07 -
- 2016-10-10 2016-10-10 -
- 2016-10-11 2016-10-11 -
- 2016-10-17 2016-10-17 -
- 2016-10-18 2016-10-18 -
- 2016-10-21 2016-10-21 -
- 2016-10-23 2016-10-23 -
- 2016-10-24 2016-10-24 -
- 2016-10-27 2016-10-27 -
- 2016-11-02 2016-11-02 -
Uppladdad den
21 oktober 2016
DOI
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Licens
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
Beskrivning
Demografie, Vitalzeichen und Untersuchungen
Alias
- UMLS CUI-1
- C1955348
- UMLS CUI-2
- C0518766
- UMLS CUI-3
- C0582103
Beskrivning
Date of Screening
Datatyp
text
Måttenheter
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1710477
Beskrivning
Date of Birth
Datatyp
text
Måttenheter
- YYYY-MM
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Nationality
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027473
Beskrivning
specify nationality
Datatyp
text
Alias
- UMLS CUI [1]
- C0027473
Beskrivning
Height
Datatyp
float
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
LDH
Datatyp
float
Måttenheter
- U/l
Alias
- UMLS CUI [1]
- C0202113
Beskrivning
1. Systolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
1. Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
2. Systolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
2. Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
3. Systolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
3. Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Sitting heart rate
Datatyp
integer
Måttenheter
- beats per minute
Alias
- UMLS CUI [1]
- C2029904
Beskrivning
Body temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Physical examination
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Abdominal ultrasound
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348813
Beskrivning
12-lead electrocardiogram
Datatyp
integer
Alias
- UMLS CUI [1]
- C0430456
Beskrivning
Bone marrow
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005957
Beskrivning
Walk distance
Datatyp
integer
Måttenheter
- Meter
Alias
- UMLS CUI [1]
- C3854161
Beskrivning
dyspnea
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013404
Beskrivning
Kardiovaskuläre Symptome
Alias
- UMLS CUI-1
- C0476270
Beskrivning
Date of first Cold Agglutin Disease
Datatyp
date
Måttenheter
- YYYY-MM-DD
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0175816
Beskrivning
Thrombophlebitis/Deep Vein Thrombosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0040046
- UMLS CUI [2]
- C0149871
Beskrivning
Pulmonary Embolus
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034065
Beskrivning
Cerebrovascular Accident
Datatyp
integer
Alias
- UMLS CUI [1]
- C0038454
Beskrivning
Amputation
Datatyp
integer
Alias
- UMLS CUI [1]
- C0002688
Beskrivning
Myocardial Infarction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Transient Ischemic Attack
Datatyp
integer
Alias
- UMLS CUI [1]
- C0007787
Beskrivning
Unstable Angina
Datatyp
integer
Alias
- UMLS CUI [1]
- C0002965
Beskrivning
Renal Vein Thrombosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0238457
Beskrivning
Mesenteric Vein Thrombosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0267412
Beskrivning
Portal Vein Thrombosis (Budd-Chiari)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0155773
Beskrivning
Gangrene
Datatyp
integer
Alias
- UMLS CUI [1]
- C0017086
Beskrivning
Acute Peripheral Vascular Occlusion
Datatyp
integer
Alias
- UMLS CUI [1]
- C0240728
Beskrivning
Sudden Death
Datatyp
integer
Alias
- UMLS CUI [1]
- C0011071
Beskrivning
Patient suffers from other accompanying illnesses?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
Only for Woman (under 50): Is the pregnancy test negativ?
Datatyp
integer
Alias
- UMLS CUI [1]
- C0032976
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Signature date
Datatyp
date
Alias
- UMLS CUI [1]
- C0807937
Beskrivning
Investigators signature
Datatyp
integer
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Einjahres Transfusionsgeschichte
Alias
- UMLS CUI-1
- C1519604
Beskrivning
Date of blood transfusion
Datatyp
date
Måttenheter
- YYYY-MM-DD
Alias
- UMLS CUI [1]
- C1264703
Beskrivning
Number of units
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449961
Beskrivning
Hemoglobin before transfusion
Datatyp
float
Måttenheter
- ulHGB
Alias
- UMLS CUI [1]
- C0518015
Beskrivning
Any special events circumstances transfusion?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Beskrivning
if yes, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1879316
Beskrivning
Signature date
Datatyp
date
Alias
- UMLS CUI [1]
- C0807937
Beskrivning
Investigators signature
Datatyp
integer
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Vor- und Begleiterkrankungen
Alias
- UMLS CUI-1
- C0243087
Beskrivning
Concomitant disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0243087
Beskrivning
Signature date
Datatyp
date
Alias
- UMLS CUI [1]
- C0807937
Beskrivning
Investigators signature
Datatyp
integer
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Preexisting and concomitant
Alias
- UMLS CUI-1
- C0243087
Beskrivning
Visite 0 - FACIT
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3476791
Beskrivning
lack of vitality
Datatyp
integer
Alias
- UMLS CUI [1]
- C1337102
Beskrivning
nausea
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027497
Beskrivning
General health deterioration
Datatyp
integer
Alias
- UMLS CUI [1]
- C0563273
Beskrivning
pain
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
treatment side-effects
Datatyp
integer
Alias
- UMLS CUI [1]
- C0879626
Beskrivning
feeling of illness
Datatyp
integer
Alias
- UMLS CUI [1]
- C0231218
Beskrivning
bedrest
Datatyp
integer
Alias
- UMLS CUI [1]
- C0004910
Beskrivning
interacts with close friends
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518615
Beskrivning
family support
Datatyp
integer
Alias
- UMLS CUI [1]
- C0150232
Beskrivning
receives support from friends
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984072
Beskrivning
accepts disease
Datatyp
integer
Beskrivning
satisfied with talking about disease
Datatyp
integer
Beskrivning
feel close to other people
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984048
- UMLS CUI [2]
- C2984059
Beskrivning
satisfied with sex life
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984060
Beskrivning
sadness
Datatyp
integer
Alias
- UMLS CUI [1]
- C3827348
Beskrivning
satisfied with fighting against the illness
Datatyp
integer
Beskrivning
losing hope
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984056
Beskrivning
nervousness
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027769
Beskrivning
worries about death
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984076
Beskrivning
worries about condition
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984075
Beskrivning
able to work
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984044
Beskrivning
satisfied with work
Datatyp
integer
Alias
- UMLS CUI [1]
- C0578800
Beskrivning
able to enjoy life
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984051
Beskrivning
cope with disease
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0009967
- UMLS CUI [1,2]
- C0012634
Beskrivning
sleeping
Datatyp
integer
Alias
- UMLS CUI [1]
- C0474396
Beskrivning
able to enjoy leisure
Datatyp
integer
Alias
- UMLS CUI [1]
- C2984052
Beskrivning
currently satisfied with life
Datatyp
integer
Alias
- UMLS CUI [1]
- C1954023
Beskrivning
fatigue
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
weak
Datatyp
integer
Alias
- UMLS CUI [1]
- C3714552
Beskrivning
listless
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023380
Beskrivning
tired
Datatyp
integer
Alias
- UMLS CUI [1]
- C0848717
Beskrivning
tiredness limiting starting things
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0439659
Beskrivning
tiredness limits finishing things
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3259534
Beskrivning
having energy
Datatyp
integer
Alias
- UMLS CUI [1]
- C0542479
Beskrivning
able to do usual activities
Datatyp
integer
Alias
- UMLS CUI [1]
- C0441655
Beskrivning
sleep during daytime
Datatyp
integer
Alias
- UMLS CUI [1]
- C4075948
Beskrivning
too tired to eat
Datatyp
integer
Alias
- UMLS CUI [1]
- C3897355
Beskrivning
need help with usual activities
Datatyp
integer
Alias
- UMLS CUI [1]
- C3898152
Beskrivning
frustrated by fatigue
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0016770
- UMLS CUI [1,2]
- C0015672
Beskrivning
fatigue limiting social activity
Datatyp
integer
Alias
- UMLS CUI [1]
- C3898911
Beskrivning
Visit 0 - SF36
Alias
- UMLS CUI-1
- C1512346
- UMLS CUI-2
- C3640521
Beskrivning
general health condition
Datatyp
integer
Alias
- UMLS CUI [1]
- C1142435
Beskrivning
current state of health
Datatyp
integer
Beskrivning
limited in activities
Datatyp
text
Beskrivning
Vigorous activities
Datatyp
integer
Alias
- UMLS CUI [1]
- C3827557
Beskrivning
Moderate activities
Datatyp
integer
Alias
- UMLS CUI [1]
- C3833417
Beskrivning
Lifting or carrying groceries
Datatyp
integer
Alias
- UMLS CUI [1]
- C3829286
Beskrivning
Climbing several flights of stairs
Datatyp
integer
Alias
- UMLS CUI [1]
- C3831080
Beskrivning
Climbing one flight of stairs
Datatyp
integer
Beskrivning
Bending, kneeling, or stooping
Datatyp
integer
Alias
- UMLS CUI [1]
- C3831371
Beskrivning
Walking more than a mile
Datatyp
integer
Alias
- UMLS CUI [1]
- C3827523
Beskrivning
Walking several blocks
Datatyp
integer
Alias
- UMLS CUI [1]
- C3827521
Beskrivning
Walking one block
Datatyp
integer
Alias
- UMLS CUI [1]
- C3827522
Beskrivning
Bathing or dressing yourself
Datatyp
integer
Alias
- UMLS CUI [1]
- C3831396
Beskrivning
problems in past 4 weeks
Datatyp
text
Beskrivning
Cut down the amount of time you spent on work or other activities
Datatyp
integer
Alias
- UMLS CUI [1]
- C0585074
Beskrivning
Accomplished less than you would like
Datatyp
integer
Alias
- UMLS CUI [1]
- C3900126
Beskrivning
Were limited in the kind of work or other activities
Datatyp
integer
Alias
- UMLS CUI [1]
- C3898591
Beskrivning
Had difficulty performing the work or other activities (for example, it took extra effort)
Datatyp
integer
Alias
- UMLS CUI [1]
- C3898961
Beskrivning
emotional problems
Datatyp
text
Beskrivning
Cut down the amount of time you spent on work or other activities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0585074
- UMLS CUI [1,2]
- C0677660
Beskrivning
Accomplished less than you would like
Datatyp
integer
Alias
- UMLS CUI [1]
- C3900126
Beskrivning
Didnt do work or other activities as carefully as usual
Datatyp
integer
Alias
- UMLS CUI [1]
- C3899381
Beskrivning
emotional problems limiting social activities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0677660
- UMLS CUI [1,2]
- C3829529
Beskrivning
bodily pain during the past 4 weeks
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
pain interfere with your normal work
Datatyp
integer
Alias
- UMLS CUI [1]
- C3898033
Beskrivning
feelings last 4 weeks
Datatyp
text
Beskrivning
Did you feel full of pep?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3484313
Beskrivning
Have you been a very nervous person?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3475469
Beskrivning
Have you felt so down in the dumps that nothing could cheer you up?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3475473
Beskrivning
Have you felt calm and peaceful?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3475471
Beskrivning
Did you have a lot of energy?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3484316
Beskrivning
Have you felt downhearted and blue?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3475472
Beskrivning
Did you feel worn out?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3484315
Beskrivning
Have you been a happy person?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3475468
Beskrivning
Did you feel tired?
Datatyp
integer
Alias
- UMLS CUI [1]
- C3484314
Beskrivning
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.)?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0677660
- UMLS CUI [1,2]
- C0521102
- UMLS CUI [1,3]
- C3641834
Beskrivning
How TRUE or FALSE is each of the following statements for you.
Datatyp
text
Beskrivning
I seem to get sick a little easier than other people
Datatyp
integer
Alias
- UMLS CUI [1]
- C3899028
Beskrivning
I am as healthy as anybody I know
Datatyp
integer
Alias
- UMLS CUI [1]
- C3900054
Beskrivning
I expect my health to get worse
Datatyp
integer
Alias
- UMLS CUI [1]
- C3475697
Beskrivning
My health is excellent
Datatyp
integer
Alias
- UMLS CUI [1]
- C3476206
Similar models
Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952
C0680251 (UMLS CUI-2)
C0518766 (UMLS CUI-2)
C0582103 (UMLS CUI-3)
C1710477 (UMLS CUI [1,2])
C0175816 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
C0449961 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
C2984059 (UMLS CUI [2])
C0677660 (UMLS CUI [1,2])
C3829529 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,2])
C3641834 (UMLS CUI [1,3])